Tag: Hatch-Waxman Act

Patent Exclusivity vs Market Exclusivity: Key Differences Explained

February 4, 2026 Alyssa Penford 14 Comments

Patent and market exclusivity are key protections for pharmaceuticals. Patents protect inventions from USPTO; market exclusivity is FDA-granted. They differ in duration, enforcement, and scope. Understanding both helps navigate drug development and generic competition. Real-world examples show their impact on drug pricing and availability.

Patent Term Restoration (PTE): How Drug Patents Get Extra Years of Exclusivity

January 26, 2026 Alyssa Penford 9 Comments

Patent Term Restoration lets drug companies extend patent life to make up for FDA approval delays. Learn how it works, who qualifies, and why it's changing drug prices.

Effective Patent Life: Why Market Exclusivity in Pharmaceuticals Is Shorter Than You Think

December 16, 2025 Alyssa Penford 13 Comments

Effective patent life in pharmaceuticals is often just 10-15 years, far less than the 20-year patent term due to lengthy development and approval processes. Learn how Hatch-Waxman, secondary patents, and exclusivities shape drug pricing and competition.

First-Mover Advantage: How First Generic Drug Manufacturers Dominate the Market

November 13, 2025 Alyssa Penford 11 Comments

The first generic drug manufacturer to launch after a patent expires gains a lasting market edge thanks to prescriber habits, pharmacy stocking rules, and patient loyalty-far beyond the 180-day exclusivity period.

Tag: Hatch-Waxman Act

Patent Exclusivity vs Market Exclusivity: Key Differences Explained

Patent Term Restoration (PTE): How Drug Patents Get Extra Years of Exclusivity

Effective Patent Life: Why Market Exclusivity in Pharmaceuticals Is Shorter Than You Think

First-Mover Advantage: How First Generic Drug Manufacturers Dominate the Market

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