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Cozaar generic
About Cozaar
Cozaar (losartan) — originally marketed by Merck & Co.. Class: ARB (Angiotensin II receptor blocker). First approved 1995-04-14.
Approved generic versions (12)
| Generic | Manufacturer | Phase | First approval | Country |
|---|---|---|---|---|
| Cozaar | Merck & Co. | marketed | 1995-01-01 | |
| Losartan (+) amlodipine | Organon and Co | marketed | ||
| Losartan and hydrochlorothiazide | University of Cambridge | marketed | ||
| losartan/amlodpine | University of Pavia | marketed | ||
| Losartan, Losartan and HCTZ, Amlodipine , Spironolactone | Biomedis International Ltd. | marketed | ||
| Losartan Tablets | Istituto Auxologico Italiano | marketed | ||
| Losartan and Amlodipine | Centro Universitario de Ciencias de la Salud, Mexico | marketed | ||
| Losartan and amlodipine and hydrochlorothiazide | Hotel Dieu de France Hospital | marketed | ||
| losartan and HCTZ | InVasc Therapeutics, Inc. | marketed | ||
| Losartan + Simvastatin | University of Pavia | marketed | ||
| losartan (drug) | Odense University Hospital | marketed | ||
| Losartan/amlodipine or losartan/hydrochlorothiazide | Yokohama City University Medical Center | 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.