Tag: Hatch-Waxman Act

The FDA's 180-day exclusivity gives the first generic drug applicant a temporary monopoly to encourage patent challenges. But delays and loopholes often block competition, raising drug costs. Here's how it really works - and why reform is coming.

Drug patents last 20 years from filing, but most drugs lose exclusivity in 7-12 years due to development delays. Learn how patent extensions, FDA exclusivity, and litigation shape when generics actually enter the market.

The ANDA process is the legal pathway for generic drug approval in the U.S., requiring strict proof of bioequivalence, identical active ingredients, and compliance with FDA manufacturing standards under the Hatch-Waxman Act.