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Last Updated: April 22, 2024

PRASUGREL Drug Patent Profile


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Which patents cover Prasugrel, and when can generic versions of Prasugrel launch?

Prasugrel is a drug marketed by Accord Hlthcare, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Dr Reddys, Hec Pharm, Lupin Ltd, Mylan, Panacea, and Unichem. and is included in ten NDAs.

The generic ingredient in PRASUGREL is prasugrel hydrochloride. There are nineteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the prasugrel hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Prasugrel

A generic version of PRASUGREL was approved as prasugrel hydrochloride by UNICHEM on August 28th, 2023.

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Drug patent expirations by year for PRASUGREL
Drug Prices for PRASUGREL

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Recent Clinical Trials for PRASUGREL

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

See all PRASUGREL clinical trials

Pharmacology for PRASUGREL

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
Accord Hlthcare PRASUGREL prasugrel hydrochloride TABLET;ORAL 205987-001 Feb 2, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Panacea PRASUGREL prasugrel hydrochloride TABLET;ORAL 205897-002 Oct 16, 2017 AB RX 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
Amneal Pharms PRASUGREL prasugrel hydrochloride TABLET;ORAL 205913-002 Jun 19, 2018 AB RX 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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