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Last Updated: June 11, 2024

ICOSAPENT ETHYL - Generic Drug Details

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What are the generic drug sources for icosapent ethyl and what is the scope of patent protection?

Icosapent ethyl is the generic ingredient in two branded drugs marketed by Apotex, Ascent Pharms Inc, Dr Reddys, Hikma, Humanwell Puracap, Strides Pharma, Teva Pharms Usa, Zydus Lifesciences, and Amarin Pharms, and is included in nine NDAs. There are seventy 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 fifty-six patent family members in forty-six countries.

There are six drug master file entries for icosapent ethyl. Fifteen suppliers are listed for this compound.

Summary for ICOSAPENT ETHYL

International Patents:	356
US Patents:	70
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	17
Patent Applications:	2,164
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
HLS Therapeutics, Inc	Phase 4
Unity Health Toronto	Phase 4

See all ICOSAPENT ETHYL clinical trials

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

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Glossary

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

Expired US Patents for ICOSAPENT ETHYL

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

EU/EMA Drug Approvals for ICOSAPENT ETHYL

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for ICOSAPENT ETHYL

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Country	Patent Number	Title	Estimated Expiration
South Korea	101383006		⤷ Sign Up
New Zealand	595852	Stable pharmaceutical composition comprising ethyl eicosapentaenoate	⤷ Sign Up
Japan	5809115		⤷ Sign Up
Russian Federation	2489145	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ЕРА И СЕРДЕЧНО-СОСУДИСТОЕ СРЕДСТВО, И СПОСОБ ИХ ПРИМЕНЕНИЯ (PHARMACEUTICAL COMPOSITIONS CONTAINING EPA AND CARDIOVASCULAR DRUG, AND METHOD FOR PREPARING THEM)	⤷ Sign Up
Mexico	2015000138	METODOS PARA REDUCIR RIESGO DE EVENTO CARDIOVASCULAR EN SUJETO CON TERAPIA CON ESTATINA. (METHODS OF REDUCING THE RISK OF A CARDIOVASCULAR EVENT IN A SUBJECT ON STATIN THERAPY.)	⤷ Sign Up
Denmark	2395991		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ICOSAPENT ETHYL

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2022495	C202130051	Spain	⤷ Sign Up	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	LUC00226	Luxembourg	⤷ Sign Up	PRODUCT NAME: ICOSAPENT ETHYL; AUTHORISATION NUMBER AND DATE: EU/1/20/1524 20210329
2022495	21C1045	France	⤷ Sign Up	PRODUCT NAME: ICOSAPENT ETHYL; REGISTRATION NO/DATE: EU/1/20/1524 20210329
2443246	21C1046	France	⤷ Sign Up	PRODUCT NAME: ICOSAPENT ETHYL; NAT. REGISTRATION NO/DATE: EU/1/20/1524 20210329; FIRST REGISTRATION: - EU/1/20/1524 20210329
2443246	CA 2021 00036	Denmark	⤷ Sign Up	PRODUCT NAME: ICOSAPENT ETHYL; REG. NO/DATE: EU/1/20/1524 20210329
2443246	301137	Netherlands	⤷ Sign Up	PRODUCT NAME: ICOSAPENT-ETHYL; REGISTRATION NO/DATE: EU/1/20/1524 20210329
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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