gepirone hydrochloride · Fabre Kramer · NDA 021164
Exxua
Earliest generic entry, as listed · earliest of 4 marketed strengths
2 Sep 2030
Blocked by patent: US 7538116. 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 7538116 | use U-3699 · sets the listed date | 2 Sep 2030 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 22 Sep 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 · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021164 · 001 · RLD | tablet, extended release, oral | EQ 18.2MG BASE | 2 Sep 2030 |
| 021164 · 002 · RLD | tablet, extended release, oral | EQ 36.3MG BASE | 2 Sep 2030 |
| 021164 · 003 · RLD | tablet, extended release, oral | EQ 54.5MG BASE | 2 Sep 2030 |
| 021164 · 004 · RLD | tablet, extended release, oral | EQ 72.6MG BASE | 2 Sep 2030 |