ICOSAPENT ETHYL - Generic Drug Details
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What are the generic drug sources for icosapent ethyl and what is the scope of freedom to operate?
Icosapent ethyl
is the generic ingredient in two branded drugs marketed by Apotex, Ascent Pharms Inc, Dr Reddys, Hikma, Humanwell Puracap, Strides Pharma, Teva Pharms Usa, Zydus Lifesciences, and Amarin Pharms, and is included in nine NDAs. There are seventy patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Icosapent ethyl has three hundred and fifty-six patent family members in forty-six countries.
There are six drug master file entries for icosapent ethyl. Fifteen suppliers are listed for this compound.
Summary for ICOSAPENT ETHYL
International Patents: | 356 |
US Patents: | 70 |
Tradenames: | 2 |
Applicants: | 9 |
NDAs: | 9 |
Drug Master File Entries: | 6 |
Finished Product Suppliers / Packagers: | 15 |
Raw Ingredient (Bulk) Api Vendors: | 60 |
Clinical Trials: | 17 |
Patent Applications: | 2,164 |
Drug Prices: | Drug price trends for ICOSAPENT ETHYL |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ICOSAPENT ETHYL |
What excipients (inactive ingredients) are in ICOSAPENT ETHYL? | ICOSAPENT ETHYL excipients list |
DailyMed Link: | ICOSAPENT ETHYL at DailyMed |
Recent Clinical Trials for ICOSAPENT ETHYL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Cancer Institute (NCI) | Phase 1/Phase 2 |
Unity Health Toronto | Phase 4 |
Canadian Medical and Surgical Knowledge Translation Research Group | Phase 4 |
Paragraph IV (Patent) Challenges for ICOSAPENT ETHYL
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 ICOSAPENT ETHYL
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-001 | Jul 26, 2012 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Ascent Pharms Inc | ICOSAPENT ETHYL | icosapent ethyl | CAPSULE;ORAL | 216811-002 | Feb 16, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-002 | Feb 16, 2017 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-002 | Feb 16, 2017 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-001 | Jul 26, 2012 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-001 | Jul 26, 2012 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 ICOSAPENT ETHYL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-001 | Jul 26, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-002 | Feb 16, 2017 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ICOSAPENT ETHYL
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 ICOSAPENT ETHYL
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 111166736 | 在接受抑制素治疗的受试者中降低心血管事件风险的方法 (Methods of reducing risk of cardiovascular event in subject on statin therapy) | ⤷ Sign Up |
Spain | 2500063 | ⤷ Sign Up | |
European Patent Office | 4056176 | PROCÉDÉS DE RÉDUCTION DU RISQUE D'ÉVÉNEMENTS CARDIOVASCULAIRES CHEZ UN SUJET (METHODS OF REDUCING THE RISK OF CARDIOVASCULAR EVENTS IN A SUBJECT) | ⤷ Sign Up |
Australia | 2022200964 | COMPOSITIONS AND METHODS FOR LOWERING TRIGLYCERIDES WITHOUT RAISING LDL-C LEVELS | ⤷ Sign Up |
Russian Federation | 2723555 | СТАБИЛЬНЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ (STABLE PHARMACEUTICAL COMPOSITIONS AND METHODS OF USING THEM) | ⤷ Sign Up |
Luxembourg | C00226 | ⤷ Sign Up | |
Malaysia | 173616 | COMPOSITIONS AND METHODS FOR LOWERING TRIGLYCERIDES | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ICOSAPENT ETHYL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2443246 | 301137 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ICOSAPENT-ETHYL; REGISTRATION NO/DATE: EU/1/20/1524 20210329 |
2022495 | 132021000000154 | Italy | ⤷ Sign Up | PRODUCT NAME: ICOSAPENT ETILE(VAZKEPA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1524, 20210329 |
2443246 | 2021042 | Norway | ⤷ Sign Up | PRODUCT NAME: IKOSAPENTETYL; REG. NO/DATE: EU/1/20/1524 20210408 |
2443246 | CA 2021 00036 | Denmark | ⤷ Sign Up | PRODUCT NAME: ICOSAPENT ETHYL; REG. NO/DATE: EU/1/20/1524 20210329 |
2443246 | 2021C/538 | Belgium | ⤷ Sign Up | PRODUCT NAME: VAZKEPA - ICOSAPENT ETHYL; AUTHORISATION NUMBER AND DATE: EU/1/20/1524 20210329 |
2443246 | SPC/GB21/056 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ICOSAPENT ETHYL; REGISTERED: UK EU/1/20/1524(FOR NI) 20210329; UK FURTHER MA ON IPSUM 20210329 |
2443246 | 122021000056 | Germany | ⤷ Sign Up | PRODUCT NAME: VAZKEPA (ICOSAPENT ETHYL); REGISTRATION NO/DATE: EU/1/20/1524 20210326 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |