Generic Drug

General

A pharmaceutical product equivalent to a brand-name drug in dosage form, strength, route, quality, and intended use. Must demonstrate bioequivalence. Typically 80-85% cheaper than the branded version.

Exemplos

  • Generic atorvastatin vs Lipitor
  • Hatch-Waxman Act (1984)
  • Orange Book listings

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A pharmaceutical product equivalent to a brand-name drug in dosage form, strength, route, quality, and intended use. Must demonstrate bioequivalence. Typically 80-85% cheaper than the branded version.