ICOSAPENT ETHYL - Generic Drug Details

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, Teva Pharms Usa, and Amarin Pharms, and is included in five NDAs. There are sixty-nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Icosapent ethyl has three hundred and twenty-four patent family members in forty-four countries.

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

Summary for ICOSAPENT ETHYL

International Patents:	324
US Patents:	69
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	17
Patent Applications:	4,092
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
National Cancer Institute (NCI)	Phase 1/Phase 2
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	Strength	NDA	ANDAs Submitted	Submissiondate
VASCEPA	Capsules	icosapent ethyl	500 mg	202057	1	2017-08-29
VASCEPA	Capsules	icosapent ethyl	1 g	202057	4	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	202057-001	Jul 26, 2012	AB	RX	Yes	Yes
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017	AB	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	AB	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

EU/EMA Drug Approvals for ICOSAPENT ETHYL

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Amarin Pharmaceuticals Ireland Limited	Vazkepa	icosapent ethyl	EMEA/H/C/005398 Indicated to reduce cardiovascular risk as an adjunct to statin therapy.	Authorised	no	no	no	2021-03-26

International Patents for ICOSAPENT ETHYL

Country	Patent Number	Title	Estimated Expiration
China	102526733	Composition for preventing onset and/or recurrence of cardiovascular events
Spain	2768091
Croatia	P20201830
Russian Federation	2011137415	СПОСОБЫ ЛЕЧЕНИЯ ГИПЕРТРИГЛИЦЕРИДЕМИИ

Supplementary Protection Certificates for ICOSAPENT ETHYL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2443246	C202130052	Spain		PRODUCT NAME: ICOSAPENTO DE ETILO; NATIONAL AUTHORISATION NUMBER: EU/1/20/1524; DATE OF AUTHORISATION: 20210326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1524; DATE OF FIRST AUTHORISATION IN EEA: 20210326
2443246	122021000056	Germany		PRODUCT NAME: VAZKEPA (ICOSAPENT ETHYL); REGISTRATION NO/DATE: EU/1/20/1524 20210326
2443246	301137	Netherlands		PRODUCT NAME: ICOSAPENT-ETHYL; REGISTRATION NO/DATE: EU/1/20/1524 20210329
2022495	21C1045	France		PRODUCT NAME: ICOSAPENT ETHYL; REGISTRATION NO/DATE: EU/1/20/1524 20210329