semaglutide · Novo · NDA 213051
Rybelsus
Earliest generic entry, as listed · earliest of 3 marketed strengths
2 May 2034
Blocked by patent: US 10278923, US 12239739, US 12514822.
Listed patents · 14 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10278923 | 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 11033499 | product, use U-2628 | 19 Jun 2033 |
| US 10933120 | product | 15 Mar 2033 |
| US 11759501 | product | 15 Mar 2033 |
| US 11759502 | product | 15 Mar 2033 |
| US 11759503 | product | 15 Mar 2033 |
| US 12594326 | product | 15 Mar 2033 |
| US 10086047 | product | 16 Dec 2031 |
| US 10960052 | product | 16 Dec 2031 |
| US 11382957 | product | 16 Dec 2031 |
| US 9278123 | product, use U-2628 | 16 Dec 2031 |
| US 8129343 | substance, product, use U-2628 | 5 Dec 2031 |
Exclusivities · 1 unexpired
| I-976 | new indication (3 years) | 17 Oct 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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 213051 · 001 · RLD | tablet, oral | 3MG | 2 May 2034 |
| 213051 · 002 · RLD | tablet, oral | 7MG | 2 May 2034 |
| 213051 · 003 · RLD | tablet, oral | 14MG | 2 May 2034 |
Expired or delisted (1)
- US 8536122 · substance, product, use U-2628 · 20 Mar 2026