oxcarbazepine · Novartis · NDA 021014, 021285
Trileptal
Earliest generic entry, as listed · earliest of 4 marketed strengths
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
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 · 021014-00129 Apr 2026
- 25 Oct 2026Generic approved · 021285-0019 Mar 2026
- 25 Oct 2026Generic approved · 021014-0012 Mar 2026
- 25 Oct 2026Generic approved · 021285-00129 May 2026
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021014 · 001 · RLD | tablet, oral | 150MG | open |
| 021014 · 002 · RLD | tablet, oral | 300MG | open |
| 021014 · 003 · RLD | tablet, oral | 600MG | open |
| 021285 · 001 · RLD | suspension, oral | 300MG/5ML | open |