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Last Updated: November 29, 2023

Details for New Drug Application (NDA): 202057

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NDA 202057 describes VASCEPA, which is a drug marketed by Amarin Pharms and is included in one NDA. It is available from two suppliers. There are seventy patents protecting this drug and three Paragraph IV challenges. Additional details are available on the VASCEPA profile page.

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

Summary for 202057

Tradename:	VASCEPA
Applicant:	Amarin Pharms
Ingredient:	icosapent ethyl
Patents:	70

Suppliers and Packaging for NDA: 202057

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057	NDA	Amarin Pharma Inc.	52937-001	52937-001-04	4 CAPSULE in 1 BOTTLE (52937-001-04)
VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057	NDA	Amarin Pharma Inc.	52937-001	52937-001-20	120 CAPSULE in 1 BOTTLE (52937-001-20)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	1GM
Approval Date:	Jul 26, 2012	TE:	AB	RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Apr 29, 2030	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	USE OF VASCEPA TO LOWER TRIGLYCERIDES IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (ABOUT 200 MG/DL TO LESS THAN ABOUT 500 MG/DL) AND ON STATIN THERAPY
Patent:	⤷ Try a Trial	Patent Expiration:	Apr 29, 2030	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	USE OF VASCEPA TO REDUCE TRIGLYCERIDES IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (ABOUT 200 MG/DL TO LESS THAN ABOUT 500 MG/DL) AND ON ROSUVASTATIN THERAPY
Patent:	⤷ Try a Trial	Patent Expiration:	Jun 28, 2033	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CORONARY REVASCULARIZATION AND/OR UNSTABLE ANGINA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS (TG >= 150 MG/DL TO ABOUT 500 MG/DL)

Expired US Patents for NDA 202057

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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

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