semaglutide · Novo · NDA 215256, 218316
Wegovy
Earliest generic entry, as listed · earliest of 14 marketed strengths
1 Feb 2039
Other strengths are listed to 17 Feb 2041.
Blocked by patent: US 11833248, US 12396953.
Listed patents · 19 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11318191 | product, use U-3162 | 17 Feb 2041 |
| US 11318191 | product, use U-4443 | 17 Feb 2041 |
| US 11318191 | product, use U-4560 | 17 Feb 2041 |
| US 11478533 | use U-3861 | 13 May 2040 |
| US 11833248 | product, use U-4387 | 1 Feb 2039 |
| US 12396953 | product, use U-4387 | 1 Feb 2039 |
| US 12029779 | use U-3162 | 10 Oct 2038 |
| US 12551536 | use U-4418 | 10 Oct 2038 |
| US 10888605 | product, use U-3162 | 24 Aug 2038 |
| US 11752198 | product, use U-3162 | 24 Aug 2038 |
| US 12214017 | product, use U-3162 | 24 Aug 2038 |
| US 12569543 | use U-4443 | 28 Apr 2037 |
| US 10278923 | use U-4389 | 2 May 2034 |
| US 12239739 | use U-4388 | 2 May 2034 |
| US 9764003 | use U-3161 | 21 Jun 2033 |
| US 11033499 | product, use U-4496 | 19 Jun 2033 |
| US 11382957 | product | 16 Dec 2031 |
| US 9278123 | product, use U-4389 | 16 Dec 2031 |
| US 8129343 | substance, product | 5 Dec 2031 |
Exclusivities · 3 unexpired
| NP | new product | 22 Dec 2028 |
| I-973 | new indication (3 years) | 15 Aug 2028 |
| I-935 | new indication (3 years) | 8 Mar 2027 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 14
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215256 · 001 · RLD | solution, subcutaneous | 0.25MG/0.5ML (0.25MG/0.5ML) | 17 Feb 2041 |
| 215256 · 002 · RLD | solution, subcutaneous | 0.5MG/0.5ML (0.5MG/0.5ML) | 17 Feb 2041 |
| 215256 · 003 · RLD | solution, subcutaneous | 1MG/0.5ML (1MG/0.5ML) | 17 Feb 2041 |
| 215256 · 004 · RLD | solution, subcutaneous | 1.7MG/0.75ML (1.7MG/0.75ML) | 17 Feb 2041 |
| 215256 · 005 · RLD | solution, subcutaneous | 2.4MG/0.75ML (2.4MG/0.75ML) | 17 Feb 2041 |
| 215256 · 007 · RLD | solution, subcutaneous | 0.25MG/0.5ML (0.25MG/0.5ML) | 17 Feb 2041 |
| 215256 · 008 · RLD | solution, subcutaneous | 0.5MG/0.5ML (0.5MG/0.5ML) | 17 Feb 2041 |
| 215256 · 009 · RLD | solution, subcutaneous | 1MG/0.5ML (1MG/0.5ML) | 17 Feb 2041 |
| 215256 · 010 · RLD | solution, subcutaneous | 1.7MG/0.75ML (1.7MG/0.75ML) | 17 Feb 2041 |
| 215256 · 011 · RLD | solution, subcutaneous | 2.4MG/0.75ML (2.4MG/0.75ML) | 17 Feb 2041 |
| 218316 · 001 · RLD | tablet, oral | 1.5MG | 1 Feb 2039 |
| 218316 · 002 · RLD | tablet, oral | 4MG | 1 Feb 2039 |
| 218316 · 003 · RLD | tablet, oral | 9MG | 1 Feb 2039 |
| 218316 · 004 · RLD | tablet, oral | 25MG | 1 Feb 2039 |
Expired or delisted (2)
- US 8536122 · substance, product · 20 Mar 2026
- D-190 · 21 Jul 2026