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Last Updated: July 4, 2020

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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
Generic Entry 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:RXDosage:CAPSULE;ORALStrength1GM
Approval Date:Jul 26, 2012TE: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:  Start TrialPatent 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:  Start TrialPatent 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

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