perampanel · Catalyst Pharms · NDA 202834, 208277
Fycompa
Earliest generic entry, as listed · earliest of 7 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
- Generic approved · ANDA 209538, Taro · 202834-001Approved 25 Nov 2025Detected 25 Oct 2026Historical import
- Generic approved · ANDA 220492, Aurobindo Pharma Ltd · 202834-001Approved 2 Oct 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219052, Taro · 208277-001Approved 15 Jun 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 218178, Msn · 202834-001Approved 25 Nov 2025Detected 25 Oct 2026Historical import
Products covered · 7
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 202834 · 001 · RLD | tablet, oral | 2MG | open |
| 202834 · 002 · RLD | tablet, oral | 4MG | open |
| 202834 · 003 · RLD | tablet, oral | 6MG | open |
| 202834 · 004 · RLD | tablet, oral | 8MG | open |
| 202834 · 005 · RLD | tablet, oral | 10MG | open |
| 202834 · 006 · RLD | tablet, oral | 12MG | open |
| 208277 · 001 · RLD | suspension, oral | 0.5MG/ML | open |
Expired or delisted (1)
- US 8772497 · substance · 1 Jul 2026