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.
