Tag: Hatch-Waxman Act

Effective Patent Life: Why Market Exclusivity Is Shorter Than 20 Years

Discover why effective patent life is shorter than the standard 20-year term. Learn about the Hatch-Waxman Act, regulatory exclusivities, and how pharmaceutical companies use secondary patents to extend market dominance.

Tentative Approval and Litigation: How Generic Drug Makers Wait for Market Entry

Tentative approval from the FDA lets generic drug makers prepare for market entry while waiting for patents to expire. Learn how patent litigation, timing, and paperwork determine who wins the race to sell generics.