Tag: Paragraph IV certification

180-Day Exclusivity and Authorized Generics: Legal Considerations in U.S. Drug Markets
Medicine

180-Day Exclusivity and Authorized Generics: Legal Considerations in U.S. Drug Markets

The 180-day exclusivity rule was meant to reward generic drugmakers for challenging patents, but authorized generics let brand-name companies undercut them. This legal loophole is reshaping competition in the U.S. drug market.

READ MORE