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Last Updated: February 26, 2021

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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 two 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
Suppliers / Packagers: 1
Bulk Api Vendors: 53
Clinical Trials: 61
Patent Applications: 367
DailyMed Link:perampanel at DailyMed
Recent Clinical Trials for perampanel

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

SponsorPhase
National Cancer Institute (NCI)Phase 4
Mayo ClinicPhase 4
Kimford Jay MeadorPhase 4

See all perampanel clinical trials

Generic filers with tentative approvals for PERAMPANEL
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial12MGTABLET;ORAL
  Start Trial  Start Trial10MGTABLET;ORAL
  Start Trial  Start Trial8MGTABLET;ORAL

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

Pharmacology for perampanel
Paragraph IV (Patent) Challenges for PERAMPANEL
Tradename Dosage Ingredient NDA Submissiondate
FYCOMPA TABLET;ORAL perampanel 202834 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 TABLET;ORAL 202834-003 Oct 22, 2012 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Eisai Inc FYCOMPA perampanel TABLET;ORAL 202834-001 Oct 22, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Eisai Inc FYCOMPA perampanel TABLET;ORAL 202834-004 Oct 22, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Eisai Inc FYCOMPA perampanel SUSPENSION;ORAL 208277-001 Apr 29, 2016 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Eisai Inc FYCOMPA perampanel TABLET;ORAL 202834-006 Oct 22, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Eisai Inc FYCOMPA perampanel TABLET;ORAL 202834-002 Oct 22, 2012 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for perampanel

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1300396 92113 Luxembourg   Start Trial PRODUCT NAME: PERAMPANEL ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (FYCOMPA)
1300396 132012902109980 Italy   Start Trial PRODUCT NAME: PERAMPANEL(FYCOMPA); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/12/776/001 A EU/1/12/776/016, 20120723
1764361 PA2013017,C1764361 Lithuania   Start Trial PRODUCT NAME: PERAMPANELUM; REGISTRATION NO/DATE: EU/1/12/776/001 - EU/1/12/776/016, 2012 07 23 EU/1/12/776/017 - EU1/12/776/023 20121029
1764361 C20130021 00081 Estonia   Start Trial PRODUCT NAME: PERAMPANEEL;REG NO/DATE: K(2012)5340 LOPLIK 23.07.2012
1300396 300566 Netherlands   Start Trial PRODUCT NAME: PERAMPANEL, EEN ZOUT OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/12/776/001 .... 016 20120723
1300396 2013C/003 Belgium   Start Trial 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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