Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Harvard Business School
Merck
Dow
McKinsey
Mallinckrodt
Baxter

Last Updated: November 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202057

See Plans and Pricing

« Back to Dashboard

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 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:25
Generic Entry Opportunity Date for 202057
Generic Entry Date for 202057*:
Constraining patent/regulatory exclusivity:
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
Patent:  Start TrialPatent Expiration:Jan 27, 2020Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Feb 9, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Patent:  Start TrialPatent Expiration:Feb 9, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
Boehringer Ingelheim
Dow
Mallinckrodt
McKesson
McKinsey

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.