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ICOSAPENT ETHYL - Generic Drug Details

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What are the generic sources for icosapent ethyl and what is the scope of freedom to operate?

Icosapent ethyl is the generic ingredient in two branded drugs marketed by Apotex, Dr Reddys, Hikma Pharms, Teva Pharms Usa, and Amarin Pharms, and is included in five NDAs. There are sixty-three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Icosapent ethyl has two hundred and ninety-three patent family members in forty-three countries.

There are twelve drug master file entries for icosapent ethyl. Four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ICOSAPENT ETHYL

International Patents:	293
US Patents:	63
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	47
Clinical Trials:	14
Patent Applications:	3,560
Drug Prices:	Drug price trends for ICOSAPENT ETHYL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ICOSAPENT ETHYL
What excipients (inactive ingredients) are in ICOSAPENT ETHYL?	ICOSAPENT ETHYL excipients list
DailyMed Link:	ICOSAPENT ETHYL at DailyMed

See drug prices for ICOSAPENT ETHYL

Recent Clinical Trials for ICOSAPENT ETHYL

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

Sponsor	Phase
Canadian Medical and Surgical Knowledge Translation Research Group	Phase 4
St. Michael's Hospital, Toronto	Phase 4
University of Western Ontario, Canada	Phase 4

See all ICOSAPENT ETHYL clinical trials

Generic filers with tentative approvals for ICOSAPENT ETHYL

Applicant	Application No.	Strength	Dosage Form
		1GM	CAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for ICOSAPENT ETHYL

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 ICOSAPENT ETHYL

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	202057-001	Jul 26, 2012	AB	RX	Yes	Yes
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
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

Expired US Patents for ICOSAPENT ETHYL

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 ICOSAPENT ETHYL

Country	Patent Number	Estimated Expiration
European Patent Office	3363433
Hong Kong	1226307
European Patent Office	2424356
Chile	2014003534
Poland	2395991
European Patent Office	3318255
Dominican Republic	P2014000301

Supplementary Protection Certificates for ICOSAPENT ETHYL

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: