brivaracetam · Ucb Inc · NDA 205836, 205837, 205838
Briviact
2 of 7 marketed strengths have no unexpired patent or exclusivity listed.
Blocked by patent: US 10729653.
FDA has approved 16 generic applications (ANDAs) for Briviact, though its earliest generic-entry date is 9 Apr 2030 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10729653 | drug product · sets the listed date | 9 Apr 2030 |
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
- Generic approved · ANDA 220164, Lupin · 205838-001Approved 23 Feb 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 220136, Zhejiang Jutai Pharm · 205836-001Approved 8 Sep 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 218494, Zhejiang Poly Pharm · 205838-001Approved 23 Feb 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 221301, Zydus Lifesciences · 205838-001Approved 20 Oct 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219952, Sciegen Pharms · 205836-001Approved 1 Jul 2026Detected 25 Oct 2026Historical import
- First generic approved · ANDA 214924, Msn · 205837-001Approved 23 Feb 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 214924, Msn · 205837-001Approved 23 Feb 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 214921, Msn · 205836-001Approved 13 Nov 2025Detected 25 Oct 2026Historical import
- First generic approved · ANDA 214922, Msn · 205838-001Approved 19 Feb 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 214922, Msn · 205838-001Approved 19 Feb 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 220470, Breckenridge · 205836-001Approved 23 Feb 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219766, Shandong · 205837-001Approved 13 Jul 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219772, Alkem Labs Ltd · 205838-001Approved 23 Feb 2026Detected 25 Oct 2026Historical import
- First generic approved · ANDA 214880, Micro Labs · 205837-001Approved 23 Feb 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 214880, Micro Labs · 205837-001Approved 23 Feb 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 214875, Apotex · 205836-001Approved 23 Feb 2026Detected 25 Oct 2026Historical import
- First generic approved · ANDA 218249, Hainan Poly · 205837-001Approved 23 Feb 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 218249, Hainan Poly · 205837-001Approved 23 Feb 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 220385, Regcon Holdings · 205838-001Approved 23 Feb 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 220288, Aurobindo Pharma · 205838-001Approved 10 Aug 2026Detected 25 Oct 2026Historical import
Products covered · 7
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 205836 · 001 · RLD | tablet, oral | 10MG | 9 Apr 2030 |
| 205836 · 002 · RLD | tablet, oral | 25MG | 9 Apr 2030 |
| 205836 · 003 · RLD | tablet, oral | 50MG | 9 Apr 2030 |
| 205836 · 004 · RLD | tablet, oral | 75MG | 9 Apr 2030 |
| 205836 · 005 · RLD | tablet, oral | 100MG | 9 Apr 2030 |
| 205837 · 001 · RLD | solution, intravenous | 50MG/5ML (10MG/ML) | open |
| 205838 · 001 · RLD | solution, oral | 10MG/ML | open |
Expired or delisted (3)
- US 6911461 · substance, product, use U-2295 · 21 Feb 2026
- US 6911461 · substance, product, use U-1815 · 21 Feb 2026
- US 6911461 · substance, product, use U-2130 · 21 Feb 2026