Viewing data from:

FYCOMPA

NDA

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Eisai Inc. - Citizen Petition FDA-2013-P-0884 · 4 docket documents Eisai Inc. filed this citizen petition under 21 USC 355(c) and (j) and related provisions requesting that the FDA ensure Eisai receives the full five-year statutory exclusivity period for its two New Chemical Entity products, BELVIQ (lorcaserin hydrochloride) and FYCOMPAT (perampanel). Eisai argues	Other	2013-08-09	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

56 trials from ClinicalTrials.gov, 1 active, 40 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy NCT04015141	Phase 2	Active	Eisai Inc.	100	2019-05-31 → 2027-12-23
A Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics in Adolescents NCT01161524	Phase 2	Completed	Eisai Inc.	133	2010-09 → 2014-11
A Long-term Extension Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-Epileptic Drugs (AEDs)NCT00903786	Phase 2	Completed	Eisai Co., Ltd.	21	2009-06-17 → 2016-10-31
A Study to Investigate the Potential Pharmacokinetic Interaction of Perampanel With Oral Contraceptives in Healthy Female Subjects NCT01209858	Phase 1	Completed	Eisai Inc.	48	2010-03 → 2010-10
Bioequivalence Study Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects NCT03399734	Phase 1	Completed	Eisai Co., Ltd.	24	2017-12-18 → 2018-03-09
Dose-Tolerability Titration Study to Evaluate The Efficacy And Safety Of Perampanel (E2007) In Patients With Post-Herpetic Neuralgia (PHN)NCT00592774	Phase 2	Completed	Eisai Inc.	146	2008-01 → 2009-03
Trial Evaluating the Efficacy and Safety of Perampanel Added to Monotherapy in Participants With Partial Onset Seizures With or Without Secondary Generalization NCT02726074	Phase 4	Completed	Eisai Korea Inc.	106	2016-05-03 → 2018-04-26
Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations NCT00368108	Phase 3	Completed	Eisai Inc.	752	2006-08 → 2008-01
Perampanel as Adjunctive Therapy in Pediatrics With Partial Onset Seizures or Primary Generalized Tonic Clonic Seizures NCT02849626	Phase 3	Completed	Eisai Inc.	180	2016-11-16 → 2021-12-06
Pharmacokinetic Study With an Oral Suspension of Perampanel as Adjunctive Therapy in Pediatric Subjects With Epilepsy NCT02914314	Phase 2	Completed	Eisai Inc.	26	2017-02-20 → 2023-04-25

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$4.46

per ml

Lowest NADAC/Unit

$4.46

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
69616029038FYCOMPA 0.5 MG/ML ORAL SUSP	$4.46	ML	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$1071.65

Highest Price

$1071.65

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
69616-0290-38FYCOMPA 0.5MG/ML SUSP,ORAL	$1071.65	FSS	Catalyst Pharmaceuticals, Inc.	11/30/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

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	—	—	—