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Last Updated: October 12, 2024

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-three 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. Fifteen 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:63
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
Patent:⤷  Sign UpPatent 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:⤷  Sign UpPatent 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
Patent:⤷  Sign UpPatent Expiration:Jun 28, 2033Product 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 ⤷  Sign Up ⤷  Sign Up
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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