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Last Updated: August 14, 2020

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Prasugrel hydrochloride - Generic Drug Details

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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 two branded drugs marketed by Eli Lilly And Co, Accord Hlthcare, Amneal Pharms, Aurobindo Pharma Ltd, Hec Pharm, Mylan, Panacea Biotec Ltd, and Uspharma Windlas, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for prasugrel hydrochloride. Thirteen suppliers are listed for this compound.

Recent Clinical Trials for prasugrel hydrochloride

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

SponsorPhase
University of MilanPhase 3
Azienda Ospedaliera Universitaria Integrata VeronaPhase 3
AdvicePharma GroupPhase 4

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 NDA Submissiondate
EFFIENT TABLET;ORAL prasugrel hydrochloride 022307 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
Uspharma Windlas PRASUGREL prasugrel hydrochloride TABLET;ORAL 205790-001 Oct 16, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms PRASUGREL prasugrel hydrochloride TABLET;ORAL 205913-001 Jun 19, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Eli Lilly And Co EFFIENT prasugrel hydrochloride TABLET;ORAL 022307-002 Jul 10, 2009 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Hec Pharm PRASUGREL prasugrel hydrochloride TABLET;ORAL 206021-002 Jan 16, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare PRASUGREL prasugrel hydrochloride TABLET;ORAL 205987-001 Feb 2, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd PRASUGREL prasugrel hydrochloride TABLET;ORAL 205888-001 Oct 16, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
>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
Eli Lilly And Co EFFIENT prasugrel hydrochloride TABLET;ORAL 022307-001 Jul 10, 2009   Start Trial   Start Trial
Eli Lilly And Co EFFIENT prasugrel hydrochloride TABLET;ORAL 022307-002 Jul 10, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Baxter
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Dow

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