flibanserin · Sprout Pharms · NDA 022526
Addyi
Earliest generic entry, as listed
13 Dec 2028
Blocked by exclusivity: I-983.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 7151103 | use U-1734 | 9 May 2028 |
Exclusivities · 1 unexpired
| I-983 | new indication (3 years) | 13 Dec 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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022526 · 001 · RLD | tablet, oral | 100MG | 13 Dec 2028 |