Tag: FDA approval

January 9 2026

Paragraph IV Patent Challenges: How Generic Drug Makers Beat Brand Patents

Paragraph IV patent challenges let generic drug makers legally fight brand-name patents to speed up cheaper alternatives. This system, created by the Hatch-Waxman Act, saves billions annually and drives 90% of U.S. prescriptions. Here's how it works - and why it matters.

December 21 2025

Complex Generic Drugs: Why Some Products Are Harder to Approve by the FDA

Complex generic drugs face far tougher FDA approval hurdles than simple generics due to intricate formulations, delivery systems, and lack of clear guidance. Fewer than 15 have been approved since 2015, leaving patients without affordable options.