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FDA Orange Book · active-ingredient family

Clopidogrel bisulfate

Clopidogrel bisulfate is approved as 1 brand and 25 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PLAVIX · NDA 020839

1

Brand (NDA)

25

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
PLAVIXRLD×2SANOFI AVENTIS USNDA 020839ABNov 17, 1997

Generic (ANDA) products (25)

ProductApplicantApplicationTEApproved
CLOPIDOGREL BISULFATEMSNANDA 215388ABSep 20, 2024
CLOPIDOGREL BISULFATE×2DR REDDYS LABS LTDANDA 091023ABAug 05, 2024
CLOPIDOGREL BISULFATEALKEM LABS LTDANDA 203632ABDec 08, 2023
CLOPIDOGREL BISULFATE×2HETERO LABS LTD VANDA 205345ABAug 04, 2023
CLOPIDOGREL BISULFATE×2PURACAP LABS BLUANDA 213351ABJul 17, 2020
CLOPIDOGREL BISULFATE×2PRINSTON INCANDA 206376ABMay 07, 2018
CLOPIDOGREL BISULFATERISINGANDA 204359ABFeb 02, 2017
CLOPIDOGREL BISULFATE×2SCIEGEN PHARMSANDA 204165ABSep 15, 2014
CLOPIDOGREL BISULFATEAMNEAL PHARMSANDA 203751ABApr 11, 2014
CLOPIDOGREL BISULFATEMACLEODS PHARMS LTDANDA 202928ABFeb 10, 2014
CLOPIDOGREL BISULFATESUN PHARM INDUSTRIESANDA 078133—Jun 10, 2013
CLOPIDOGREL BISULFATEACTAVIS TOTOWAANDA 090307—May 28, 2013
CLOPIDOGREL BISULFATE×2ACCORD HLTHCAREANDA 202925—Mar 27, 2013
CLOPIDOGREL BISULFATEZYDUS LIFESCIENCESANDA 201686—Oct 10, 2012
CLOPIDOGREL BISULFATE×2CHARTWELL RXANDA 202266—Aug 14, 2012
CLOPIDOGREL BISULFATEACME LABSANDA 078004ABMay 17, 2012
CLOPIDOGREL BISULFATEANI PHARMSANDA 090625—May 17, 2012
CLOPIDOGREL BISULFATEANI PHARMSANDA 091216—May 17, 2012
CLOPIDOGREL BISULFATE×2APOTEX INCANDA 076274ABMay 17, 2012
CLOPIDOGREL BISULFATEAUROBINDO PHARMA LTDANDA 090540ABMay 17, 2012
CLOPIDOGREL BISULFATE×2RISINGANDA 077665—May 17, 2012
CLOPIDOGREL BISULFATESUN PHARMANDA 090494—May 17, 2012
CLOPIDOGREL BISULFATETEVAANDA 076999ABMay 17, 2012
CLOPIDOGREL BISULFATETORRENT PHARMS LTDANDA 090844ABMay 17, 2012
CLOPIDOGREL BISULFATEDR REDDYSANDA 076273ABJan 14, 2008

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Clopidogrel bisulfate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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