Applicant, as named in the Orange Book

Catalyst Pharms

Next listed expiry: Firdapse on 25 Feb 2037. 2 products with live protection, 2 without.

Products with listed protection

Drug	Ingredient	Earliest generic entry	Basis
Firdapse NDA 208078 amifampridine phosphate	amifampridine phosphate	25 Feb 2037 patent	patent
Agamree NDA 215239 vamorolone	vamorolone	16 Jul 2040 patent	patent

Recent events

Fycompa · Generic approved · ANDA 209538, TaroApproved 25 Nov 2025Detected 25 Oct 2026
Fycompa · Generic approved · ANDA 220492, Aurobindo Pharma LtdApproved 2 Oct 2026Detected 25 Oct 2026
Fycompa · Generic approved · ANDA 219052, TaroApproved 15 Jun 2026Detected 25 Oct 2026
Fycompa · Generic approved · ANDA 218178, MsnApproved 25 Nov 2025Detected 25 Oct 2026

Products without listed protection (2)

Drug	Ingredient	Earliest generic entry	Basis
Fycompa NDA 202834 · 6 strengths perampanel	perampanel	open now no listed protection	no listed protection
Fycompa NDA 208277 perampanel	perampanel	open now no listed protection	no listed protection