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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 one supplier. There are fifty-five 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. One supplier is 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:	55

Generic Entry Opportunity Date for 202057

Constraining patent/regulatory exclusivity:

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

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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)

Paragraph IV (Patent) Challenges for 202057

Tradename	Dosage	Ingredient	NDA	Submissiondate
VASCEPA	CAPSULE;ORAL	icosapent ethyl	202057	2017-08-29
VASCEPA	CAPSULE;ORAL	icosapent ethyl	202057	2016-07-26

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	1GM
Approval Date:	Jul 26, 2012	TE:		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:		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:		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

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

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