Tag: FDA exclusivity

Patent Exclusivity vs Market Exclusivity: What's the Real Difference for Drug Companies? 7 Feb 2026
Patent Exclusivity vs Market Exclusivity: What's the Real Difference for Drug Companies?

Patent exclusivity and market exclusivity are two separate legal tools that block generic drugs from entering the market. One comes from the patent office, the other from the FDA - and understanding the difference explains why some drugs stay expensive for years after patents expire.

180-Day Exclusivity in Generic Drug Market Entry: How Patent Law Shapes Drug Prices 7 Jan 2026
180-Day Exclusivity in Generic Drug Market Entry: How Patent Law Shapes Drug Prices

180-day exclusivity under the Hatch-Waxman Act gives the first generic drug challenger a temporary monopoly to incentivize patent challenges. But delays in market entry can block competition for years, keeping prices high for patients.