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Last Updated: April 28, 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, 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 forty-nine patent family members in forty-five countries.

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

Summary for ICOSAPENT ETHYL

International Patents:	349
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:	2,462
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
Ascent Pharms Inc	ICOSAPENT ETHYL	icosapent ethyl	CAPSULE;ORAL	216811-001	Dec 7, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Dr Reddys	ICOSAPENT ETHYL	icosapent ethyl	CAPSULE;ORAL	209499-002	Mar 8, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-001	Jul 26, 2012	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus	ICOSAPENT ETHYL	icosapent ethyl	CAPSULE;ORAL	217656-001	Apr 20, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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	⤷ Try a Trial	⤷ Try a Trial
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017	⤷ Try a Trial	⤷ Try a Trial
>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
Brazil	PI1011876	"composição farmacêutica estável e métodos de uso da mesma"	⤷ Try a Trial
Philippines	12015500407	METHODS OF TREATING HYPERTRIGLYCERIDEMIA	⤷ Try a Trial
China	113332269	降低受试者的心血管事件的风险的方法 (Methods of reducing risk of cardiovascular events in subject)	⤷ Try a Trial
Malaysia	173616	COMPOSITIONS AND METHODS FOR LOWERING TRIGLYCERIDES	⤷ Try a Trial
Canada	2759284	COMPOSITION PHARMACEUTIQUE STABLE ET SES PROCEDES D'UTILISATION (STABLE PHARMACEUTICAL COMPOSITION AND METHODS OF USING SAME)	⤷ Try a Trial
China	111840268	在接受抑制素治疗的受试者中降低心血管事件风险的方法 (Methods of reducing risk of cardiovascular event in subject on statin therapy)	⤷ Try a Trial
>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
2443246	LUC00226	Luxembourg	⤷ Try a Trial	PRODUCT NAME: ICOSAPENT ETHYL; AUTHORISATION NUMBER AND DATE: EU/1/20/1524 20210329
2443246	2021C/538	Belgium	⤷ Try a Trial	PRODUCT NAME: VAZKEPA - ICOSAPENT ETHYL; AUTHORISATION NUMBER AND DATE: EU/1/20/1524 20210329
2022495	21C1045	France	⤷ Try a Trial	PRODUCT NAME: ICOSAPENT ETHYL; REGISTRATION NO/DATE: EU/1/20/1524 20210329
2443246	301137	Netherlands	⤷ Try a Trial	PRODUCT NAME: ICOSAPENT-ETHYL; REGISTRATION NO/DATE: EU/1/20/1524 20210329
2022495	C202130051	Spain	⤷ Try a Trial	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
2022495	122021000058	Germany	⤷ Try a Trial	PRODUCT NAME: ICOSAPENT-ETHYL; REGISTRATION NO/DATE: EU/1/20/1524 20210326
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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