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Last Updated: November 30, 2022

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 Cosette, Accord Hlthcare, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Dr Reddys, Hec Pharm, Mylan, and Panacea, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

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

Recent Clinical Trials for prasugrel hydrochloride

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

SponsorPhase
University of Texas Southwestern Medical CenterPhase 2
Asan Medical CenterPhase 4
Abbott Medical DevicesPhase 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 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan PRASUGREL prasugrel hydrochloride TABLET;ORAL 205927-002 Jul 12, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amneal Pharms PRASUGREL prasugrel hydrochloride TABLET;ORAL 205913-002 Jun 19, 2018 BX RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cosette EFFIENT prasugrel hydrochloride TABLET;ORAL 022307-002 Jul 10, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Cosette EFFIENT prasugrel hydrochloride TABLET;ORAL 022307-002 Jul 10, 2009 See Plans and Pricing See Plans and Pricing
Cosette EFFIENT prasugrel hydrochloride TABLET;ORAL 022307-002 Jul 10, 2009 See Plans and Pricing See Plans and Pricing
Cosette EFFIENT prasugrel hydrochloride TABLET;ORAL 022307-001 Jul 10, 2009 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.