Perampanel - Generic Drug Details

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

International Patents:	101
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	69
Patent Applications:	705
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for perampanel
What excipients (inactive ingredients) are in perampanel?	perampanel excipients list
DailyMed Link:	perampanel at DailyMed

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

Dosage:

SUSPENSION;ORAL

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

Sponsor	Phase
VA Connecticut Healthcare System	Phase 2
National Center for PTSD	Phase 2
Yale University	Phase 2

See all perampanel clinical trials

Generic filers with tentative approvals for PERAMPANEL

Applicant	Application No.	Strength	Dosage Form
		12MG	TABLET;ORAL
		10MG	TABLET;ORAL
		8MG	TABLET;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

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

Anatomical Therapeutic Chemical (ATC) Classes for perampanel

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

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	202834-002	Oct 22, 2012		RX	Yes	No				Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-004	Oct 22, 2012		RX	Yes	No				Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-002	Oct 22, 2012		RX	Yes	No			Y	Y
Catalyst Pharms	FYCOMPA	perampanel	SUSPENSION;ORAL	208277-001	Apr 29, 2016		RX	Yes	Yes				Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-005	Oct 22, 2012		RX	Yes	No				Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-003	Oct 22, 2012		RX	Yes	No			Y	Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-004	Oct 22, 2012		RX	Yes	No			Y	Y

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

International Patents for perampanel

Country	Patent Number	Title	Estimated Expiration
China	1984890	Method for producing 1, 2-dihydropyridine-2-one compound
Japan	5419944
Germany	60137426
Portugal	1764361
Mexico	PA02012314	COMPUESTOS DE 1,2-DIHIDROPIRIDINA, METODO DE FABRICACION Y UTILIZACION DE LOS MISMOS. (1,2-DIHYDROPYRIDINE COMPOUNDS, PROCESS FOR PREPARATION OF THE SAME AND USE THEREOF.)
Japan	WO2001096308	１，２−ジヒドロピリジン化合物、その製造法およびその用途
China	101914057	Crystal of 1,2-dihydropyridine compound and method for producing same

Supplementary Protection Certificates for perampanel

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1764361	C20130021 00081	Estonia		PRODUCT NAME: PERAMPANEEL;REG NO/DATE: K(2012)5340 LOPLIK 23.07.2012
1300396	2013C/003	Belgium		PRODUCT NAME: FYCOMPA-PERAMPANEL; AUTHORISATION NUMBER AND DATE: EU/1/12/776/001 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	92113	Luxembourg		PRODUCT NAME: PERAMPANEL ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (FYCOMPA)
1300396	300566	Netherlands		PRODUCT NAME: PERAMPANEL, EEN ZOUT OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/12/776/001 .... 016 20120723
1764361	173 5-2013	Slovakia		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	C01300396/01	Switzerland		PRODUCT NAME: PERAMPANEL; REGISTRATION NO/DATE: SWISSMEDIC 62440 14.12.2012