Which drugs go off patent in 2031?
Eight blockbuster drugs with $48.8B in 2025 worldwide sales lose US exclusivity in 2031, led by Dupixent (Sanofi / Regeneron, $17.8B). Four are small-molecule drugs that go generic and four are biologics that face biosimilars.
| Drug | Company | Area | 2025 sales | Date basis | US copies | Medicare price |
|---|---|---|---|---|---|---|
| Dupixent | Sanofi / Regeneron | Immunology | $17.8B | Company guidance | In clinical trials | – |
| Imfinzi | AstraZeneca | Oncology | $6.1B | Company guidance | Early development | – |
| Verzenio | Eli Lilly | Oncology | $5.7B | Company guidance | No US filing found | 2028 · pending |
| Tremfya | Johnson & Johnson | Immunology | $5.2B | Company guidance | In clinical trials | – |
| Kisqali | Novartis | Oncology | $4.8B | Company guidance | No US filing found | 2028 · pending |
| Kesimpta | Novartis | Neuroscience | $4.4B | Company guidance | Early development | – |
| Descovy | Gilead | Infectious disease | $2.8B | Company guidance | Approved, waiting to launch | – |
| Cabometyx | Exelixis | Oncology | $2.1B | Settlement / court date | Approved, waiting to launch | – |
Every date here is fixed by a launch, settlement, court ruling or company guidance. Each drug's page has the sources.
| Company | Drugs | 2025 revenue from them | Share of company |
|---|---|---|---|
| Sanofi | Dupixent | ≈$17.8B | 36% |
| Novartis | Kisqali and Kesimpta | $9.2B | 17% |
| AstraZeneca | Imfinzi | $6.1B | 10% |
| Eli Lilly | Verzenio | $5.7B | 8.8% |
| Regeneron | Dupixent | $5.2B | 37% |
| Johnson & Johnson | Tremfya | $5.2B | 5.5% |
| Gilead | Descovy | $2.8B | 9.4% |
| Exelixis | Cabometyx | $2.1B | 91% |
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. Verzenio and Kisqali 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 →