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Details for New Drug Application (NDA): 202057
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.
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: | RX | Dosage: | CAPSULE;ORAL | Strength | 1GM | ||||
| Approval Date: | Jul 26, 2012 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Jan 27, 2020 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | Start Trial | Patent Expiration: | Feb 9, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA | ||||||||
| Patent: | Start Trial | Patent Expiration: | Feb 9, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA | ||||||||
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