Tag: Hatch-Waxman Act

9 Mar 2026
by Michael Brown
15 Comments

Paragraph IV Certifications: How Generic Drugs Challenge Patents Early

Paragraph IV certifications let generic drug makers challenge brand patents before launch, saving consumers billions. This legal tool under the Hatch-Waxman Act drives competition, lowers prices, and reshapes the U.S. drug market.

3 Jan 2026
by Michael Brown
13 Comments

First Generic Approval: Why It Matters and What It Means for Drug Prices and Access

First generic approval gives the first company to launch a generic drug 180 days of exclusivity, driving down prices by up to 90%. Learn how this FDA process saves billions and why it matters for your prescriptions.