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Last Updated: September 19, 2020

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CLOPIDOGREL BISULFATE Drug Profile

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Which patents cover Clopidogrel Bisulfate, and what generic alternatives are available?

Clopidogrel Bisulfate is a drug 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, Polygen Pharms, Prinston Inc, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Industries, Teva, and Torrent Pharms Ltd. and is included in twenty-two NDAs.

The generic ingredient in CLOPIDOGREL BISULFATE is clopidogrel bisulfate. There are fifty-four drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the clopidogrel bisulfate profile page.

US ANDA Litigation and Generic Entry Outlook for Clopidogrel Bisulfate

A generic version of CLOPIDOGREL BISULFATE was approved as clopidogrel bisulfate by DR REDDYS LABS INC on January 14th, 2008.

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Drug patent expirations by year for CLOPIDOGREL BISULFATE
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
Teva CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 076999-001 May 17, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Torrent Pharms Ltd CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 090844-001 May 17, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 202925-001 Mar 27, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 077665-001 May 17, 2012 DISCN No No   Start Trial   Start Trial   Start Trial
Sciegen Pharms Inc CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 204165-001 Sep 15, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 091216-001 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

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