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. Eighteen suppliers are 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. Eighteen 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: | RX | Dosage: | CAPSULE;ORAL | Strength | 1GM | ||||
| Approval Date: | Jul 26, 2012 | TE: | AB | RLD: | Yes | ||||
| Patent: | 10,010,517 | Patent Expiration: | Apr 29, 2030 | Product 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: | 10,265,287 | Patent Expiration: | Apr 29, 2030 | Product 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: | 10,278,935 | Patent Expiration: | Jun 28, 2033 | Product 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 | 8,188,146 | ⤷ Get Started Free |
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-002 | Feb 16, 2017 | 8,188,146 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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