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Zocor generic

Complete generic competition for Zocor (simvastatin): 13 approved generics across manufacturers, 0 filed under FDA review. 2 active patents remain. Sourced from FDA Orange Book + USPTO.

13 approved generics 2 active patents

About Zocor

Zocor (simvastatin) — originally marketed by Merck & Co.. Class: HMG-CoA Reductase Inhibitor [EPC].

Approved generic versions (13)

GenericManufacturerPhaseFirst approvalCountry
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)

Expired patents (0)

No expired patents tracked.

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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