Tag: FDA exclusivity

• Evan Moorehouse
• 12

Patent exclusivity and market exclusivity are two separate systems that protect new drugs. One is about invention, the other about data. Understanding the difference explains why some medicines stay expensive for years-even after patents expire.

• Cassius Thornfield
• 16

The 180-day exclusivity rule under the Hatch-Waxman Act gives the first generic drug challenger a temporary monopoly to incentivize patent challenges-but it often delays market entry for years, keeping prices high. Here's how it works and why it matters.