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Last Updated: November 25, 2024

CLOPIDOGREL BISULFATE - Generic Drug Details


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

Clopidogrel bisulfate is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Acme Labs, Actavis Totowa, Alkem Labs Ltd, Amneal Pharms, Ani Pharms, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Macleods Pharms Ltd, MSN, Polygen Pharms, Prinston Inc, Rising, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Industries, Teva, Torrent Pharms Ltd, Zydus Lifesciences, and Sanofi Aventis Us, and is included in twenty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are forty-five drug master file entries for clopidogrel bisulfate. Forty-three suppliers are listed for this compound.

Drug Prices for CLOPIDOGREL BISULFATE

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Drug Sales Revenue Trends for CLOPIDOGREL BISULFATE

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Recent Clinical Trials for CLOPIDOGREL BISULFATE

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SponsorPhase
Joint Stock Company "Farmak"Phase 1
Xinhua Hospital, Shanghai Jiao Tong University School of MedicineN/A
The First Affiliated Hospital with Nanjing Medical UniversityPhase 4

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Pharmacology for CLOPIDOGREL BISULFATE
Paragraph IV (Patent) Challenges for CLOPIDOGREL BISULFATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PLAVIX Tablets clopidogrel bisulfate 300 mg 020839 1 2009-03-04

US Patents and Regulatory Information for CLOPIDOGREL BISULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hetero Labs Ltd V CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 205345-001 Aug 4, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal Pharms CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 203751-001 Apr 11, 2014 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 204359-001 Feb 2, 2017 AB RX 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 CLOPIDOGREL BISULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us PLAVIX clopidogrel bisulfate TABLET;ORAL 020839-002 Sep 20, 2007 ⤷  Sign Up ⤷  Sign Up
Sanofi Aventis Us PLAVIX clopidogrel bisulfate TABLET;ORAL 020839-002 Sep 20, 2007 ⤷  Sign Up ⤷  Sign Up
Sanofi Aventis Us PLAVIX clopidogrel bisulfate TABLET;ORAL 020839-001 Nov 17, 1997 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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