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Last Updated: December 8, 2022

Perampanel - Generic Drug Details


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What are the generic sources for perampanel and what is the scope of freedom to operate?

Perampanel is the generic ingredient in one branded drug marketed by Eisai Inc 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. One supplier is listed for this compound. There are three tentative approvals for this compound.

Summary for perampanel
International Patents:101
US Patents:2
Tradenames:1
Applicants:1
NDAs:2
Drug Master File Entries: 5
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 56
Clinical Trials: 67
Patent Applications: 988
What excipients (inactive ingredients) are in perampanel?perampanel excipients list
DailyMed Link:perampanel at DailyMed
Recent Clinical Trials for perampanel

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

SponsorPhase
University of FloridaPhase 4
Kimford Jay MeadorPhase 4
Assistance Publique Hopitaux De MarseilleN/A

See all perampanel clinical trials

Generic filers with tentative approvals for PERAMPANEL
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing4MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing2MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing12MGTABLET;ORAL

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

Paragraph IV (Patent) Challenges for PERAMPANEL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
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
Eisai Inc FYCOMPA perampanel SUSPENSION;ORAL 208277-001 Apr 29, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Eisai Inc FYCOMPA perampanel TABLET;ORAL 202834-003 Oct 22, 2012 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Eisai Inc FYCOMPA perampanel TABLET;ORAL 202834-004 Oct 22, 2012 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Eisai Inc FYCOMPA perampanel SUSPENSION;ORAL 208277-001 Apr 29, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Eisai Inc FYCOMPA perampanel TABLET;ORAL 202834-001 Oct 22, 2012 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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
Israel 152848 See Plans and Pricing
Taiwan I346660 See Plans and Pricing
Japan 2012207021 1,2-DIHYDROPYRIDINE COMPOUND, METHOD FOR PRODUCING THE SAME AND USE THEREOF See Plans and Pricing
Taiwan I292757 See Plans and Pricing
Canada 2412172 COMPOSES 1,2-DIHYDROPYRIDINE, LEUR PROCEDE DE PREPARATION ET LEUR UTILISATION (1,2-DIHYDROPYRIDINE COMPOUNDS, MANUFACTURING METHOD THEREOF AND USE THEREOF) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for perampanel

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1300396 12C0074 France See Plans and Pricing PRODUCT NAME: PERAMPANEL, SEL DE CELUI-CI OU HYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/12/776/001 20120723
1300396 C300566 Netherlands See Plans and Pricing PRODUCT NAME: PERAMPANEL, EEN ZOUT OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/12/776/001 .... 016 20120723
1300396 300565 Netherlands See Plans and Pricing PRODUCT NAME: PERAMPANEL, EEN ZOUT OF EEN HYDRAAT ERVAN; REGISTRATION NO/DATE: EU/1/12/776/001 .....016 20120723
1300396 CA 2012 00052 Denmark See Plans and Pricing
1300396 2013C/003 Belgium See Plans and Pricing PRODUCT NAME: FYCOMPA-PERAMPANEL; AUTHORISATION NUMBER AND DATE: EU/1/12/776/001 20120723
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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