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Last Updated: August 8, 2020

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Clopidogrel bisulfate - Generic Drug Details

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What are the generic 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, Amneal Pharms, Ani Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Cadila, Celltrion, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Graviti Pharms, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Industries, Teva, Torrent Pharms Ltd, and Sanofi Aventis Us, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are fifty-four drug master file entries for clopidogrel bisulfate. Forty-two 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
Xinhua Hospital, Shanghai Jiao Tong University School of MedicineN/A
The First Affiliated Hospital with Nanjing Medical UniversityPhase 4
CKD Pharmaceutical LimitedPhase 4

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Pharmacology for clopidogrel bisulfate
Paragraph IV (Patent) Challenges for CLOPIDOGREL BISULFATE
Tradename Dosage Ingredient NDA Submissiondate
PLAVIX TABLET;ORAL clopidogrel bisulfate 020839 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
Celltrion CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 202266-001 Aug 14, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 091023-001 May 17, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 090540-001 May 17, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 090625-001 May 17, 2012 DISCN 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 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   Start Trial   Start Trial
Sanofi Aventis Us PLAVIX clopidogrel bisulfate TABLET;ORAL 020839-001 Nov 17, 1997   Start Trial   Start Trial
Sanofi Aventis Us PLAVIX clopidogrel bisulfate TABLET;ORAL 020839-001 Nov 17, 1997   Start Trial   Start Trial
Sanofi Aventis Us PLAVIX clopidogrel bisulfate TABLET;ORAL 020839-001 Nov 17, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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