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FYCOMPA Drug Patent Profile

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

Summary for FYCOMPA

International Patents:	101
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	22
Patent Applications:	306
Drug Prices:	Drug price information for FYCOMPA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FYCOMPA
What excipients (inactive ingredients) are in FYCOMPA?	FYCOMPA excipients list
DailyMed Link:	FYCOMPA at DailyMed

See drug prices for FYCOMPA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FYCOMPA

NDA:

208277

Dosage:

SUSPENSION;ORAL

NDA:

202834

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

Sponsor	Phase
Wayne State University	Phase 4
Eisai Korea Inc.	Phase 4
University of Florida	Phase 4

See all FYCOMPA clinical trials

Pharmacology for FYCOMPA

Drug Class	Noncompetitive AMPA Glutamate Receptor Antagonist
Mechanism of Action	AMPA Receptor Antagonists Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A4 Inhibitors UGT1A9 Inhibitors UGT2B7 Inhibitors

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.

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

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			Y	Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-002	Oct 22, 2012		RX	Yes	No				Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-003	Oct 22, 2012		RX	Yes	No				Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-001	Oct 22, 2012		RX	Yes	No			Y	Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-005	Oct 22, 2012		RX	Yes	No				Y

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

International Patents for FYCOMPA

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

Country	Patent Number	Title	Estimated Expiration
Austria	E547405
Mexico	PA06014458	CRISTAL DEL COMPUESTO DE 1,2-DIHIDROPIRIDINA Y METODO PARA PRODUCIR EL MISMO. (CRYSTAL OF 1,2-DIHYDROPYRIDINE COMPOUND AND METHOD FOR PRODUCING SAME.)
Slovenia	1772450
Japan	5030206
Australia	2005258385	Crystal of 1,2-dihydropyridine compound and method for producing same

Supplementary Protection Certificates for FYCOMPA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1300396	1290045-2	Sweden		PRODUCT NAME: PERAMPANEL OCH SALTER OCH HYDRATER DAERAV; REG. NO/DATE: EU/1/12/776/001 20120723
1300396	C01300396/01	Switzerland		PRODUCT NAME: PERAMPANEL; REGISTRATION NO/DATE: SWISSMEDIC 62440 14.12.2012
1300396	300566	Netherlands		PRODUCT NAME: PERAMPANEL, EEN ZOUT OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/12/776/001 .... 016 20120723
1764361	C 2013 025	Romania		PRODUCT NAME: PERAMPANEL3-(2-CIANOFENIL)-5-(2-PIRIDIL)-1-FENIL-1,2-DIHIDROPIRIDIN-2-ONA; NATIONAL AUBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/776/001 - EU/1/12/776/023; DATE OF FIRST AUTHORISATION IN EEA: 20120723 THORISATION NUMBER: EU/1/12/776/001 - EU/1/12/776/023; DATE OF NATIONAL AUTHORISATION: 20120723; NUM
1300396	2012/049	Ireland		PRODUCT NAME: PERAMPANEL, OPTIONALLY A SALT OR HYDRATE THEREOF.; REGISTRATION NO/DATE: EU/1/12/776/001-EU/1/12/776/016 20120723