afamelanotide · Clivunel Inc · NDA 210797
Scenesse
Earliest generic entry, as listed
20 Jan 2033
Blocked by patent: US 8334265. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8334265 | use U-2638 | 20 Jan 2033 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
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 |
|---|---|---|---|
| 210797 · 001 · RLD | implant, subcutaneous | 16MG | 20 Jan 2033 |
Expired or delisted (1)
- ODE-270 · 8 Oct 2026