Tag: patent litigation

11 June 2026 0 Comments Tessa Marley

Patent Litigation and Generic Entry: Why Disputes Delay Drug Launches

Explore how patent litigation under the Hatch-Waxman Act delays generic drug launches. We explain Paragraph IV certifications, patent thickets, and pay-for-delay settlements that keep drug prices high.

26 February 2026 12 Comments Tessa Marley

Tentative Approval and Litigation: How Generic Drug Makers Wait for Market Entry

Tentative approval lets generic drug makers get ahead in line for FDA approval, but they can't sell until patents expire. Patent litigation, strict deadlines, and regulatory moves determine who gets to market first-and who loses millions.