Generic Drug
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.
示例
- 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.