DrugPatentWatch Database Preview

VASCEPA Drug Profile

Email this page to a colleague

« Back to Dashboard

When do Vascepa patents expire, and what generic alternatives are available?

Vascepa is a drug marketed by Amarin Pharms and is included in one NDA. There are sixty-two patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and sixty patent family members in forty-one countries.

The generic ingredient in VASCEPA is icosapent ethyl. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the icosapent ethyl profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vascepa

A generic version of VASCEPA was approved as icosapent ethyl by HIKMA on May 21^st, 2020.

Summary for VASCEPA

International Patents:	260
US Patents:	62
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	13
Patent Applications:	1,651
Drug Prices:	Drug price information for VASCEPA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VASCEPA
What excipients (inactive ingredients) are in VASCEPA?	VASCEPA excipients list
DailyMed Link:	VASCEPA at DailyMed

See drug prices for VASCEPA

Recent Clinical Trials for VASCEPA

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

Sponsor	Phase
University of Western Ontario, Canada	Phase 4
HLS Therapeutics, Inc	Phase 4
Canadian Medical and Surgical Knowledge Translation Research Group	Phase 4

See all VASCEPA clinical trials

Paragraph IV (Patent) Challenges for VASCEPA

Tradename	Dosage	Ingredient	NDA	Submissiondate
VASCEPA	CAPSULE;ORAL	icosapent ethyl	202057	2017-08-29
VASCEPA	CAPSULE;ORAL	icosapent ethyl	202057	2016-07-26

US Patents and Regulatory Information for VASCEPA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017		RX	Yes	No
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017		RX	Yes	No
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-001	Jul 26, 2012	AB	RX	Yes	Yes

Expired US Patents for VASCEPA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-001	Jul 26, 2012
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017

International Patents for VASCEPA

Country	Patent Number	Estimated Expiration
Singapore	175389
Portugal	3278665
Japan	2018184463

Supplementary Protection Certificates for VASCEPA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0253738	96C0009	Belgium		PRODUCT NAME: CONCENTRE A 85 % D'OMEGA POLYINSATURES; QUANTITE CORRESPONDANT A :; ESTERS ETHYLIQUES D'ACIDE EICOSAPENTAENOIQUE (EPA) ET D'ACIDE DOCOSAHEXAENOIQUE (DHA); ALPHA TOCOPHEROL; NAT. REGISTRATION NO/DATE: NL 20819 19951002; FIRST REGISTRATION: