Tag: 180-day exclusivity

The first generic drug company to file an ANDA with a Paragraph IV certification gets 180 days of exclusive market rights under the Hatch-Waxman Act. This incentive drives competition but has been exploited to delay generic access.

Paragraph IV certifications let generic drug makers legally challenge brand-name patents before market entry. This Hatch-Waxman tool drives competition, lowers drug prices, and offers 180-day exclusivity to the first challenger.