VASCEPA Drug Patent Profile
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When do Vascepa patents expire, and what generic alternatives are available?
Vascepa is a drug marketed by Amarin Pharms and is included in one NDA. There are sixty-three patents protecting this drug and two Paragraph IV challenges.
This drug has three hundred and ninety-six patent family members in forty-six countries.
The generic ingredient in VASCEPA is icosapent ethyl. There are twelve drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the icosapent ethyl profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Vascepa
A generic version of VASCEPA was approved as icosapent ethyl by HIKMA on May 21st, 2020.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for VASCEPA?
- What are the global sales for VASCEPA?
- What is Average Wholesale Price for VASCEPA?
Summary for VASCEPA
International Patents: | 396 |
US Patents: | 63 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 60 |
Clinical Trials: | 16 |
Patent Applications: | 1,538 |
Drug Prices: | Drug price information for VASCEPA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VASCEPA |
What excipients (inactive ingredients) are in VASCEPA? | VASCEPA excipients list |
DailyMed Link: | VASCEPA at DailyMed |


Recent Clinical Trials for VASCEPA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Cancer Institute (NCI) | Phase 1/Phase 2 |
University of Western Ontario, Canada | Phase 4 |
HLS Therapeutics, Inc | Phase 4 |
Paragraph IV (Patent) Challenges for VASCEPA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
VASCEPA | Capsules | icosapent ethyl | 500 mg | 202057 | 1 | 2017-08-29 |
VASCEPA | Capsules | icosapent ethyl | 1 g | 202057 | 4 | 2016-07-26 |
US Patents and Regulatory Information for VASCEPA
VASCEPA is protected by sixty-eight US patents.
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-002 | Feb 16, 2017 | AB | RX | Yes | No | 8,445,003 | ⤷ Try for Free | ⤷ Try for Free | |||
Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-002 | Feb 16, 2017 | AB | RX | Yes | No | 10,383,840 | ⤷ Try for Free | ⤷ Try for Free | |||
Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-001 | Jul 26, 2012 | AB | RX | Yes | Yes | 8,563,608 | ⤷ Try for Free | ⤷ Try for Free | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for VASCEPA
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 | ⤷ Try for Free |
Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-002 | Feb 16, 2017 | 8,188,146 | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for VASCEPA
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Amarin Pharmaceuticals Ireland Limited | Vazkepa | icosapent ethyl | EMEA/H/C/005398 Indicated to reduce cardiovascular risk as an adjunct to statin therapy. |
Authorised | no | no | no | 2021-03-26 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for VASCEPA
See the table below for patents covering VASCEPA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hong Kong | 1202795 | 含有 和心血管劑的藥物組合物以及使用其的方法 (PHARMACEUTICAL COMPOSITIONS COMPRISING EPA AND A CARDIOVASCULAR AGENT AND METHODS OF USING THE SAME EPA) | ⤷ Try for Free |
China | 1338929 | ⤷ Try for Free | |
Portugal | 3815684 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VASCEPA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2443246 | CR 2021 00036 | Denmark | ⤷ Try for Free | PRODUCT NAME: ICOSAPENT ETHYL; REG. NO/DATE: EU/1/20/1524 20210329 |
2443246 | PA2021522,C2443246 | Lithuania | ⤷ Try for Free | PRODUCT NAME: IKOZAPENTO ETILAS; REGISTRATION NO/DATE: EU/1/20/1524 20210326 |
2443246 | 132021000000156 | Italy | ⤷ Try for Free | PRODUCT NAME: ICOSAPENT ETILE(VAZKEPA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1524, 20210329 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for VASCEPA
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