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 sixty-nine 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. Seven 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:	69

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
Regulatory Exclusivity Expiration:	Dec 13, 2022
Regulatory Exclusivity Use:	ADJUNCT TO MAX TOLERATED STATIN TX TO REDUCE RISK OF MI, STROKE, CORONARY REVASCULARIZATION, & UNSTABLE ANGINA REQUIRING HOSPITALIZATION IN ADULTS W/ ELEVATED TG LEVELS & ESTABLISHED CV DISEASE OR DIABETES MELLITUS & 2+ RISK FACTORS FOR CV DISEASE
Patent:	See Plans and Pricing	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:	See Plans and Pricing	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

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	See Plans and Pricing	See Plans and Pricing
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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