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Last Updated: January 19, 2021

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FYCOMPA Drug Profile

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

Fycompa is a drug marketed by Eisai Inc and is included in two NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

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. One supplier is listed for this compound. Additional details are available on the perampanel profile page.

US ANDA Litigation and 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 is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

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

Indicators of Generic Entry

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Summary for FYCOMPA
International Patents:101
US Patents:2
Applicants:1
NDAs:2
Suppliers / Packagers: 1
Bulk Api Vendors: 51
Clinical Trials: 14
Drug Prices: Drug price information for FYCOMPA
DailyMed Link:FYCOMPA at DailyMed
Drug patent expirations by year for FYCOMPA
Drug Prices for FYCOMPA

See drug prices for FYCOMPA

Generic Entry Opportunity 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
National Cancer Institute (NCI)Phase 4
Mayo ClinicPhase 4
Kimford Jay MeadorPhase 4

See all FYCOMPA clinical trials

Pharmacology for FYCOMPA
Paragraph IV (Patent) Challenges for FYCOMPA
Tradename Dosage Ingredient NDA Submissiondate
FYCOMPA TABLET;ORAL perampanel 202834 2016-10-24

US Patents and Regulatory Information for FYCOMPA

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   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   Start Trial
Eisai Inc FYCOMPA perampanel TABLET;ORAL 202834-003 Oct 22, 2012 RX Yes No   Start Trial   Start Trial 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 FYCOMPA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1764361 173 5-2013 Slovakia   Start Trial PRODUCT NAME: PERAMPANEL; NAT. REGISTRATION NO/DATE: EU/1/12/776/001 - EU/1/12/776/016 20120723; FIRST REGISTRATION: EU EU/1/12/776/001 - EU/1 /12/776/016 20120723
1300396 92113 Luxembourg   Start Trial PRODUCT NAME: PERAMPANEL ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (FYCOMPA)
1300396 C300566 Netherlands   Start 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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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.