Tag: Hatch-Waxman Act
Effective Patent Life: Why Market Exclusivity in Pharma Is Shorter Than You Think
Effective patent life in pharmaceuticals is often just 10-15 years, not 20, due to lengthy approval processes. Secondary patents and regulatory exclusivities extend monopolies, delaying generics and keeping prices high.
180-Day Exclusivity: How Patent Challenges Shape Generic Drug Market Entry
180-day exclusivity under the Hatch-Waxman Act incentivizes generic drug companies to challenge patents, but delays in commercialization can block competition for years. Here's how it works-and why it needs fixing.
How Brand Manufacturers Produce Their Own Generic Versions
Brand manufacturers produce their own generic versions to maintain market control when patents expire. These authorized generics are identical to the brand drug but sold under a different label, offering familiarity without the premium price.