semaglutide · Novo · NDA 209637, 213051
Ozempic
Earliest generic entry, as listed · earliest of 9 marketed strengths
10 Oct 2038
Other strengths are listed to 17 Feb 2041.
Blocked by patent: US 12295988, US 12295988. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 22 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11318191 | product, use U-1852 | 17 Feb 2041 |
| US 11318191 | product, use U-4561 | 17 Feb 2041 |
| US 11833248 | product, use U-2628 | 1 Feb 2039 |
| US 12396953 | product, use U-2628 | 1 Feb 2039 |
| US 12295988 | use U-1852 | 10 Oct 2038 |
| US 12295988 | use U-2628 | 10 Oct 2038 |
| US 10888605 | product, use U-1852 | 24 Aug 2038 |
| US 11752198 | product, use U-1852 | 24 Aug 2038 |
| US 12214017 | product, use U-1852 | 24 Aug 2038 |
| US 12569543 | use U-4446 | 28 Apr 2037 |
| US 10278923 | substance, product, use U-2628 | 2 May 2034 |
| US 12239739 | substance, product, use U-2628 | 2 May 2034 |
| US 12514822 | use U-2628 | 2 May 2034 |
| US 10335462 | use U-2580 | 21 Jun 2033 |
| US 10335462 | use U-1852 | 21 Jun 2033 |
| US 11033499 | product, use U-2628 | 19 Jun 2033 |
| US 11382957 | substance, product | 16 Dec 2031 |
| US 9278123 | substance, product, use U-2628 | 16 Dec 2031 |
| US 8129343 | substance, product, use U-2202 | 5 Dec 2031 |
| US 8129343 | substance, product, use U-2628 | 5 Dec 2031 |
| US 8129343 | substance, product, use U-3355 | 5 Dec 2031 |
| US 8129343 | substance, product, use U-3469 | 5 Dec 2031 |
Exclusivities · 2 unexpired
| I-976 | new indication (3 years) | 17 Oct 2028 |
| I-961 | new indication (3 years) | 28 Jan 2028 |
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 · 10
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 209637 · 001 · RLD · discontinued | solution, subcutaneous | 2MG/1.5ML (1.34MG/ML) | 21 Jun 2033 |
| 209637 · 002 · RLD | solution, subcutaneous | 4MG/3ML (1.34MG/ML) | 10 Oct 2038 |
| 209637 · 003 · RLD | solution, subcutaneous | 8MG/3ML (2.68MG/ML) | 10 Oct 2038 |
| 209637 · 004 · RLD | solution, subcutaneous | 2MG/3ML (0.68MG/ML) | 10 Oct 2038 |
| 209637 · 005 · RLD | solution, subcutaneous | 0.25MG/0.5ML (0.25MG/0.5ML) | 17 Feb 2041 |
| 209637 · 006 · RLD | solution, subcutaneous | 0.5MG/0.5ML (0.5MG/0.5ML) | 17 Feb 2041 |
| 209637 · 007 · RLD | solution, subcutaneous | 1MG/0.5ML (1MG/0.5ML) | 17 Feb 2041 |
| 213051 · 004 · RLD | tablet, oral | 1.5MG | 1 Feb 2039 |
| 213051 · 005 · RLD | tablet, oral | 4MG | 1 Feb 2039 |
| 213051 · 006 · RLD | tablet, oral | 9MG | 1 Feb 2039 |
Expired or delisted (17)
- US 9132239 · product · 1 Feb 2032 · delisted
- US 9457154 · product · 29 Sep 2027 · delisted
- US 9687611 · product · 27 Feb 2027 · delisted
- US RE46363 · product · 3 Aug 2026 · delisted
- US 10220155 · product · 17 Jul 2026 · delisted
- US 11097063 · product · 17 Jul 2026 · delisted
- US 8920383 · product · 17 Jul 2026 · delisted
- US 9775953 · product · 17 Jul 2026 · delisted
- US 8536122 · substance, product, use U-3355 · 20 Mar 2026
- US 8536122 · substance, product, use U-2628 · 20 Mar 2026
- US 8536122 · substance, product, use U-2202 · 20 Mar 2026
- US 8536122 · substance, product, use U-3469 · 20 Mar 2026
- US 10357616 · product · 20 Jan 2026 · delisted
- US 10376652 · product · 20 Jan 2026 · delisted
- US 9108002 · product · 20 Jan 2026 · delisted
- US 9616180 · product · 20 Jan 2026 · delisted
- US 9861757 · product · 20 Jan 2026 · delisted