Drugs Going Off Patent in 2021

Between 2011 – 2016, the pharmaceutical industry experienced the first “patent cliff.” Over this five-year period, hundreds of billions of big pharma company sales lost patent protection. While 2021 doesn’t have near the impact of a “patent cliff” year, there are still some anticipated patent expirations that will make an impact in 2021.

Following are drugs expected to lose patent protection in 2021:

Brand Generic Use Anticipated Release Backup Utilization*
Amitiza lubiprostone Constipation RJan 2021 Yes
Sutent sunitinib Kidney cancer Feb 2021 No
Tarceva erlotinib Lung & pancreatic cancer May 2021 No
Perforomist formoterol Asthma & COPD Jun 2021 Yes
Brilinta ticagrelor Heart attack & stroke Jul 2021 Yes
Selzentry maraviroc HIV Aug 2021 No
Atripla efavirenz / emtricitabine / tenofovir HIV Sep 2021 Yes
Bystolic nebivolol High blood pressure Sep 2021 Yes
Truvada emtricitabine / tenofovir HIV Sep 2021 Yes
Brovana arformoterol Asthma & COPD Sep 2021 Yes
Pradaxa dabigatran Atrial fibrillation Sep 2021 Yes

Source: GoodRx.com

The MedCallRx business analysis team compared the list of drugs coming off patent against current backup utilization. During the three-month period of 8/1/2020 – 10/31/2020, 8 of the 11 drugs were sent to a backup pharmacy partner, though overall utilization was low:

Drug Annualized # of Prescriptions
Atripla 20
Truvada 44
Perforomist 56
Brovana 84
Bystolic 180
Amitiza 180
Pradaxa 192
Brilinta 324

The practice of protecting drugs with patents dates back to the 17th century in England – long before standards were put in place to measure safety or efficacy. Currently, U.S. patents for medications typically last for 20 years but the patent takes effect immediately – even prior to the FDA approving the drug. This effectively reduces the 20-year period of exclusivity from anywhere from 8-16 years. MedCall will continue to monitor the drug pipeline for emerging medications as well as those losing patent protection to keep clients informed.