A Market Overview of the Generic Industry Today 

	The outlook for the generic drug industry for the next several years is promising yet volatile. It will benefit from an unprecedented number of major brand-name drug patent expirations, but will also be confronted by a changing health care landscape and uncertain economy.

	Generic medications are currently a bright spot in the prescription medication market. Sales of generic medications continued to rise even as the volume of prescription medicines consumed overall rose at historically low levels in 2010. According to the IMS Institute for Healthcare Informatics, there was a 2.3% increase in spending on prescription medications in the United States in 2010—strikingly lower than the 5.1% growth rate in 2009. But the breakdown of 2010 spending figures in an April 2011 IMS report reveals that “Spending on brand-name drugs declined 0.7% in 2010, while spending on branded and unbranded generics rose 4.5% and 21.7%, respectively.”

	The main factor behind the slowdown in overall prescription pharmaceutical spending rates and the growth in generics in 2010 as the loss of patent protection for a number of major branded products. Also playing a role was the slower demand and less spending on new therapies as fewer patients visited their health care providers and initiated new chronic therapy treatments, due to poor economic conditions.

	In 2010, generic medicines accounted for 78% of prescriptions dispensed by retail drugstores and long-term care facilities—a historic high that is 4% higher than 2009 figures. All 10 of the most-prescribed medications in the United States were generic drugs, led by the generic equivalents of Vicodin (hydrocodone plus acetaminophen), Zocor (simvastatin), and Zestril/Prinivil (lisinopril).

Rising Sales of Generics, Declines in Brand Names

	Patent expirations of major branded drugs are peaking in the next few years, fueling continued growth in the US generic drug market. Michael Kleinrock, Director of Research Development at IMS, notes that the significant boon realized by generic companies as a result of branded patent expirations will last for a few years but then will come to an end. However, the pressures that are expected to be brought to the market by changes in the US health care law—including its effect on the Medicare and Medicaid programs&mdash;will likely keep the growth in the generic market going well into the future.

	The market analysis and research firm RNCOS Industry Research Solutions noted that despite the recession and slowdown in overall pharmaceutical spending, generics enlarged their share in the market in terms of both revenue and prescriptions. As noted in Marketwire (March 22, 2011), RNCOS predicts that the US generics market will grow at a compound annual rate of approximately 10% yearly from 2010 through 2013.

Unprecedented Patent Expirations Will Drive Generic Usage 

	Several very popular drugs became first-time generics in 2010, including the Alzheimer’s treatment Aricept (donezepil hydrochloride) and the prostate treatment Flomax (tamsulosin hydrochloride). In 2010, the FDA also approved the first generic formulation of the anticoagulant enoxaparin (Lovenox) after many years of controversy and review.

	This year the attention-deficit/ hyperactivity disorder (ADHD) treatment Concerta (extended-release methylphenidate) became available in a generic version, and the FDAapproved generic version of OrthoMcNeil-Janssen’s antibiotic Levaquin (levofloxacin) also became available. In November 2011, Pfizer’s blockbuster cholesterol therapy Lipitor (atorvastatin) loses patent protection. Eli Lilly’s antipsychotic olanzapine (Zyprexa), GlaxoSmithKline’s asthma drug Advair Diskus (fluticasone propionate), Novartis’s breast cancer treatment Femara (letrozole), and Pfizer’s glaucoma drug Xalatan (latanoprost) are each losing patent protection this year.

	The expiration of high-sales brandname drug patents will peak in 2011 and 2012, with 6 of today’s 10 largest products in the United States expected to face generic competition. Important patent expirations will continue to accrue in 2012 through 2015 in many therapeutic areas, including treatments for Alzheimer’s disease, diabetes, hypertension, cardiovascular disease, cancer, asthma, arthritis, pain, depression, schizophrenia, multiple sclerosis, and gastroesophageal reflux. By 2016, medications that currently generate $133 billion in sales for brand-name manufacturers in the United States will be facing generic competition (Table).

	“It’s fairer to say ‘How will generics affect the new health care law?’ than ‘How will the new health care law affect generics?’” said Kleinrock. “Generics will make drugs more affordable.” The evidence shows that generics offer significant cost savings: according to the Centers for Medicare & Medicaid Services (CMS), generics now account for 69% of prescriptions dispensed in Medicare, yet account for only 18% of the program’s drug spending.

	The passage of the Patient Protection and Affordable Care Act (PPACA) will itself affect generics by expanding drug coverage to as many as 32 million Americans who currently do not have health insurance. This includes 16 million people who are anticipated to obtain coverage through Medicaid, significantly increasing the number of prescriptions paid for by Medicaid.

	Aware that rates of generic dispensing are affected by pharmacy reimbursement policies, Congress addressed 2005 Deficit Reduction Act (DRA) Medicaid reimbursement formula changes that had attempted to reduce federal government payments to state Medicaid programs for generic drugs. These changes had been the subject of a court injunction, and Congress took the opportunity in the PPACA to increase the maximum level of federal government reimbursement for Medicaid generic drugs. The full impact of these changes will be determined by CMS regulations and state policies.

	The PPACA reverses some of the 2005 DRA’s proposed reductions in generic reimbursements through modifications in the definition of Average Manufacturer Price, which the new health care law uses to calculate reimbursements to pharmacies for Medicaid-dispensed drugs. It is estimated that the reimbursement formula will be between the pre-2005 rate, which has been in effect due to the injunction, and the proposed DRA rate.

	If data from a recent study conducted by the National Bureau of Economic Research on the impact of Medicaid are any indication, adding 16 million people to the program will certainly mean a greater demand for prescription drugs. The study found that previously uninsured patients were 15% more likely to use prescription medications after going on Medicaid. They were also 30% more likely to visit a doctor or clinic after they were insured by Medicaid—a factor described earlier as being directly related to prescription drug consumption. It can be expected, therefore, that demand for generic medications will rise after this provision of the new health care reform law takes effect in 2014.

	The PPACA legislation also gradually fills much of the “Doughnut Hole” coverage gap for Medicare Part D enrollees for both brand-name and generic prescription drugs. Starting in 2011 and extending through 2020, beneficiaries in the coverage gap receive gradually increasing subsidies from brand-name manufacturers and CMS, respectively, for prescription drugs and generics. In 2020, Medicare Part D beneficiaries will be responsible for only 25% of the total cost of their drugs during the coverage gap. In addition, between 2014 and 2019, the law reduces the out-of-pocket amount required to reach the catastrophic coverage threshold, reducing costs for those with relatively high prescription drug expenses. With Medicare Part D representing 30% of all prescriptions in 2010, this change may well have a significant impact on drug usage.

	The actuarial and consulting firm Milliman, Inc, has expressed concern that making the cost-share for brandname drugs the same as that for generics may discourage the use of generics because Medicare beneficiaries can hit the catastrophic limit more quickly with brand-name drugs. However, this concern has not been echoed by the Congressional Budget Office or widely reported by other analysts.

	An important issue facing the generic pharmaceutical market is the challenge to develop biosimilars, also called “biogenerics” and “follow-on biologics.”

	“Currently, the number of companies involved in marketing biosimilars is relatively low because of technical and clinical trial requirements needed for approval,” said Kleinrock, who predicts that there won’t be any biosimilars marketed in the United States until 2014.

	Given the molecular complexity of biopharmaceuticals (proteins, glycoconjugates, and antibodies), the FDA faces an enormous regulatory challenge to meet the requirements of the recently passed Biologics Price Competition and Innovation Act (BPCI) of 2009 to approve biologics as biosimilar to or interchangeable with reference products, notes an April 2011 Life Sciences Law & Industry Report. With biopharmaceuticals expected to represent 50% of the top 100 prescribed medications by 2014, this is an important area of future growth for the generic drug industry.

	Kate Kuhrt, director of generics and API intelligence at Thomson Reuters, noted that although generic manufacturers are trying to move into biosimilars, there are significant barriers to getting biosimilars to market, including the costs of developing and running clinical trials, manufacturing, and marketing. “Development costs for follow-on biologicals are estimated to be between $100 and $200 million, compared with $1 to $5 million for a typical small molecule generic drug,” she said.

	According to the Generic Pharmaceutical Association (GPhA), the investment in technology required to bring these products to market will both add to the risk and change the economics required for the industry to succeed. “Companies who compete in the biosimilar segment will need to invest in the characterization technologies, process engineering, and clinical tools needed to demonstrate the safety and efficacy of these products. This will change the face of our industry,” said GPhA board member Craig Wheeler, who is president and CEO of Momenta Pharmaceuticals.

	But steps forward in the area of biosimilars have begun. The BPCI establishes a process for the FDA to approve biosimilar versions of brandname biologic products through an abbreviated process. In a speech in April 2011 before the annual meeting of the GPhA, FDA Commissioner Margaret A. Hamburg, MD, told the group, “Under the abbreviated approval pathway that is now authorized by statute, biosimilar drugs can be legally approved due to their similarity to already approved reference products. This is a huge step forward.”

	She stated that the FDA will begin the process of engaging stakeholders to develop the first user fee program for the biosimilars industry in order to help finance needed technologies and regulatory science and research needed to deal with the complexity presented by biosimilars.

	The number of prescription drug shortages has nearly tripled over the last 6 years, according to the FDA, reaching a record high of 178 in 2010 and continuing at a rapid pace. (This figure doesn’t include vaccines, immune globulins, and other biologics.) Most of the shortages have involved generic medications, especially injectables and intravenous drugs. Medications affected by shortages have included chemotherapy drugs, antibiotics, anesthetics, succinylcholine, and nutritionals. There have also been shortages of oral medications such as those for ADHD.

	“Supply disruptions and drug shortages could become more important as some molecules do not have appropriate levels of redundancy in terms of manufacturers,” notes Kleinrock.

	The shortages are growing more severe because of quality and manufacturing problems and a lack of raw materials, as well as business decisions and industry consolidation. The FDA is supporting legislation recently introduced to require companies to notify the agency when an issue arises that can lead to shortages.

	Generic drugs are positioned for growth, largely as a result of the significant patent expirations of popular brand-name drugs over the next 5 years.

	However, while growth is anticipated to continue, uncertainties created by the new health care reform law remain, and technical and financial hurdles posed by entry into the biosimilar drug category will need to be surmounted. PT 

Jacqueline Syrop is a medical and health affairs writer based in New Jersey.

Articles

Generic Supplements

Generic Drugs: Trending Upward in Uncertain Times 

	Teva Pharmaceuticals is the leading generic drug company in the United States. Teva now represents 21% of US generic prescriptions, with 1 of every 6 US prescriptions being filled with a Teva product. Teva introduced 18 generic products in 2010, and had 188 ANDAs pending FDA approval as of June 20, 2011. The company markets the broadest product line in the country, with nearly 400 generic products in over 1200 dosage strengths and packaging sizes, covering all major therapeutic categories.

	Teva’s parent company, Teva Pharmaceutical Industries Limited, is the leading generic drug company in the world in terms of both total and new prescriptions. The company’s global presence covers North America, Europe, Latin America, Asia, and Israel, with approximately 60% of its sales generated in North America. Teva now has approximately 40,000 employees, including nearly 6000 within the United States, and annual net sales that totaled $16.1 billion in 2010. Teva operates in approximately 60 countries, including 40 finished dosage pharmaceutical manufacturing sites, 28 pharmaceutical R&D centers, and 21 active pharmaceutical ingredient (API) manufacturing sites around the world, with all pharmaceutical production facilities maintaining a uniform quality standard.

	In addition to its leadership in the generics market, Teva has a significant and growing branded pharmaceutical portfolio, including COPAXONE

 for respiratory disorders, and a sizable women’s health portfolio. The company’s wellestablished and balanced portfolio is supported by a vertically integrated API business. This vertical integration ensures that as Teva continues to grow, the company can maintain its high standard of quality and efficiency and its longstanding commitment to customer satisfaction.

	Teva has identified biopharmaceuticals—in particular, biosimilars&mdash;as an important long-term growth opportunity, and has established a dedicated research, development, and manufacturing capability. The company’s joint venture with Switzerland-based Lonza Group Ltd provides access to the expertise and infrastructure of the world’s largest producer of biological API. Teva’s biopharmaceutical R&D facilities specialize in different technologies, including the proprietary albumin fusion technology, which can be used to create longacting biological products.

Leading the Way to Affordable Health Care 

	Teva’s vision is to make quality health care accessible. The company’s Government Affairs team occupies an office on Capitol Hill and works on behalf of American consumers to advance both innovation and patient access to needed therapies. Teva also recently launched the smart-health.com Web site, where consumers can learn about generic pharmaceuticals and why they are an important element of high-quality, affordable health care. Teva is the leading provider of affordable generic medicines. Its robust pipeline of future products is a source of continuing value to American consumers. PT

	Donepezil Hydrochloride Tablets, AB rated to Aricept

Teva Pharmaceuticals: We Make Quality Health Care Accessible 

Sandoz introduced Syeda (drospirenone 3 mg/ethinyl estradiol 0.03 mg) tablets, the fourth product in a line of oral contraceptives launched by the generic drug maker this year. Equivalent to Bayer’s Yasmin, Syeda is indicated for the prevention of pregnancy in women who choose it as a method of contraception. Patients taking Syeda should be counseled not to smoke, as smoking increases the risk of serious cardiovascular side effects from oral contraceptives. Syeda is supplied in a dosage regimen identical to that of Yasmin.

 21 active tablets containing 3 mg drospirenone and 0.03 mg ethinyl estradiol; 7 inactive tablets

 Amneal Pharmaceuticals (Bridgewater, NJ)

Amneal received FDA approval to manufacture Nitrofurantoin Oral Suspension, an AB-rated, therapeutically equivalent alternative to Furadantin. Amneal is the first to market a generic version of the antibacterial medication, which is indicated for the treatment of urinary tract infection. The recommended dosage for adults is 50 to 100 mg taken 4 times daily with food. Therapy should continue for 1 week, or at least 3 days after bacteria is no longer present in the urine. Patients treated with nitrofurantoin are predisposed to persistence or reappearance of bacteriuria, and should be tested before and after completion of therapy to ensure eradication.

Roxane Laboratories, a subsidiary of Boehringer Ingelheim (Columbus, OH)

 Roxane Laboratories introduced Oxymorphone HCl tablets, an AB-rated generic version of Opana. Oxymorphone HCl tablets are a semisynthetic opioid analgesic indicated for the relief of moderate to severe acute pain when the use of an opioid is appropriate. Patients taking the medication should be advised of its potential to cause dependency, as well as its interactions with alcohol, antihistamines, and other central nervous system depressants. Roxane’s generic version is available in 100-count bottles of either 5- or 10-mg tablets.

Amlodipine Besylate and Benazepril HCl Capsules

 Lupin Pharmaceuticals, Inc (Baltimore, MD)

 Lupin Pharmaceuticals, Inc received final FDA approval on July 6, 2011, for its Amlodipine Besylate/Benazepril HCl 5-mg/40-mg and 10-mg/40-mg capsules. This approval completes the product line, as the company was granted final approval for Amlodipine/ Benazepril 2.5-mg/10-mg, 5-mg/10-mg, 5-mg/20-mg, and 10-mg/20-mg capsules in February 2010. Lupin’s Amlodipine/Benazepril capsules are the AB-rated generic equivalent of Novartis’ Lotrel capsules, and are indicated for the treatment of hypertension.

Capsules, amlodipine/benazepril: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 10 mg/20 mg, 5 mg/40 mg, and 10 mg/40 mg

 Camber Pharmaceuticals Inc (Piscataway, NJ) Compared to: Robaxin (UBC Inc)

Methocarbamol Tablets USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. Because methocarbamol may possess a general central nervous system (CNS) depressant effect, patients should be cautioned about combined effects with alcohol and other CNS depressants. Methocarbamol Tablets USP are available in 500 and 700 mg in 100-count and 500-count bottles. For the 500-mg strength, the initial adult dosage is 3 tablets 4 times daily, with a maintenance dosage of 2 tablets 4 times daily. For the 750- mg strength, the initial adult dosage is 2 tablets 4 times daily with a maintenance dosage of 1 tablet every 4 hours or 2 tablets twice daily.

Pfizer’s generic subsidiary Greenstone introduced exemestane tablets, the authorized generic of the breast cancer drug Aromasin. Exemestane is an aromatase inhibitor indicated for the treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have completed a 2-to-3-year course of tamoxifen therapy. It is also used to treat advanced breast cancer in women whose diseased progressed after undergoing treatment with tamoxifen.

Product Showcase 

Senior Vice President, Sales and Marketing, Generics Division 

	Lupin Pharmaceuticals, Inc. (LPI), a wholly owned subsidiary of Lupin Ltd., is among the top 4 pharmaceutical companies in India. With its US sales and marketing headquarters located in Baltimore, Maryland, LPI is dedicated to delivering affordable, high-quality generic medications.

	Recognized as one of the top 10 fastest growing generic manufacturers for the 3rd year in succession, LPI’s prescribing rate has grown more than 51%. LPI’s generics business is ranked 5th in total generic prescriptions dispensed, according to IMS Health’s National Prescription Audit (March 2011).

	“The US generic business is one of Lupin’s primary drivers of value creation,” said Bob Hoffman, Senior Vice President, Sales and Marketing, Generics Division. “Lupin continues to increase its market share for most of its marketed products through increased focus on execution, strong relationships with trade partners, and an efficient and responsive supply chain, all supported by a globally integrated team determined to explore better ways to create value.”

	Of the 30 generic products marketed in the United States, 14 are market leaders in terms of market share. Lupin holds the top 3 positions in 27 of these 30 generic products, and its growth is driven equally by inline as well as new product introductions. “A very lucrative product pipeline, new product launches, deep customer relationships, and world-class intellectual property capabilities have been the key to the success of our US generics business,” said Hoffman. “As the fastest growing generic player in the United States, we believe that we have the required momentum in place to accelerate this growth further. The ceiling is far from reached as we are yet to realize the true value of one of the best generic pipelines in the US market.”

	Lupin continues to invest in building up its robust pipeline of important new products. During the 2011 fiscal year, the company filed 21 Abbreviated New Drug Applications (ANDAs) with the FDA, including a record 9 that were firstto-file, and received 8 approvals. The cumulative number of ANDA filings made by Lupin now stands at 148, with 48 approvals received to date. Of these, 77 Paragraph IV filings have been made and the cumulative first-to-file opportunities for the US generics market now stands at 20. Lupin continues to maintain its position as one of the top 10 ANDA filers for the US market.

	Over the last few years, LPI has made significant investments to expand its product offerings in the United States through strategic partnerships. One major internal initiative is its imminent entry into the oral contraceptive market. Further, LPI continues to seek business development opportunities that are aligned with its strategic vision.

	Lupin’s success rests on its efficient vertically integrated business model. With consistent and continued investments in augmented manufacturing capacities, its capabilities are completely attuned to its growth aspirations. State-of-theart manufacturing plants support the delivery of quality and scale. Integration of capabilities and capacities ensures delivery of a wide product portfolio catering to the needs of diverse markets. Lupin’s manufacturing teams strive to ensure that global standards of best manufacturing practices are implemented at every Lupin facility. Lupin’s goal is to deliver the best products all the time, every time. Our customers can depend on Lupin’s vigilant compliance and assured quality for their patients’ peace of mind.

	Our reliability creates peace of mind. PT

	Lupin Now Offers Full Line of Generic Lotrel

 is a registered trademark of Novartis Corporation

Lupin's Global Integrated Team Focuses on Delivering High-Quality Generics

	In the field of pharmaceuticals, Wockhardt is gaining a reputation in several parts of the world as a name to trust. Over the past 45 years, starting from its roots in India, Wockhardt has grown to a billion dollar worldwide organization, today spanning 14 countries in 5 continents. More than 10,000 employees working in offices, 20 manufacturing facilities, 5 research centers, and hospitals are completely dedicated to building an important trust in our products.

	At Wockhardt, we draw our strength from the formidable foundation of trust built over the years through delivering quality products by continuously investing into R&D and modern manufacturing technologies, as well as contemporary processes. This enables us to deliver worldclass quality products. At Wockhardt, we don’t merely formulate medicines, we formulate trust.

	We believe that quality medicines begin with strong science and that the quality of our products is directly related to the integrity of our people. Over 525 Quality Control and Quality Assurance scientists guarantee that Wockhardt’s products and its 20 worldwide manufacturing facilities and 5 research centers meet the strict quality standards set by the FDA. Our world-class global R&D facilities are at the heart of Wockhardt’s pledge and commitment to deliver high quality medicines at affordable prices and all are fully compliant with cGMP quality standards.

	Wockhardt USA LLC is leading the way in developing the most complete, high-quality line of generic oral solids, liquids, topicals, and injectables available in the United States. Wockhardt USA now represents more than 20% of Wockhardt Ltd’s global business, providing more than 210 NDCs spanning more than 75 different product families. We have been producing and distributing quality products in the United States for more than 14 years and have received over 110 ANDA approvals to date.

	Wockhardt USA has demonstrated revenue growth of 70% for fiscal year 2010 in the world’s largest and most competitive pharmaceutical market and is geared to derive maximum value from it. With over 110 products marketed in the United States, Wockhardt USA has 13 products ranked in the No. 1 position and another 15 products in the No. 2 position in their respective therapeutic groups in the United States (Wolters Kluwer—September 2010).

	Wockhardt USA’s recent 2011 approvals include: Donepezil tablets, Levofloxacin tablets, and Venlafaxine ER capsules.

	Other key products in the Wockhardt USA product line include: Azithromycin tablets, Divaloproex ER tablets, Enalapril tablets, Metoprolol Succinate ER tablets, Nicardipine Injection, Ropinirole HCl tablets, Ceftriaxone Injection, Tamsulosin capsules, Hydrocodone and Homatropine syrup, Megestrol Acetate Oral Suspension, Nystatin Oral Suspension, and Phenytoin Oral Suspension. PT 

Wockhardt: Trusted, High-Quality Products 

	Amneal Pharmaceuticals, LLC is an American manufacturer dedicated to providing the highest quality generic drugs and exceptional service to both pharmacists and the patients under their care. Celebrating almost a decade in business, Amneal now ranks as the 8th largest generics supplier in the US market based on number of prescriptions dispensed, according to IMS Health 2010 data. All products are made in the company’s five fully cGMP-compliant, state-of-the-art manufacturing plants in the metro New York area.

Diversified Products—Simple to Sophisticated 

	Amneal now lists over 250 products approved or filed with the FDA, including controlled substances, hormonal products, high potency formulations, soft gel capsules, liquids, nasal sprays, and oral solids. The company continues to produce more mainstream, high volume drugs in a way that maximizes quality and manufacturing efficiency. At the same time, Amneal has been aggressively and successfully developing complex and niche products with high barriers-to-entry. This gives its pipeline a very balanced mix of products and creates a diverse portfolio able to address all market segments and customer needs. In addition, company acquisitions and joint ventures are focused on next-generation, technology-driven products that will drive Amneal’s strategic expansion.

	The company will enhance and further diversify its pipeline by entering new therapeutic areas and adding dosage forms such as injectables, transdermal patches, creams, and ointments. Amneal plans to introduce nearly 100 new products over the next 3 years. Extensive product information can be found in the online catalog at www.amneal.com/ products. This comprehensive resource is designed for easy pharmacist and patient access to product images, package outserts, patient medication guides, and material safety data sheets (MSDS).

	Commitment to quality—both in products and processes&mdash; infuses the entire Amneal organization. A Quality-by-Design approach builds excellence into every process. Throughout the product lifecycle, Amneal performs inspections and implements improvements from R&D, vendor selection, and manufacturing to packaging and customer support. For example, all Amneal generics feature pharmacist-defined labels designed to help reduce dispensing errors and increase efficiency in filling prescriptions. 

	Amneal has expanded and vertically integrated many lines to better control product quality and the supply chain. Manufacturing operations as well as R&D have grown significantly in Branchburg and Piscataway, New Jersey, and Brookhaven, New York. A major investment in higher volume manufacturing equipment has enabled the firm to ramp up production substantially. The company’s tablet volume alone has increased more than 400% in the last 2 years to more than 1.3 billion tablets per month. Efficient manufacturing practices combined with powerful global sourcing alliances allow Amneal to deliver a seamless supply of affordable, highest quality generic medicines with superior service levels and tremendous value to customers.

	As a result of Amneal’s relentless customer focus and delivery of superior quality generics at a fair price, the company has been recognized with 6 significant customer and industry awards in the past 2 years. The awards honor excellence across the entire organization—quality, supply, pricing, account management, customer service, leadership, innovation, and collaboration. Though this recognition is deeply gratifying, even more important is customer affirmation of Amneal’s guiding principles and ethics. Amneal team members realize success isn’t magic&mdash;it’s the result of hard work and passion for serving their valued customers. PT

	Indomethacin Extended-Release Capsules 75 mg

Amneal: Superb Quality, Award-Winning Service, and Made in the USA

	Global Pharmaceuticals is the generics division of Impax Laboratories, Inc. Impax Laboratories is a technology-based specialty pharmaceutical company and a leader in the development, manufacturing, and marketing of prescription pharmaceutical products utilizing our formulation expertise and unique drug delivery technologies.

	We are focused on targeting high-margin, first-to-file, or first-to-market product opportunities. We explore a broad range of therapeutic areas that have technically challenging drug delivery mechanisms or other niches that may result in lessened competition. We are also developing specialty generic products we believe present one or more competitive barriers to entry.

	We currently manufacture and market 93 generic pharmaceutical products, which represent dosage variations of 29 different pharmaceutical compounds through our Global Pharmaceuticals Division; another 16 of our generic pharmaceutical products representing dosage variations of 4 different pharmaceutical compounds are marketed by our alliance agreement partners.

	Our current generic pipeline has never been more valuable than it is today with more first-to-file and first-to-market opportunities either pending or under development than ever before. We currently have 36 pending ANDAs with at least 7 ANDAs having first-to-file or first-to-market potential. We are also working on an additional 62 products under development, with many having the potential to be first-to-file or first-to-market opportunities. For 2011, our internal/external goal is to file at least 12 new applications with at least 3 of these being first-to-file or first-to-market opportunities.

	Along with our parent company, Impax Laboratories, Global Pharmaceuticals continues to invest in state-of-theart equipment, people, and facilities, in order to provide the highest level of research and development, manufacturing, and customer service. Our quality assurance team works closely with our suppliers to ensure purity, consistency, and quality of products, and we strive to bring value to our customers with innovative products in key therapeutic areas.

	Global Pharmaceuticals has a dedicated team of experienced professionals handling customer orders and inquiries that work to not only meet the expectations of our customers, but consistently deliver beyond expectations. Every member of our team is committed to the success and profitability of our customers. We have set the highest standards for our products, services, and people, and we are proud of the organization we are building. PT

	Fenofibrate Tablets, 54 mg, 160 mg (90-count), and 160 mg (500-count)

	Doxycycline Capsules USP, 150 mg (60-count)

Global Pharmaceuticals: The Formulation Experts

	Committed to quality generics since 1993, Greenstone has a robust and expanding pipeline of innovator-authorized generics and ANDA generic products. Our authorized generics are manufactured under the brand NDAs. Tablets and capsules are the same size, shape, and color as the brand, and are backed with state-of-the-art distribution and customer service support of one of the world’s largest pharmaceutical companies. The expanding line of Greenstone ANDA products covers a broad range of therapeutic areas.

	Greenstone leverages decades of experience, dedicated people, and a broad product portfolio that benefits patients, pharmacists, physicians, and our partners. We are deeply committed to product quality and supply and strive to be the industry generic supplier of choice based on the ethics we uphold and the values we deliver.

	Greenstone LLC recently announced the addition of latanoprost and exemestane to its generic pharmaceutical product portfolio.

	Latanoprost is the authorized generic of, and thereby fully substitutable for, Xalatan

 (latanoprost). This generic product from Greenstone is being offered in 125 mg/2.5 mL solution, available in single count and 3-count cartons. Exemestane is the authorized generic of, and thereby fully substitutable for, Aromasin

 (exemestane). This generic product from Greenstone is being offered in 25-mg tablets, available in bottles of 30 tablets.

	Latanoprost and exemestane, which complement the growing line of products from Greenstone, are supported by a company heritage of quality, reliable manufacturing, and customer-focused attention.

	Xalatan (latanoprost) and Aromasin (exemestane) are registered trademarks of Pfizer Inc. PT

	GREENSTONE L L C Greenstone LLC recently announced the addition of latanoprost and exemestane to its generic pharmaceutical product portfolio.

Greenstone: Partner with Quality

Senior Vice President & Head—North America Generics

	At Dr. Reddy’s, we understand that every customer has a choice of products, as well as a choice of where to acquire them. Knowing this, we strive to provide quality products at the best value every day. Our ultimate goal is to provide affordable and innovative medicines for healthier lives.

	Dr. Reddy’s began marketing finished dosage form products in the United States in 2001. Today, under the Dr. Reddy’s label, 45 prescription products are marketed in 179 dosing presentations, with 25 ranked “top 3” in market share. Our Private Label OTC Group, established in 2007, markets 10 products in 200 store brand packaging presentations. We are also uniquely positioned to support Rx-to OTC switches through our OTC group.

	Vertical integration helps provide a smoother transition from manufacturing to market. Our regulatory-compliant manufacturing facilities follow cGMP guidelines in the production of finished dosage forms. Dr. Reddy’s has 4 FDA-approved finished dosage facilities servicing the United States and 8 FDA-inspected API facilities across the globe. Plans for additional dosage forms, including injectables, liquids, biologicals, and topicals, are also under way. Dr. Reddy’s has 76 ANDAs pending approval, of which 38 are Para IV certifications and 10 are FTFs. Amid changing market conditions and industry cycles, Dr. Reddy’s strives to lead the way—reining in the health care costs and improving access to medications across the United States. PT

Dr. Reddy's Laboratories--Leading the Way

	Zydus Pharmaceuticals (USA) Inc is the US generic drug division of a much larger, India-based company known as Zydus Cadila Healthcare. Zydus Cadila is a global, fully integrated pharmaceutical company with a presence in 50 countries and is committed to growing its presence around the world and in the United States.

	Zydus Cadila has been achieving this goal both through acquisitions and organic growth. Globally, over the last 6 years, it has acquired companies in France, Japan, Brazil, Spain, and South Africa. There is also acquisition activity occurring within the United States. Throughout the world, Zydus is focused on providing outstanding customer service, along with high-quality, affordable products. Its vision is to be a leading global health care provider with a robust pipeline and sales over $3 billion by 2015.

	While Zydus Cadila continues to focus on the domestic market in India, it is growing rapidly in key regulated global generic markets, such as the United States, Europe, and Latin America. As the 4th largest pharmaceutical company in India, Zydus is well positioned to meet the needs of today’s generic pharmaceutical marketplace and is forging relationships as a strategic contract manufacturer. What sets the company apart is a never-ending commitment to innovation and building a strong product pipeline, with a focus on products that will deliver the most value to the company as well as customers.

	Zydus Cadila takes pride in its manufacturing and development history, which spans more than 50 years. Its FDAapproved Moraiya plant is India’s largest finished dosage plant under one roof, with a total space of 40 acres. Its modular design allows for rapid expansion to add capacity and meet the ever-growing global demand for generic pharmaceutical products. The breadth of the company’s product form capability—tablets, hard and soft gelatin capsules, parenterals, metered dose inhalers, and transdermal patches&mdash;sets it up to be “The Global Sourcing Partner of Choice” in the generic pharmaceutical industry.

	Three technology centers—the Zydus Research Center, the Pharmaceutical Technology Center, and Active Pharmaceutical Ingredient (API) Process Research&mdash;all work together to develop the best quality products now and for the future. Zydus is also one of India’s largest API manufacturers, with 2 of its facilities FDA-approved and supporting many of its generic formulations.

	Chief Executive Officer of the US division, Joe Renner, envisions a US generic marketplace where manufacturers and customers come together in the sourcing of generic products earlier on in the continuum of product management, in order to maximize the risk—reward profiles and deliver maximum value to all parties involved. With major support from its parent company, Zydus Pharmaceuticals (USA) Inc. continues to grow by delivering products to the US marketplace. To date, the company has filed 91 drug master files, received 67 Abbreviated New Drug Application (ANDA) final and tentative approvals, and has 46 ANDAs pending approval with the FDA.

	With now over 223 SKUs commercially available, Zydus continues to grow within the US marketplace. In fact, Zydus, for the 6th straight year, has been named by IMS Health as one of the fastest-growing pharmaceutical companies. IMS Health also listed Zydus in the top 20 (#12) US Generic Companies based upon total prescriptions dispensed.

	Zydus’ success to date is predicated upon its outstanding customer service, expanding generic portfolio, and dedication to being vertically integrated on many finished dosage forms. Its very strong US management team has more than 100 years of combined experience in the US generic marketplace.

	Recent company achievements include: reaching $1 billion in revenue worldwide, along with the launches of potassium chloride 10mEq ER tabs and generic venlafaxine XR, bioequivalent to Pfizer’s Effexor XR.

 You can visit Zydus at their booth (location number 1120) or learn more about Zydus Pharmaceuticals through their Web site, 

	Zydus is poised to continue its tremendous growth, with its low-cost production, R&D/legal/regulatory capabilities for product development, and, most importantly, customer focus. Clearly, Zydus Cadila and its worldwide divisions are setting themselves up to be known as “The Global Sourcing Partner of Choice.” PT  

The Global Sourcing Partner of Choice--Zydus Cadila Healthcare & Zydus Pharmaceuticals (USA) Inc

	In a highly competitive industry that faces continued challenges, Hi-Tech Pharmacal remains the rock-solid source of quality products it has been for the last 3 decades.

	An established US-based company that prides itself on being customer-focused, Hi-Tech Pharmacal reported record sales for the year ending April 30, 2011. David Seltzer, President and CEO, commented, “We are very pleased with results for fiscal year end as we reported the best results in the Company’s history. Our generic version of Flonase®, in particular, was an outstanding success, and we continue to gain market share. Our pipeline of products has never been stronger.”

	Hi-Tech has the expertise necessary to develop and manufacture liquid and semi-solid dosage forms—such as Fluticasone Propionate, generic for Flonase®&mdash;including products that require sterile manufacturing.

	Currently, 13 Hi-Tech products have been submitted to the FDA pending approval, and approximately 20 products are in various stages of development. The company is continually expanding its range of products, dosage forms, and packaging configurations.

	Hi-Tech recently acquired the marketing and distribution rights to several unique branded products for the treatment of pain from Atley Pharmaceuticals. The products will be distributed through ECR Pharmaceuticals, a subsidiary of Hi-Tech Pharmacal. ECR’s line already includes branded prescription products for the treatment of allergies, headaches, and dermatitis/poison ivy.

	Thus far in calendar year 2011, Hi-Tech has received final approval for Levofloxacin Ophthalmic Solution, Gabapentin Oral Solution (under 180-day exclusivity), Lidocaine Jelly 2%, Ranitidine Syrup, and Levofloxacin Oral Solution (also under 180-day exclusivity). Levofloxacin Oral Solution is the generic for Levaquin® Oral Solution, which generated annual sales of approximately $6 million.

	The FDA has granted Hi-Tech tentative approval for the generic for Allergan’s Combigan® ophthalmic solution, which had sales of $108 million in 2010. Hi-Tech plans to launch the product after the company receives final approval from the FDA.

	With more than 20 projects currently in development, Hi-Tech maintains an ongoing commitment to an ambitious R&D program. Hi-Tech is currently developing drugs with total branded sales of over $4 billion, including sterile ophthalmic products, oral solutions and suspensions, and solid dosage forms, which will bring a broad range of opportunities to its pharmacy partners over the next several years.

	“We’re committed to finding ways to deliver value at Hi-Tech,” notes Seltzer. “We’re driven by the same core values we established when the company was founded in 1981—focus, innovation, confidence, and trust.” Seltzer exhibits the confidence that comes with success. “We remain very optimistic about our future,” he says. “We see tremendous opportunity ahead of us as our generics pipeline is more robust than ever.”

	For his part, Hi-Tech Vice President of Sales and Marketing, Ed Berrios, points out that “Expanding our portfolio of key and niche products adds another level of value for our customers.”

	“Every new product is another opportunity to make strong partnerships even stronger,” Berrios says. “Our pharmacy partners are an integral part of our success, and we’re committed to providing even greater value in the future. That’s why we continue to invest in Research and Development— more than doubling our spending on R&D over the last 5 years.” PT

	Levofloxacin Oral Solution 25 mg/mL is now available in multiple sizes—480 mL, 200 mL, and 100 mL.

Hi-Tech Pharmacal: A Solid Source of Quality 

President and Chief Executive Officer, Nycomed US Inc. 

Senior Vice President/General Manager, Fougera

 is the leading specialty pharmaceutical manufacturer and provider of high quality topical products. An eminent generics company since the advent of the industry in the 1960s, Fougera remains a principal player due to its forward-thinking technology and innovation, as well as its pipeline. Fougera credits its “Make No Compromises

” philosophy as the backbone of its success.

	Fougera’s FDA approval of its Adapalene Cream 0.1% (Rx) included a rating of AB as generically equivalent to Differin

(Galderma) and indicated for the treatment of acne vulgaris.

	Fougera’s FDA approval of its Imiquimod Cream 5% (Rx) included a rating of AB as generically equivalent to Aldara

 (Graceway Pharmaceuticals). The product is available in single use foilpacs

, Fougera’s proprietary packaging innovation. “Fougera continues to develop cost-effective, safe, and effective generic treatment options for healthcare providers and patients. Receiving the first generic approval for Imiquimod Cream demonstrates our capabilities and commitment,” said David Klaum, Senior Vice President and General Manager. Fougera continues to receive topical FDA approvals—more than any other topical generic company&mdash;including a wide range of creams, ointments, gels, lotions, and solutions.

	Founded by pharmacist Edmond Fougera in 1849, Fougera has a long tradition of serving pharmacists and healthcare providers. A wider audience of wholesalers and distributors, hospital, chain, and community pharmacy, medical, surgical, managed care, government, and export markets all rely on Fougera. The company prides itself on delivering on its promise to meet customer needs and anticipate emerging ones.

	Over 10,000 FDA-approved generic drugs are available. The IMS Institute for Healthcare Informatics report, titled 

The Use of Medicines in the United States Review 

of 2010, observed that generics fill 78% of all prescriptions dispensed in the Unites States, 4% higher than 2009. Fougera is proud to contribute to the role that generic manufacturers play in providing high quality, safe and effective treatments that reduce cost for consumers and the healthcare system.

The Fougera Organization and Its Pipeline 

	Fougera is the leading manufacturer and distributor of a wide range of topical products. With the establishment of our sister division PharmaDerm

 in 2002, a specialty pharmaceutical company dedicated to developing and commercializing prescription products to treat diseases and conditions of the skin such as Solaraze

, we cover the overall scope for topical dermatology. From product conception, through design and quality manufacturing, to high quality service to our customers, all of our divisions work endlessly to ensure that we do the best to introduce and maintain the proper lifecycle for our complete product portfolio. Fougera is steadfast in its mission to deliver with its “Make No Compromises

Imiquimod Cream 5% (Rx) is available in single-use foilpacs

Fougera: Topical Generics Leader 

	Getting pharmaceutical products to market is hard enough. Challenges such as active pharmaceutical ingredient (API), formulation, drug delivery technologies, and manufacturing difficulties can make the task seem even more insurmountable. KREMERS URBAN Pharmaceuticals is a company that delivers the product solutions and dedicated customer service needed to get specialty generic products to market without all the perplexity.

Providing Leadership Through the Drug Development Maze 

	Many promising drugs are abandoned early because of difficult-to-synthesize ingredients, complicated formulations, manufacturing issues, or legal challenges. KREMERS URBAN Pharmaceuticals, a subsidiary of Belgium-based UCB, strives to deliver the tough solutions and reliable service that get products to market. The Company’s focus is providing a wide array of generic pharmaceuticals — particularly those products with difficult-to-produce or limited-supply APIs or finished goods formulations, dedicated containment facilities, or Paragraph IV challenges &mdash; and biosimilar products. It is a strategy that is achieved through a combination of internal development and strategic partnerships.

	The vision of KREMERS URBAN is to be a premier specialty generic pharmaceutical company with a portfolio of high-barrier-to-entry products and limited competition. Leveraging the vast resources of its parent company, KREMERS URBAN is moving to the forefront of delivering the tough solutions necessary to get complex products into the market. Its professionals are experts at increasing efficiencies and reducing the cost of getting generic products to the appropriate market segments.

	The newest products in the KREMERS URBAN portfolio are Hydrocodone Polistirex and Chlorpheniramine Polistirex Pennkinetic

 Extended-Release Suspension CIII (authorized generic for Tussionex

 Extended-Release Suspension CIII) and Pantoprazole Sodium Delayed-Release Tablets. Other KREMERS URBAN extended-release products that require complex drug development technology and manufacturing process include Oxybutynin Chloride Extended-Release Tablets USP, Omeprazole Delayed-Release Capsules, Nifedipine Extended-Release Tablets USP, Verapamil Hydrochloride Extended-Release Capsules, and several other extendedrelease and transdermal generic products. The Company stands behind each of its products, ensuring the highest standards available.

	In addition to aggressively pursuing in-licensing generic drug products and internal research and development, KREMERS URBAN looks to expand its generic product portfolio by leveraging the biopharmaceutical capabilities being developed by UCB. KREMERS URBAN also seeks strategic alliances in the development of products and drug delivery technologies that would further enhance its capabilities or offerings.

A History of Solving Our Customers’ Toughest Problems 

	The history of KREMERS URBAN dates back more than a century. It was acquired by SCHWARZ PHARMA Manufacturing, Inc. in the mid-90s before SCHWARZ PHARMA Manufacturing, Inc. was acquired by UCB in 2006. KREMERS URBAN has made impressive strides since it embarked on its own. The business continues to excel in its service and capabilities. Fill rates, lead times, and service levels consistently attain 100%, meeting or exceeding all of its customers’ expectations. All this translates to major corporate growth and more extensive capabilities. Along with commercial offices in Princeton, New Jersey, it relocated its dedicated customer service headquarters to Seymour, Indiana, where it has also invested in an impressive 400,000-square-foot pharmaceutical manufacturing plant. With its dedicated facilities, comprehensive infrastructure, technical expertise, and UCB corporate support, KREMERS URBAN is uniquely structured and positioned to manage high barriers to entry.

	Whether it’s complex APIs, drug delivery systems, or challenging product formulations, you can trust its professionals to complete the complicated puzzle of market entry, and KREMERS URBAN to master the complexities of the marketplace. PT  

A sampling from the KREMERS URBAN portfolio. 

Mastering the Complexities of the Market 

	At Actavis, the products may be “generic,” but the way the company goes about developing, manufacturing, and marketing them is anything but.

	In 1999, Actavis was in a single country, its home of Iceland, with fewer than 150 employees. In a matter of just a decade, with aggressive product development and the acquisition and successful integration of more than 25 companies across the globe, Actavis is now among the top 5 leading developers of generic pharmaceuticals in the world. All in all, the company has approximately 850 products on the market globally, with nearly 330 more in active development.

	Actavis has one of the broadest product portfolios and strongest pipelines in the business, with products that cover the full gamut of dosage forms, including tablets, capsules, injectables, suppositories, powders, oral liquids, and semisolids. Diverse? Yes. But there’s one common element to them all: helping make pharmaceuticals more affordable for consumers.

A Goal Accomplished Through a Winning Strategy 

	Growth of more than 2600% in 10 years doesn’t come easy. But from its beginnings, Actavis has been well managed and aggressive. Actavis focuses on its customers and on providing high-quality, lower-cost products—with a strong pipeline of new products and a team that is committed to bringing those products to market.

	The company of more than 10,000 works tirelessly to bring a wide range of high-quality generics to market and it keeps costs under control through continuous process improvement, resource optimization, and ongoing, careful analysis. It’s a formula that has helped propel Actavis to a leading position in markets across the world.

	After this intense period of growth, the company now has a solid foundation on which to build. Actavis is investing strongly in and growing its research and development capability. It is expanding its growing portfolio and dosage forms and enhancing its quality systems and production processes in its plants. And it anticipates launching numerous ANDAs this year, with many more to come.

	For Actavis, it’s been a fascinating, fast-paced journey from a small Icelandic company to an international organization, but it’s one that was founded on the right idea: offering high-quality, affordable alternatives to brand name drugs.

	• A leading developer and manufacturer of high-quality generics.

	• Actavis has the world’s only pharmaceutical manufacturing facility completely powered by geothermal energy.

	• More than 10,500 employees in 40 countries (including more than 1100 in the United States).

	• Approximately 850 products on the market and 330 more on the way.

	• Twenty-four billion tablet and capsule capacity.

	• The name Actavis comes from 2 Latin words: acta, meaning action; and vis, meaning strength. PT 

	Actavis proudly launched Oxymorphone Hydrochloride ExtendedRelease Tablets, CII, in 7.5-mg and 15-mg strengths. It is AB rated to Opana

 * ER (oxymorphone hydrochloride) Extended-Release tablets. For Full Prescribing Information and other Important Safety Information, please visit 

	At Actavis, we are working to meet the demand for high quality lower-cost alternatives to brand name pharmaceuticals.

 is a registered trademark of a party other than Actavis.

Generic Supplement 2011