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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 twenty-five patents protecting this drug and two Paragraph IV challenges. Additional details are available on the VASCEPA profile page.

The generic ingredient in VASCEPA is icosapent ethyl. There are eleven 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 NDA: 202057

Tradename:
VASCEPA
Applicant:
Amarin Pharms
Ingredient:
icosapent ethyl
Patents:25

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1GM
Approval Date:Jul 26, 2012TE:RLD:Yes
Patent:8,188,146Patent Expiration:Jan 27, 2020Product Flag?YSubstance Flag?YDelist Request?
Patent:8,298,554Patent Expiration:Apr 29, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:8,617,593Patent Expiration:Apr 29, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF REDUCING TG LEVELS IN PATIENT ON STATIN THERAPY SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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