setmelanotide acetate · Rhythm · NDA 213793
Imcivree
Earliest generic entry, as listed
4 Jul 2034
Blocked by patent: US 11129869.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11129869 | product | 4 Jul 2034 |
| US 8039435 | substance, product | 21 Aug 2032 |
| US 9458195 | substance, product | 13 Oct 2027 |
Exclusivities · 6 unexpired
| ODE-508 | orphan drug (7 years) | 20 Dec 2031 |
| ODE-509 | orphan drug (7 years) | 20 Dec 2031 |
| ODE-402 | orphan drug (7 years) | 16 Jun 2029 |
| I-987 | new indication (3 years) | 19 Mar 2029 |
| NPP | new patient population | 20 Dec 2027 |
| ODE-336 | orphan drug (7 years) | 25 Nov 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 |
|---|---|---|---|
| 213793 · 001 · RLD | solution, subcutaneous | EQ 10MG BASE/ML (EQ 10MG BASE/ML) | 4 Jul 2034 |