semaglutide · Novo · NDA 215256
Wegovy Flextouch
Earliest generic entry, as listed
13 May 2040
Blocked by patent: US 11478533. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11478533 | use U-3861 | 13 May 2040 |
| US 12029779 | use U-3162 | 10 Oct 2038 |
| US 12551536 | use U-4418 | 10 Oct 2038 |
| US 9764003 | use U-3161 | 21 Jun 2033 |
| US 8129343 | substance, product | 5 Dec 2031 |
Exclusivities · 2 unexpired
| 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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215256 · 012 · RLD | solution, subcutaneous | 9.6MG/3ML (3.2MG/ML) | 13 May 2040 |