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VASCEPA Drug Profile
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» See Plans and PricingWhen 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 fifty-five patents protecting this drug and three Paragraph IV challenges.
This drug has two hundred and sixty-three patent family members in fifty countries.
The generic ingredient in VASCEPA is icosapent ethyl. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the icosapent ethyl profile page.
US ANDA Litigation and Generic Entry Outlook for Vascepa
A generic version of VASCEPA was approved as icosapent ethyl by HIKMA on May 21st, 2020.
Summary for VASCEPA
| International Patents: | 263 |
| US Patents: | 55 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 33 |
| Clinical Trials: | 10 |
| Patent Applications: | 215 |
| Drug Prices: | Drug price information for VASCEPA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VASCEPA |
| DailyMed Link: | VASCEPA at DailyMed |
Recent Clinical Trials for VASCEPA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Matinas BioPharma Nanotechnologies, Inc. | Phase 2 |
| Matinas Biopharma, Inc | Phase 2 |
| MB Clinical Research and Consulting LLC | Phase 2 |
Paragraph IV (Patent) Challenges for VASCEPA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| VASCEPA | CAPSULE;ORAL | icosapent ethyl | 202057 | 2017-08-29 |
| VASCEPA | CAPSULE;ORAL | icosapent ethyl | 202057 | 2016-07-26 |
US Patents and Regulatory Information for VASCEPA
| 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 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-002 | Feb 16, 2017 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-001 | Jul 26, 2012 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-001 | Jul 26, 2012 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-002 | Feb 16, 2017 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-001 | Jul 26, 2012 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| >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 | Start Trial | Start Trial |
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-002 | Feb 16, 2017 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VASCEPA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2570763 | Start Trial |
| China | 102625847 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2007142118 | Start Trial |
| Russian Federation | 2014131716 | Start Trial |
| Poland | 2443246 | Start Trial |
| Japan | 5134916 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VASCEPA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0253738 | 96C0009 | Belgium | Start Trial | PRODUCT NAME: CONCENTRE A 85 % D'OMEGA POLYINSATURES; QUANTITE CORRESPONDANT A :; ESTERS ETHYLIQUES D'ACIDE EICOSAPENTAENOIQUE (EPA) ET D'ACIDE DOCOSAHEXAENOIQUE (DHA); ALPHA TOCOPHEROL; NAT. REGISTRATION NO/DATE: NL 20819 19951002; FIRST REGISTRATION: |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
