bremelanotide acetate · Cosette · NDA 210557
Vyleesi (Autoinjector)
Earliest generic entry, as listed
29 Apr 2041
Blocked by patent: US 11590209. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11590209 | use U-3539 · sets the listed date | 29 Apr 2041 |
| US 10286034 | use U-2568 | 5 Nov 2033 |
| US 9352013 | use U-2568 | 5 Nov 2033 |
| US 9700592 | use U-2568 | 5 Nov 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 |
|---|---|---|---|
| 210557 · 001 · RLD | solution, subcutaneous | EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) | 29 Apr 2041 |