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Last Updated: April 27, 2024

PRASUGREL HYDROCHLORIDE Drug Patent Profile


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When do Prasugrel Hydrochloride patents expire, and when can generic versions of Prasugrel Hydrochloride launch?

Prasugrel Hydrochloride is a drug marketed by Unichem and is included in one NDA.

The generic ingredient in PRASUGREL HYDROCHLORIDE 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 Hydrochloride

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

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Drug patent expirations by year for PRASUGREL HYDROCHLORIDE
Recent Clinical Trials for PRASUGREL HYDROCHLORIDE

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

SponsorPhase
Giampiero VizzariPhase 3
Giorgio QuadriPhase 3
Ferdinando VarbellaPhase 3

See all PRASUGREL HYDROCHLORIDE clinical trials

Pharmacology for PRASUGREL HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for PRASUGREL HYDROCHLORIDE
Paragraph IV (Patent) Challenges for PRASUGREL HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EFFIENT Tablets prasugrel hydrochloride 5 mg and 10 mg 022307 17 2013-07-10

US Patents and Regulatory Information for PRASUGREL HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Unichem PRASUGREL HYDROCHLORIDE prasugrel hydrochloride TABLET;ORAL 213315-001 Aug 28, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Unichem PRASUGREL HYDROCHLORIDE prasugrel hydrochloride TABLET;ORAL 213315-002 Aug 28, 2023 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 HYDROCHLORIDE

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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