Viewing data from:

FYCOMPA

NDA

PERAMPANEL | N202834 | CATALYST PHARMACEUTICALS INC

6 strengths1 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

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 | 12 NDCs

Highest NADAC/Unit

$39.17

per ea

Lowest NADAC/Unit

$19.76

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
69616028230FYCOMPA 12 MG TABLET	$39.17	EA	Brand	$20.18	2026-06-17
62856028230FYCOMPA 12 MG TABLET	$39.17	EA	Brand	$20.18	2026-06-17
69616027630FYCOMPA 6 MG TABLET	$39.14	EA	Brand	$16.22	2026-06-17
62856027630FYCOMPA 6 MG TABLET	$39.14	EA	Brand	$16.22	2026-06-17
62856027830FYCOMPA 8 MG TABLET	$39.13	EA	Brand	$18.93	2026-06-17
69616027830FYCOMPA 8 MG TABLET	$39.13	EA	Brand	$18.93	2026-06-17

Showing 6 of 12 NDCs.

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

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (6 FSS)

Lowest Price

$414.60

Highest Price

$823.67

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
69616-0276-30FYCOMPA 6MG TAB	$822.80	FSS	Catalyst Pharmaceuticals, Inc.	11/30/2026
69616-0272-30FYCOMPA 2MG TAB	$414.60	FSS	Catalyst Pharmaceuticals, Inc.	11/30/2026
69616-0274-30FYCOMPA 4MG TAB	$820.02	FSS	Catalyst Pharmaceuticals, Inc.	11/30/2026
69616-0278-30FYCOMPA 8MG TAB	$822.01	FSS	Catalyst Pharmaceuticals, Inc.	11/30/2026
69616-0280-30FYCOMPA 10MG TAB	$823.67	FSS	Catalyst Pharmaceuticals, Inc.	11/30/2026
69616-0282-30FYCOMPA 12MG TAB	$823.16	FSS	Catalyst Pharmaceuticals, Inc.	11/30/2026

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

Medicare Part D Spending

CMS annual spending data for Fycompa (2024)

Total Spending

$75.7M

Total Claims

59,762

Beneficiaries

6,558

Avg Cost/Unit

$37.61

Spending Trend

$43.1M(2019)→$51.6M(2020)→$57.4M(2021)→$65.6M(2022)→$72.0M(2023)→$75.7M(2024)

YoY Change:+1.2%

5yr CAGR:+5.0%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

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

12 letters from Drugs@FDA

Date	Submission	Document
Feb 20, 2024	SUPPL -19	View Letter (PDF)
Oct 27, 2023	SUPPL -18	View Letter (PDF)
Jun 4, 2019	SUPPL -16	View Letter (PDF)
Oct 1, 2018	SUPPL -14	View Letter (PDF)
Jul 28, 2017	SUPPL -12	View Letter (PDF)
Nov 8, 2016	SUPPL -11	View Letter (PDF)
Jun 24, 2015	SUPPL -5	View Letter (PDF)
Nov 17, 2014	SUPPL -6	View Letter (PDF)
Feb 26, 2014	SUPPL -3	View Letter (PDF)
Feb 19, 2014	SUPPL -4	View Letter (PDF)
Jul 3, 2013	SUPPL -1	View Letter (PDF)
Oct 26, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

Sort:

#001 — 2MG

RLDAB

1 patent0 exclusivities▴