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Last Updated: March 19, 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
National Center for PTSDPhase 2
Yale UniversityPhase 2
American Foundation for Suicide PreventionPhase 2

See all PERAMPANEL clinical trials

Generic filers with tentative approvals for PERAMPANEL
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial10MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial8MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial6MGTABLET;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 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 202834-006 Oct 22, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Catalyst Pharms FYCOMPA perampanel TABLET;ORAL 202834-004 Oct 22, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Catalyst Pharms FYCOMPA perampanel TABLET;ORAL 202834-003 Oct 22, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Catalyst Pharms FYCOMPA perampanel TABLET;ORAL 202834-003 Oct 22, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Catalyst Pharms FYCOMPA perampanel TABLET;ORAL 202834-004 Oct 22, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Catalyst Pharms FYCOMPA perampanel TABLET;ORAL 202834-005 Oct 22, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Catalyst Pharms FYCOMPA perampanel TABLET;ORAL 202834-002 Oct 22, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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
Austria E547405 ⤷  Try a Trial
Malaysia 148809 CRYSTALS OF 1,2-DIHYDROPYRIDINE COMPOUND AND THEIR PRODUCTION PROCESS ⤷  Try a Trial
Croatia P20130363 ⤷  Try a Trial
Slovenia 1764361 ⤷  Try a Trial
Japan WO2006004100 1,2−ジヒドロピリジン−2−オン化合物の製造方法 ⤷  Try a Trial
South Korea 100869271 ⤷  Try a Trial
Denmark 1764361 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PERAMPANEL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1764361 PA2013017 Lithuania ⤷  Try a 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
1300396 C01300396/01 Switzerland ⤷  Try a Trial PRODUCT NAME: PERAMPANEL; REGISTRATION NO/DATE: SWISSMEDIC 62440 14.12.2012
1300396 420 Finland ⤷  Try a Trial
1764361 C20130021 00081 Estonia ⤷  Try a Trial PRODUCT NAME: PERAMPANEEL;REG NO/DATE: K(2012)5340 LOPLIK 23.07.2012
1300396 C300566 Netherlands ⤷  Try a Trial PRODUCT NAME: PERAMPANEL, EEN ZOUT OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/12/776/001 .... 016 20120723
1300396 132012902109980 Italy ⤷  Try a Trial PRODUCT NAME: PERAMPANEL(FYCOMPA); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/12/776/001 A EU/1/12/776/016, 20120723
1300396 300566 Netherlands ⤷  Try a Trial PRODUCT NAME: PERAMPANEL, EEN ZOUT OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/12/776/001 .... 016 20120723
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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