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Plavix generic
About Plavix
Plavix (clopidogrel) — originally marketed by Generic (originally Sanofi/BMS). Class: Thienopyridine antiplatelet agent. First approved 1997-11-17.
Approved generic versions (29)
| Generic | Manufacturer | Phase | First approval | Country |
|---|---|---|---|---|
| CLOPIDOGREL BESILATE | marketed | 2009-01-01 | ||
| CLOPIDOGREL BISULFATE | marketed | 1997-01-01 | ||
| Clopidogrel, Prasugrel, Ticagrelor | Centre hospitalier de l'Université de Montréal (CHUM) | marketed | ||
| Clopidogrel loading | Azienda Policlinico Umberto I | marketed | ||
| Clopidogrel 600 mg | Dong-A University | marketed | ||
| Clopidogrel reloading | University of Pecs | marketed | ||
| Clopidogrel with aspirin | University of Florida | marketed | ||
| Clopidogrel 150 mg | University of North Carolina, Chapel Hill | marketed | ||
| Clopidogrel + ASA + Bivalirudin | Juan J Badimon | marketed | ||
| Clopidogrel and proton pump inhibitors | National Taiwan University Hospital | marketed | ||
| Clopidogrel Tapering | Deutsches Herzzentrum Muenchen | marketed | ||
| Clopidogrel 75 | US Department of Veterans Affairs | marketed | ||
| clopidogrel and metoprolol | University of Oxford | marketed | ||
| clopidogrel/abciximab | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio | marketed | ||
| Clopidogrel+Aspirin | Seoul National University Hospital | marketed | ||
| clopidogrel napadisilate + aspirin | Seoul National University Hospital | marketed | ||
| clopidogrel (SR25990C) | Sanofi | marketed | ||
| clopidogrel combined with rivaroxaban arm | Shenyang Northern Hospital | marketed | ||
| clopidogrel + aspirin OR prasugrel + aspirin | Abbott Medical Devices | marketed | ||
| Clopidogrel & Aspirin, Prasugrel & Aspirin | Baim Institute for Clinical Research | marketed | ||
| Clopidogrel treatment | VA Office of Research and Development | marketed | ||
| clopidogrel bisulfate + aspirin | Seoul National University Hospital | marketed | ||
| Clopidogrel first | Ping-Yen Liu | marketed | ||
| clopidogrel treatment after bare metal stent implantation | Marco Valgimigli | marketed | ||
| Clopidogrel dose adjustment | University of Zagreb | marketed | ||
| Clopidogrel and aspirin dual-antiplatelet therapy | Harbin Medical University | marketed | ||
| Clopidogrel, cilostazol | Kyunghee University Medical Center | marketed | ||
| Clopidogrel only | Seung-Jung Park | marketed | ||
| Clopidogrel active metabolite | University of Florida | marketed |
Originator patent timeline
Active patents (0)
Expired patents (0)
How small-molecule generic approval works
Generic versions of small-molecule drugs are approved by the FDA via the Abbreviated New Drug Application (ANDA) pathway under the Hatch-Waxman Act of 1984. Sponsors must demonstrate bioequivalence (pharmacokinetic equivalence within tight bounds) and identical chemical composition — no clinical trials in patients are required. Approval typically takes 18-24 months.
This is different from biosimilars for biologic drugs, which use the more complex 351(k) BLA pathway and typically achieve smaller (15-35%) discounts vs the originator. Small-molecule generics typically launch at 60-80% discount, dropping to 85-95% within 2 years.
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Related
- Plavix full drug profile
- Biosimilar tracker (for biologic drugs)
- Patent cliff tracker
- Biosimilar vs generic — what's the difference?
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing