Tag: Hatch-Waxman Act
Drug patents don't expire after exactly 20 years - most lose exclusivity in 7 to 14 years due to clinical trial delays and regulatory protections. Learn how patent extensions, exclusivity periods, and lawsuits delay generics and impact drug prices.
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Paragraph IV certification under the Hatch-Waxman Act allows generic drug makers to challenge brand-name patents and enter the market faster. Learn how this legal tool drives down drug prices and what makes it unique to the U.S.