Tag: FDA exclusivity

Biologic Patent Protection: When Biosimilars Can Enter the U.S. Market

Biologic Patent Protection: When Biosimilars Can Enter the U.S. Market

Biologic patent protection in the U.S. delays biosimilar entry for up to 12 years, keeping drug prices high. Learn how the BPCIA, patent thickets, and development costs block competition - and what it means for patients.

Patent Exclusivity vs Market Exclusivity: What’s the Real Difference in Drug Protection?

Patent Exclusivity vs Market Exclusivity: What’s the Real Difference in Drug Protection?

Patent exclusivity and market exclusivity are two separate legal tools that protect new drugs. Patents cover inventions; market exclusivity blocks generic approval. Understanding both explains why drug prices stay high even after patents expire.