Tag: Hatch-Waxman Act

Evelyn Markham Feb 3 2026

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

First generic approval is the key to slashing drug prices in the U.S. It gives the first company to launch a generic version of a brand-name drug 180 days of exclusivity - driving massive savings for patients and the healthcare system.

Evelyn Markham Jan 16 2026

30-Month Stay: How Patent Litigation Delays Generic Drug Approval

The 30-month stay under the Hatch-Waxman Act lets brand drug companies delay generic approval by triggering patent lawsuits. While designed to protect innovation, it's often used to extend monopolies, costing consumers billions annually.

Evelyn Markham Nov 22 2025

Generic Patent Case Law: Landmark Court Decisions That Shape Drug Prices

Landmark court decisions in generic patent law shape how quickly affordable drugs reach patients. From Amgen v. Sanofi to Amarin v. Hikma, these rulings define the line between innovation and competition-and directly impact drug prices.