Icosapent ethyl - Generic Drug Details
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What are the generic 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, 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 forty-eight patent family members in forty-five countries.
There are six drug master file entries for icosapent ethyl. Thirteen suppliers are listed for this compound.
Summary for icosapent ethyl
International Patents: | 348 |
US Patents: | 70 |
Tradenames: | 2 |
Applicants: | 9 |
NDAs: | 9 |
Drug Master File Entries: | 6 |
Finished Product Suppliers / Packagers: | 13 |
Raw Ingredient (Bulk) Api Vendors: | 60 |
Clinical Trials: | 17 |
Patent Applications: | 2,462 |
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
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 | ⤷ Try a Trial | ⤷ Try a Trial |
Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-002 | Feb 16, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Russian Federation | 2686315 | СПОСОБЫ ЛЕЧЕНИЯ ГИПЕРТРИГЛИЦЕРИДЕМИИ (METHODS OF TREATMENT OF HYPERTRIGLYCERIDEMIA) | ⤷ Try a Trial |
Slovenia | 2596786 | ⤷ Try a Trial | |
Australia | 2023200783 | Methods of reducing the risk of cardiovascular events in a subject | ⤷ Try a Trial |
Canada | 3008079 | UTILISATION D'ACIDE ICOSAPENTANOIQUE POUR LE TRAITEMENT DE L'HYPERTRIGLYCERIDEMIE (USE OF EICOSAPENTAENOIC ACID TO TREAT HYPERTRIGLYCERIDEMIA) | ⤷ Try a Trial |
Singapore | 11202102872Q | METHODS OF REDUCING THE RISK OF CARDIOVASCULAR EVENTS IN A SUBJECT | ⤷ Try a Trial |
Brazil | PI1014405 | composições farmacêuticas compreendendo epa e um agente cardiovascular e métodos de seu uso | ⤷ Try a Trial |
Singapore | 10201708950X | COMPOSITIONS AND METHODS FOR LOWERING TRIGLYCERIDES WITHOUT RAISING LDL-C LEVELS IN A SUBJECT ON CONCOMITANT STATIN THERAPY | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for icosapent ethyl
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2443246 | 39/2021 | Austria | ⤷ Try a Trial | PRODUCT NAME: ICOSAPENT-ETHYL (= EICOSAPENTAENSAEUREETHYLESTER,; REGISTRATION NO/DATE: EU/1/20/1524 20210329 |
2443246 | 132021000000156 | Italy | ⤷ Try a Trial | PRODUCT NAME: ICOSAPENT ETILE(VAZKEPA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1524, 20210329 |
2022495 | 122021000058 | Germany | ⤷ Try a Trial | PRODUCT NAME: ICOSAPENT-ETHYL; REGISTRATION NO/DATE: EU/1/20/1524 20210326 |
2022495 | 132021000000154 | Italy | ⤷ Try a Trial | PRODUCT NAME: ICOSAPENT ETILE(VAZKEPA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1524, 20210329 |
2443246 | 301137 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ICOSAPENT-ETHYL; REGISTRATION NO/DATE: EU/1/20/1524 20210329 |
2443246 | C20210022 00395 | Estonia | ⤷ Try a Trial | PRODUCT NAME: IKOSAPENTETUEUEL;REG NO/DATE: EU/1/20/1524 29.03.2021 |
2443246 | 2021042 | Norway | ⤷ Try a Trial | PRODUCT NAME: IKOSAPENTETYL; REG. NO/DATE: EU/1/20/1524 20210408 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |