Last reviewed · How we verify
Zocor generic
About Zocor
Zocor (simvastatin) — originally marketed by Merck & Co.. Class: HMG-CoA Reductase Inhibitor [EPC].
Approved generic versions (13)
| Generic | Manufacturer | Phase | First approval | Country |
|---|---|---|---|---|
| Simvastatin plus ticagrelor | Federal University of São Paulo | marketed | ||
| Simvastatin 40mg | Marc Goodman | marketed | ||
| Simvastatin or Atorvastatin | Hospital Arnau de Vilanova | marketed | ||
| Simvastatin combined with Amlodipine besylate | Third Military Medical University | marketed | ||
| Simvastatin 80mg | Helsinki University Central Hospital | marketed | ||
| simvastatin tablets | Federico II University | marketed | ||
| Simvastatin and micronized trans-resveratrol | Poznan University of Medical Sciences | marketed | ||
| Simvastatin 20mg | University of Oxford | marketed | ||
| Simvastatin/Ezetimibe | dr.Frank L.J. Visseren | marketed | ||
| Simvastatin plus clopidogrel | Federal University of São Paulo | marketed | ||
| Simvastatin (Zocor) | New York State Psychiatric Institute | marketed | ||
| Simvastatin-Methylcellulose | University of Nebraska | marketed | ||
| simvastatin and ezetimibe | UMC Utrecht | marketed |
Originator patent timeline
Active patents (2)
- —
9597289· Formulation · US - —
10300041· Formulation · US
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.