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Last Updated: November 5, 2024

PERAMPANEL - Generic Drug Details


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What are the generic sources for perampanel and what is the scope of patent protection?

Perampanel is the generic ingredient in one branded drug marketed by Catalyst Pharms and is included in two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Perampanel has one hundred and one patent family members in thirty-three countries.

There are five drug master file entries for perampanel. Two suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for PERAMPANEL
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PERAMPANEL
Generic Entry Dates for PERAMPANEL*:
Constraining patent/regulatory exclusivity:
Dosage:
SUSPENSION;ORAL
Generic Entry Dates for PERAMPANEL*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for PERAMPANEL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
VA Connecticut Healthcare SystemPhase 2
National Center for PTSDPhase 2
Yale UniversityPhase 2

See all PERAMPANEL clinical trials

Generic filers with tentative approvals for PERAMPANEL
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up12MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up10MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up8MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for PERAMPANEL
Paragraph IV (Patent) Challenges for PERAMPANEL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FYCOMPA Oral Suspension perampanel 0.5 mg/mL 208277 1 2022-12-20
FYCOMPA Tablets perampanel 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg 202834 2 2016-10-24

US Patents and Regulatory Information for PERAMPANEL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Catalyst Pharms FYCOMPA perampanel TABLET;ORAL 202834-004 Oct 22, 2012 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Catalyst Pharms FYCOMPA perampanel SUSPENSION;ORAL 208277-001 Apr 29, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Catalyst Pharms FYCOMPA perampanel TABLET;ORAL 202834-006 Oct 22, 2012 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Catalyst Pharms FYCOMPA perampanel TABLET;ORAL 202834-002 Oct 22, 2012 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Catalyst Pharms FYCOMPA perampanel TABLET;ORAL 202834-001 Oct 22, 2012 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Catalyst Pharms FYCOMPA perampanel TABLET;ORAL 202834-005 Oct 22, 2012 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for PERAMPANEL

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Eisai GmbH Fycompa perampanel EMEA/H/C/002434
Fycompa is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in adult and adolescent patients from 12 years of age with epilepsy.Fycompa is indicated for the adjunctive treatment of primary generalised tonic-clonic seizures in adult and adolescent patients from 12 years of age with idiopathic generalised epilepsy.
Authorised no no no 2012-07-23
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for PERAMPANEL

Country Patent Number Title Estimated Expiration
China 104402807 METHOD FOR PRODUCING CRYSTAL OF 1,2-DIHYDROPYRIDINE COMPOUND ⤷  Sign Up
Hungary 229553 1,2-DIHYDROPYRIDINE COMPOUND, PROCESS FOR PREPARATION OF THE SAME AND USE THEREOF ⤷  Sign Up
Hungary 0303398 ⤷  Sign Up
Australia 2001262723 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 0196308 ⤷  Sign Up
Brazil PI0510254 cristal de composto de 1,2-diidropiridina e método para produzir o mesmo ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PERAMPANEL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1300396 C300566 Netherlands ⤷  Sign Up PRODUCT NAME: PERAMPANEL, EEN ZOUT OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/12/776/001 .... 016 20120723
1300396 CA 2012 00052 Denmark ⤷  Sign Up
1300396 SPC/GB12/057 United Kingdom ⤷  Sign Up PRODUCT NAME: PERAMPANEL, OPTIONALLY IN THE FORM OF A SALT OR HYDRATE; REGISTERED: UK EU/1/12/776/001- 016 20120723
1300396 12C0074 France ⤷  Sign Up PRODUCT NAME: PERAMPANEL, SEL DE CELUI-CI OU HYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/12/776/001 20120723
1300396 92113 Luxembourg ⤷  Sign Up PRODUCT NAME: PERAMPANEL ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (FYCOMPA)
1764361 C 2013 025 Romania ⤷  Sign Up PRODUCT NAME: PERAMPANEL3-(2-CIANOFENIL)-5-(2-PIRIDIL)-1-FENIL-1,2-DIHIDROPIRIDIN-2-ONA; NATIONAL AUBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/776/001 - EU/1/12/776/023; DATE OF FIRST AUTHORISATION IN EEA: 20120723 THORISATION NUMBER: EU/1/12/776/001 - EU/1/12/776/023; DATE OF NATIONAL AUTHORISATION: 20120723; NUM
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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