Details for New Drug Application (NDA): 202057
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The generic ingredient in VASCEPA is icosapent ethyl. There are twelve drug master file entries for this compound. Seven 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: | 69 |
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 | ||||
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: | See Plans and Pricing | 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: | See Plans and Pricing | 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 |
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 | See Plans and Pricing | See Plans and Pricing |
Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-002 | Feb 16, 2017 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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