Tag: Hatch-Waxman Act
Explore the Hatch-Waxman Act: the federal law that balances drug innovation with affordable generics through the ANDA process and the Orange Book.
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Regulatory exclusivity provides government-granted market protection for pharmaceuticals beyond patents. It ensures innovators have commercial time even if patents expire during development. Key types include 5-year NCE, 12-year biologics, and 7-year orphan drug exclusivity. Differences exist between U.S. and EU rules, with significant economic impacts on drug pricing and competition.
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.
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.