Tag: Hatch-Waxman Act
Regulatory Exclusivity Explained: Non-Patent Market Protections in Pharma
Regulatory exclusivity provides non-patent market protection for drugs, blocking generics for set periods after approval. Learn about NCE, orphan, and biologics exclusivity rules in the US and EU.
Federal Circuit Court: Authority on Pharmaceutical Patent Cases
The Federal Circuit Court holds exclusive authority over all U.S. pharmaceutical patent cases, shaping how generics enter the market through rulings on ANDA filings, Orange Book listings, and dosing patent validity. Its decisions impact drug prices, innovation, and patient access.