gabapentin enacarbil · Azurity · NDA 022399
Horizant
Earliest generic entry, as listed · earliest of 2 marketed strengths
10 Jun 2029
Blocked by patent: US 8795725, US 8795725.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8795725 | product, use U-1231 | 10 Jun 2029 |
| US 8795725 | product, use U-1247 | 10 Jun 2029 |
| US 8026279 | substance, product | 10 Nov 2026 |
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
- 25 Oct 2026Generic tentatively approved · 022399-00120 Mar 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022399 · 001 · RLD | tablet, extended release, oral | 600MG | 10 Jun 2029 |
| 022399 · 002 · RLD | tablet, extended release, oral | 300MG | 10 Jun 2029 |
Expired or delisted (1)
- US 8114909 · use U-1231 · 11 Apr 2026