Blockbuster Drugs Facing Patent Expiration in 2016

Several high-profile, brand-name drugs with various therapeutic applications are slated to lose their patent protection this year.

Several high-profile, brand-name drugs with various therapeutic applications are slated to lose their patent protection this year.

Patent expirations for highly prescribed brand-name drugs will continue to influence health care spending as lower-cost generics are allowed to compete in the pharmaceutical marketplace and drive down costs.

Although it depends on the type of treatment, the average price of a generic can be as much as 80% to 85% lower than its patented brand-name counterpart.

Organized by therapeutic area, the following drugs are slated to lose their patent protection this year:

High Blood Pressure, High Cholesterol, and Heart Disease

The total estimated annual revenue for the following 3 drugs is $11.6 billion.

Crestor

AstraZeneca’s Crestor (rosuvastatin calcium) received FDA approval in 2007 as an adjunct to diet to slow the progression of atherosclerosis in patients with elevated cholesterol.

As of August 2015, Crestor was the top-prescribed brand-name drug in 2015, with 21 million prescriptions written by that time.

In June 2015, the FDA recommended approval for Amgen’s potential Crestor rival, Repatha.

Benicar

Daiichi Sankyo’s Benicar (olmesartan medoxomil) received expanded approval in 2010 to treat the growing number of children with hypertension, which reached 3.6 million in 2015.

Hypertension treatment recommendations have undergone significant changes in recent times, especially following the latest Joint National Committee guidelines.

Zetia

At the time of its approval, Merck’s Zetia (ezetimibe) was the first agent in a new class of drugs to treat high cholesterol in patients whose cholesterol remained uncontrolled despite achieving a ceiling statin dose.

Mental Health

Nuvigil

Teva’s Nuvigil (armodafinil) is indicated to treat sleepiness related to narcolepsy, sleep apnea, or night-shift work.

Teva attempted to have Nuvigil approved as an antidepressant, but the FDA refused to grant this expanded approval even after several phase 3 trials.

Intuniv

Shire’s Intuniv (guanfacine hydrochloride extended-release tablets) is a mainstay treatment for childhood attention-deficit/hyperactivity disorder, which is estimated to affect 1 in 10 US children.

Shire has licensing agreements with several manufacturers that allowed 4 generic versions of Intuniv to hit the market in June 2015.

Notably, Intuniv was cut from CVS’s formulary for 2016.

Seroquel XR

AstraZeneca’s Seroquel XR (quetiapine fumarate) was approved in 2009 for the acute treatment of depressive episodes associated with acute, manic, and mixed episodes of bipolar disorder.

HIV

Epzicom and Trizivir

GlaxoSmithKline and ViiV Healthcare’s Epzicom (abacavir and lamivudine) and Trizivir (abacavir sulfate, lamivudine, and zidovudine) are both fixed-dose, combination treatments for adults with HIV.

Both drugs are classified as nucleoside reverse transcriptase inhibitors, which work to create defunct HIV DNA strands.

Norvir and Kaletra

Abbott Laboratories’ Norvir (ritonavir) and Kaletra (lopinavir and ritonavir) are both protease inhibitors indicated to treat HIV. Protease inhibitors are normally used in patients who fail a prior treatment regimen, and they function by preventing the enzyme protease from cleaving HIV DNA proteins into new HIV virions.

In 2009, the FDA issued a warning letter against Abbott’s direct-to-consumer video for Kaletra that featured Magic Johnson. According to the letter, the video “minimize[d] the serious risks” and “overstate[d] the efficacy” of the drug.