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Last Updated: March 29, 2024

Prasugrel - Generic Drug Details


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Summary for prasugrel
Recent Clinical Trials for prasugrel

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Giorgio QuadriPhase 3
Ferdinando VarbellaPhase 3
Azienda Ospedaliera Universitaria Policlinico "G. Martino"Phase 3

See all prasugrel clinical trials

US Patents and Regulatory Information for prasugrel

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hec Pharm PRASUGREL prasugrel hydrochloride TABLET;ORAL 206021-002 Jan 16, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Panacea PRASUGREL prasugrel hydrochloride TABLET;ORAL 205897-001 Oct 16, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys PRASUGREL prasugrel hydrochloride TABLET;ORAL 205926-001 Jul 7, 2020 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Rx PRASUGREL prasugrel hydrochloride TABLET;ORAL 205790-001 Oct 16, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for prasugrel

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Mylan Pharmaceuticals Limited Prasugrel Mylan prasugrel EMEA/H/C/004644
Prasugrel Mylan, co administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (i.e. unstable angina, non-ST segment elevation myocardial infarction [UA/NSTEMI] or ST segment elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).
Authorised yes no no 2018-05-15
Substipharm Efient prasugrel EMEA/H/C/000984
Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome (i.e. unstable angina, non-ST-segment-elevation myocardial infarction [UA / NSTEMI] or ST-segment-elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).
Authorised no no no 2009-02-24
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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