You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 2, 2024

Prasugrel hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for prasugrel hydrochloride and what is the scope of freedom to operate?

Prasugrel hydrochloride is the generic ingredient in three branded drugs marketed by Cosette, Accord Hlthcare, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Dr Reddys, Hec Pharm, Lupin Ltd, Mylan, Panacea, and Unichem, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for prasugrel hydrochloride. Nine suppliers are listed for this compound.

Recent Clinical Trials for prasugrel hydrochloride

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

SponsorPhase
Antonio MicariPhase 3
Greca ZandaPhase 3
Giampiero VizzariPhase 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
Hec Pharm PRASUGREL prasugrel hydrochloride TABLET;ORAL 206021-002 Jan 16, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lupin Ltd PRASUGREL prasugrel hydrochloride TABLET;ORAL 205930-002 Jan 9, 2023 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chartwell Rx PRASUGREL prasugrel hydrochloride TABLET;ORAL 205790-001 Oct 16, 2017 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys PRASUGREL prasugrel hydrochloride TABLET;ORAL 205926-001 Jul 7, 2020 DISCN No No ⤷  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 prasugrel hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cosette EFFIENT prasugrel hydrochloride TABLET;ORAL 022307-001 Jul 10, 2009 ⤷  Sign Up ⤷  Sign Up
Cosette EFFIENT prasugrel hydrochloride TABLET;ORAL 022307-001 Jul 10, 2009 ⤷  Sign Up ⤷  Sign Up
Cosette EFFIENT prasugrel hydrochloride TABLET;ORAL 022307-002 Jul 10, 2009 ⤷  Sign Up ⤷  Sign Up
Cosette EFFIENT prasugrel hydrochloride TABLET;ORAL 022307-001 Jul 10, 2009 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.