levetiracetam · Ucb Inc · NDA 021035, 021505, 021872
Keppra
2 of 6 marketed strengths have no unexpired patent or exclusivity listed.
Blocked by patent: US 8802142 (pediatric extension).
FDA has approved 4 generic applications (ANDAs) for Keppra, though its earliest generic-entry date is 7 Dec 2031 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
2 Orange Book listing rows for 1 patent, including 1 pediatric extension. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 8802142 | drug product | 7 Dec 2031 |
| US 8802142 listing row | drug product | 7 Jun 2031 |
| US 8802142 listing row | pediatric extension · sets the listed date | 7 Dec 2031 |
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 approved · 021505-00121 Nov 2025
- 25 Oct 2026Generic approved · 021872-0012 Dec 2025
- 25 Oct 2026Generic approved · 021872-0018 May 2026
- 25 Oct 2026Generic approved · 021872-0016 Aug 2026
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021035 · 001 · RLD | tablet, oral | 250MG | 7 Dec 2031 |
| 021035 · 002 · RLD | tablet, oral | 500MG | 7 Dec 2031 |
| 021035 · 003 · RLD | tablet, oral | 750MG | 7 Dec 2031 |
| 021035 · 004 · RLD | tablet, oral | 1GM | 7 Dec 2031 |
| 021505 · 001 · RLD | solution, oral | 100MG/ML | open |
| 021872 · 001 · RLD | injectable, intravenous | 500MG/5ML (100MG/ML) | open |