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Last Updated: February 1, 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 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:RXDosage:CAPSULE;ORALStrength1GM
Approval Date:Jul 26, 2012TE:ABRLD: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 PricingPatent Expiration:Apr 29, 2030Product 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 PricingPatent Expiration:Apr 29, 2030Product 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 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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