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Last Updated: April 22, 2024

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FYCOMPA Drug Patent Profile


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Which patents cover Fycompa, and when can generic versions of Fycompa launch?

Fycompa is a drug marketed by Catalyst Pharms and is included in two NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

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

The generic ingredient in FYCOMPA is perampanel. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the perampanel profile page.

DrugPatentWatch® Generic Entry Outlook for Fycompa

Fycompa was eligible for patent challenges on October 22, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 1, 2026. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are three tentative approvals for the generic drug (perampanel), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for FYCOMPA
Drug Prices for FYCOMPA

See drug prices for FYCOMPA

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

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

SponsorPhase
Wayne State UniversityPhase 4
Eisai Korea Inc.Phase 4
University of FloridaPhase 4

See all FYCOMPA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for FYCOMPA
Paragraph IV (Patent) Challenges for FYCOMPA
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 FYCOMPA

FYCOMPA is protected by six US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of FYCOMPA is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting FYCOMPA

1,2-dihydropyridine compounds, process for preparation of the same and use thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES WITH OR WITHOUT SECONDARILY GENERALIZED SEIZURES IN PATIENTS WITH EPILEPSY 4 YEARS OF AGE AND OLDER

1,2-dihydropyridine compounds, process for preparation of the same and use thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES WITH OR WITHOUT SECONDARILY GENERALIZED SEIZURES IN PATIENTS WITH EPILEPSY

1,2-dihydropyridine compounds, process for preparation of the same and use thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES AS ADJUNCTIVE THERAPY IN PATIENTS WITH EPILEPSY

1,2-dihydropyridine compounds, process for preparation of the same and use thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF EPILEPSY

1,2-dihydropyridine compounds, process for preparation of the same and use thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES AS ADJUNCTIVE THERAPY IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE AND OLDER

Method for producing 1, 2-dihydropyridine-2-one compound
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  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
Catalyst Pharms FYCOMPA perampanel SUSPENSION;ORAL 208277-001 Apr 29, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y 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
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 202834-001 Oct 22, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y 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 FYCOMPA

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 FYCOMPA

When does loss-of-exclusivity occur for FYCOMPA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 05258378
Estimated Expiration: ⤷  Try a Trial

Patent: 05258385
Estimated Expiration: ⤷  Try a Trial

Austria

Patent: 47405
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0510254
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 61829
Estimated Expiration: ⤷  Try a Trial

Patent: 70177
Estimated Expiration: ⤷  Try a Trial

China

Patent: 42443
Estimated Expiration: ⤷  Try a Trial

Patent: 84890
Estimated Expiration: ⤷  Try a Trial

Patent: 1544599
Estimated Expiration: ⤷  Try a Trial

Patent: 1914057
Estimated Expiration: ⤷  Try a Trial

Patent: 2382047
Estimated Expiration: ⤷  Try a Trial

Patent: 4402807
Estimated Expiration: ⤷  Try a Trial

Patent: 4402808
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0130363
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 14313
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 64361
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 64361
Estimated Expiration: ⤷  Try a Trial

Patent: 72450
Estimated Expiration: ⤷  Try a Trial

Patent: 86771
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 02127
Estimated Expiration: ⤷  Try a Trial

Patent: 04999
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 0024
Estimated Expiration: ⤷  Try a Trial

Patent: 0151
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 2006004100
Estimated Expiration: ⤷  Try a Trial

Patent: 2006004107
Estimated Expiration: ⤷  Try a Trial

Patent: 30206
Estimated Expiration: ⤷  Try a Trial

Patent: 19944
Estimated Expiration: ⤷  Try a Trial

Patent: 07099781
Estimated Expiration: ⤷  Try a Trial

Patent: 12021029
Estimated Expiration: ⤷  Try a Trial

Jordan

Patent: 32
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 8809
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 06014458
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 520
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 0720
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 9101
Estimated Expiration: ⤷  Try a Trial

Patent: 065754
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 64361
Estimated Expiration: ⤷  Try a Trial

Patent: 72450
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 64361
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 23930
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 752
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 64361
Estimated Expiration: ⤷  Try a Trial

Patent: 72450
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0609274
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 0939743
Estimated Expiration: ⤷  Try a Trial

Patent: 1187218
Estimated Expiration: ⤷  Try a Trial

Patent: 070008617
Estimated Expiration: ⤷  Try a Trial

Patent: 070028459
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 04697
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 46660
Estimated Expiration: ⤷  Try a Trial

Patent: 0606144
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering FYCOMPA around the world.

Country Patent Number Title Estimated Expiration
China 101544599 Crystal of 1,2-dihydropyridine compound ⤷  Try a Trial
Taiwan 200606144 Crystal of 1,2-dihydropyridine compound ⤷  Try a Trial
Croatia P20130363 ⤷  Try a Trial
South Korea 20070094994 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FYCOMPA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1300396 C01300396/01 Switzerland ⤷  Try a Trial PRODUCT NAME: PERAMPANEL; REGISTRATION NO/DATE: SWISSMEDIC 62440 14.12.2012
1300396 SPC/GB12/057 United Kingdom ⤷  Try a Trial PRODUCT NAME: PERAMPANEL, OPTIONALLY IN THE FORM OF A SALT OR HYDRATE; REGISTERED: UK EU/1/12/776/001- 016 20120723
1300396 C300565 Netherlands ⤷  Try a Trial PRODUCT NAME: PERAMPANEL, EEN ZOUT OF EEN HYDRAAT ERVAN; REGISTRATION NO/DATE: EU/1/12/776/001 .....016 20120723
1300396 2012/049 Ireland ⤷  Try a Trial PRODUCT NAME: PERAMPANEL, OPTIONALLY A SALT OR HYDRATE THEREOF.; REGISTRATION NO/DATE: EU/1/12/776/001-EU/1/12/776/016 20120723
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.