How does the Hatch-Waxman Amendment encourage the generic drug market?

The Hatch-Waxman Amendment created an abbreviated approval pathway for generic drugs shown to be therapeutically equivalent to brand-name drugs. This lets generic manufacturers rely on existing evidence of the brand drug’s safety and effectiveness instead of repeating the full approval process, reducing time and cost. The Orange Book supports the system by listing patent information, but the streamlined approval process is the main way the law encourages generic competition.

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