October Generic Product News

Pharmacy TimesOctober 2022
Volume 88
Issue 10

In this month's generic products roundup, Cipla and Lupin have expanded with new products.

Lenalidomide Capsules

Marketed by Cipla

Compare To: Revlimid

The FDA approved Cipla’s abbreviated new drug application for lenalidomide capsules in 4 dosages: 5 mg, 10 mg, 15 mg, and 25 mg. The capsules are the generic version of Revlimid (Bristol Myers Squibb). The immunomodulatory prescription drug can be used as monotherapy for adults with hematological malignancies and can be combined with first-line or maintenance treatment or in the relapsed setting. Lenalidomide is indicated to treat cancer types such as follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, multiple myeloma, and myelodysplastic syndrome. Lenalidomide should not be prescribed to children or pregnant women, and cannot be used in treating patients with chronic lymphocytic leukemia.

For More Information: cipla.com

Diclofenac Sodium Topical Solution USP 2%

Marketed by Lupin

Compare To: Pennsaid Topical Solution 2%

The FDA has approved Lupin’s abbreviated new drug application for diclofenac sodium topical solution USP 2%, which is the generic equivalent of Pennsaid topical solution 2% from Horizon Therapeutics. Pennsaid is a nonsteroidal anti-inflammatory drug indicated for the treatment of signs and symptoms of osteoarthritis in the knees, according to the FDA. The most common adverse reaction investigators saw for Pennsaid was application site reaction. The generic version of the drug has estimated annual sales of $484 million in the United States, according to the company.

For More Information: lupin.com

Rifaximin 200-mg Tablets

Marketed by Norwich Pharmaceuticals

Compare To: Xifaxan

Rifaximin 200-mg tablets, indicated to treat travelers’ diarrhea, has received tentative approval from the FDA. Rifaximin is not expected to hit US markets until July 2029, because a patent for the reference product, Xifaxan from Bausch Health Cos, does not expire until then. Alvogen’s Norwich Pharmaceuticals, which filed for an abbreviated new drug application from the FDA for the generic diarrhea tablets, is not expected to market the product until the original patent expires.

For More Information: alvogen.com

Adapalene and benzoyl peroxide topical gel 0.3%/2.5%

Marketed by Alembic Pharmaceuticals

Compare To: Epiduo Forte

The FDA approved a new drug application for adapalene and benzoyl peroxide topical gel 0.3%/2.5%. The topical treatment is indicated to treat acne vulgaris in patients 12 years and older. The reference product is Epiduo Forte topical gel, which was developed by Galderma Laboratories. Adapalene and benzoyl peroxide topical gel 0.3%/2.5% had an estimated market size of $211 million in March 2022, according to Alembic Pharmaceuticals.

For More Information: alembicpharmaceuticals.com

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