FDA Orange Book · active-ingredient family
Clopidogrel bisulfate
Clopidogrel bisulfate: 1 brand, 25 generics; first approved Nov 17, 1997; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 25 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
25
Listed patents
0
Presentations
36
Brand (NDA) products
Originator applications
- PLAVIXRLDSANOFI AVENTIS USNDA 02083919972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE TABLET ORAL Rx AB EQ 300MG BASE TABLET ORAL Rx AB
Generic (ANDA) products (25)
Abbreviated applications
- CLOPIDOGREL BISULFATEMSNANDA 2153882024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE TABLET ORAL Rx AB - CLOPIDOGREL BISULFATEDR REDDYS LABS LTDANDA 09102320242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE TABLET ORAL Rx AB EQ 75MG BASE TABLET ORAL Rx AB - CLOPIDOGREL BISULFATEALKEM LABS LTDANDA 2036322023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE TABLET ORAL Rx AB - CLOPIDOGREL BISULFATEHETERO LABS LTD VANDA 20534520232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE TABLET ORAL Rx AB EQ 300MG BASE TABLET ORAL Rx AB - CLOPIDOGREL BISULFATEPURACAP LABS BLUANDA 21335120202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE TABLET ORAL Rx AB EQ 300MG BASE TABLET ORAL Rx AB - CLOPIDOGREL BISULFATEPRINSTON INCANDA 20637620182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE TABLET ORAL Rx AB EQ 300MG BASE TABLET ORAL Rx AB - CLOPIDOGREL BISULFATERISINGANDA 2043592017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE TABLET ORAL Rx AB - CLOPIDOGREL BISULFATESCIEGEN PHARMSANDA 20416520142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE TABLET ORAL Rx AB EQ 300MG BASE TABLET ORAL Rx AB - CLOPIDOGREL BISULFATEAMNEAL PHARMSANDA 2037512014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE TABLET ORAL Rx AB - CLOPIDOGREL BISULFATEMACLEODS PHARMS LTDANDA 2029282014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE TABLET ORAL Rx AB - CLOPIDOGREL BISULFATESUN PHARM INDUSTRIESANDA 0781332013
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE TABLET ORAL Discontinued — - CLOPIDOGREL BISULFATEACTAVIS TOTOWAANDA 0903072013
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE TABLET ORAL Discontinued — - CLOPIDOGREL BISULFATEACCORD HLTHCAREANDA 20292520132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE TABLET ORAL Discontinued — EQ 300MG BASE TABLET ORAL Discontinued — - CLOPIDOGREL BISULFATEZYDUS LIFESCIENCESANDA 2016862012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE TABLET ORAL Discontinued — - CLOPIDOGREL BISULFATECHARTWELL RXANDA 20226620122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE TABLET ORAL Discontinued — EQ 300MG BASE TABLET ORAL Discontinued — - CLOPIDOGREL BISULFATEACME LABSANDA 0780042012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE TABLET ORAL Rx AB - CLOPIDOGREL BISULFATEANI PHARMSANDA 0906252012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE TABLET ORAL Discontinued — - CLOPIDOGREL BISULFATEANI PHARMSANDA 0912162012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE TABLET ORAL Discontinued — - CLOPIDOGREL BISULFATEAPOTEX INCANDA 07627420122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE TABLET ORAL Rx AB EQ 300MG BASE TABLET ORAL Rx AB - CLOPIDOGREL BISULFATEAUROBINDO PHARMA LTDANDA 0905402012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE TABLET ORAL Rx AB - CLOPIDOGREL BISULFATERISINGANDA 07766520122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE TABLET ORAL Discontinued — EQ 300MG BASE TABLET ORAL Discontinued — - CLOPIDOGREL BISULFATESUN PHARMANDA 0904942012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE TABLET ORAL Discontinued — - CLOPIDOGREL BISULFATETEVAANDA 0769992012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE TABLET ORAL Rx AB - CLOPIDOGREL BISULFATETORRENT PHARMS LTDANDA 0908442012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE TABLET ORAL Rx AB - CLOPIDOGREL BISULFATEDR REDDYSANDA 0762732008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE TABLET ORAL Rx AB
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
29 yr 2 mo ago
Most recent approval
2 yr ago
Approvals span 1997–2024 across 26 FDA applications.
Brand (NDA) 14%
Generic (ANDA) 2596%
Clopidogrel bisulfate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
