Which drugs go off patent in 2028?
Seven blockbuster drugs with $73.1B in 2025 worldwide sales lose US exclusivity in 2028, led by Keytruda (Merck, $31.7B). Four are small-molecule drugs that go generic, two are biologics that face biosimilars and one is a vaccine.
| Drug | Company | Area | 2025 sales | Date basis | US copies | Medicare price |
|---|---|---|---|---|---|---|
| Keytruda | Merck | Oncology | $31.7B | Company guidance | In clinical trials | – |
| Eliquis | Bristol Myers Squibb / Pfizer | Cardiometabolic | $14.4B | Settlement / court date | Approved, waiting to launch | 2026 · −56% |
| Opdivo | Bristol Myers Squibb | Oncology | $10.1B | Company guidance | Filed with the FDA | – |
| Vyndaqel | Pfizer | Cardiometabolic | $6.4B | Patent-expiry estimate | Filed with the FDA | – |
| Gardasil | Merck | Vaccines | $5.2B | Patent-expiry estimate | No US filing found | – |
| Jakafi | Incyte | Oncology | $3.1B | Company guidance | Filed with the FDA | – |
| Otezla | Amgen | Immunology | $2.3B | Settlement / court date | Approved, waiting to launch | 2027 · −65% |
Five of these dates are fixed by a launch, settlement, court ruling or company guidance; two are estimates from patent expiry and could move. Each drug's page has the sources.
| Company | Drugs | 2025 revenue from them | Share of company |
|---|---|---|---|
| Merck | Keytruda and Gardasil | $36.9B | 57% |
| Bristol Myers Squibb | Eliquis and Opdivo | $24.5B | 51% |
| Pfizer | Eliquis and Vyndaqel | $14.3B | 23% |
| Incyte | Jakafi | $3.1B | 60% |
| Amgen | Otezla | $2.3B | 6.2% |
For shared drugs, each company is credited with the revenue it reports, so nothing is counted twice. Share is of the company's total 2025 revenue.
Generic launches usually take most of a drug's US volume within months. Biosimilars usually erode a biologic's sales more gradually, because they are harder to make and switching takes longer. Vaccines are hard to copy, so competition after exclusivity ends usually arrives slowly. Eliquis and Otezla were also selected for Medicare price negotiation, which can cut Medicare revenue before or alongside US copies.
US exclusivity can end earlier or later than these dates if a court ruling, settlement or new patent changes the picture. See what happened to sales after past patent cliffs →