Tag: Hatch-Waxman Act
Hatch-Waxman Act: How It Shaped Generic Drug Access in the U.S.
The Hatch-Waxman Act created the modern system for generic drug approval in the U.S., balancing innovation and affordability. It cut drug costs by billions while enabling faster generic entry-though patent abuses now threaten its effectiveness.
Effective Patent Life: Why Market Exclusivity in Pharmaceuticals Is Shorter Than You Think
Effective patent life in pharmaceuticals is often just 10-13 years, not 20, due to lengthy drug development and regulatory delays. Secondary patents and exclusivities extend monopolies beyond legal limits.
When Do Drug Patents Expire? Understanding the 20-Year Term and Real-World Timelines
Drug patents last 20 years from filing, but most drugs have only 7-12 years of market exclusivity due to lengthy approval processes. Patent extensions, regulatory exclusivities, and litigation shape when generics can enter.