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PERAMPANEL

ANDA

PERAMPANEL | A218152 | MSN LABORATORIES PRIVATE LTD

1 strength0 unique patents1 unique exclusivity

Reference Listed Drug: FYCOMPA(TE code: AB)

Patent Timeline

0 unique patents, 1 exclusivity by expiration date

TodayExclusivity

Today

Jun. 14, 2026

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).

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.

Products (1)

#001 — 0.5MG/ML

0 patents1 exclusivity▴

SUSPENSION;ORAL | Approved: Jul 11, 2025

Code	Date	Status
PC	Jun 14, 2026	Expired

Change History (1)

Recent changes detected for this application.

ADDED7/1/2026

New: New record