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PERAMPANEL | N208277 | CATALYST PHARMACEUTICALS INC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Expired (1)Today

Today

8772497

Jul. 1, 2026

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
CATALYST PHARMACEUTICALS, INC. v. MSN LABORATORIES PRIVATE LIMITED et al 1:2023cv01945 1 patentANDA 218152perampanel	D.N.J.	2023-04-05	Terminated 2024-06-28	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain9 active DMFs

8 active API suppliers hold Drug Master Files for this ingredient.

TARO PHARMACEUTICAL INDUSTRIES LTDPERAMPANEL 3/4 HYDRATE, MICRONIZED

DMF 303912016

TAPI NL BVPERAMPANEL

DMF 304752016

ZYDUS LIFESCIENCES LTDPERAMPANEL

DMF 305272016

INTAS PHARMACEUTICALS LTDPERAMPANEL

DMF 306492016

MSN ORGANICS PRIVATE LTDPERAMPANEL

DMF 313122017

MSN ORGANICS PRIVATE LTDPERAMPANEL (3/4 HYDRATE)

DMF 356082021

CHEMO SMS ENTERPRISE SLPERAMPANEL

DMF 382182023

STHREE CHEMICALS PRIVATE LTDPERAMPANEL

DMF 407532024

APITORIA PHARMA PRIVATE LTDPERAMPANEL HEMISESQUIHYDRATE

DMF 408562025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Jan 21, 2025	SUPPL -9	View Letter (PDF)
Jun 29, 2023	SUPPL -5	View Letter (PDF)
Jun 4, 2019	SUPPL -4	View Letter (PDF)
Oct 1, 2018	SUPPL -2	View Letter (PDF)
Jul 28, 2017	SUPPL -1	View Letter (PDF)
May 6, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5MG/ML

RLDAB

1 patent0 exclusivities▴

SUSPENSION;ORAL | Approved: Apr 29, 2016

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8772497	Jul 1, 2026	—	Yes	—	—	—