phentermine hydrochloride; topiramate · Vivus Llc · NDA 022580
Qsymia
Earliest generic entry, as listed · earliest of 4 marketed strengths
14 Jun 2029
Blocked by patent: US 8580299. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8580299 | use U-3399 · sets the listed date | 14 Jun 2029 |
| US 8580298 | drug product | 15 May 2029 |
| US 8895057 | use U-3398 | 9 Jun 2028 |
| US 8895058 | drug product | 9 Jun 2028 |
| US 9011905 | drug product | 9 Jun 2028 |
| US 9011906 | use U-3398 | 9 Jun 2028 |
Exclusivities · 1 unexpired
| M-308 | miscellaneous (3 years) | 13 Sep 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 · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022580 · 001 · RLD | capsule, extended release, oral | EQ 3.75MG BASE;23MG | 14 Jun 2029 |
| 022580 · 002 · RLD | capsule, extended release, oral | EQ 7.5MG BASE;46MG | 14 Jun 2029 |
| 022580 · 003 · RLD | capsule, extended release, oral | EQ 11.25MG BASE;69MG | 14 Jun 2029 |
| 022580 · 004 · RLD | capsule, extended release, oral | EQ 15MG BASE;92MG | 14 Jun 2029 |