Tag: Hatch-Waxman Act

Generic drug patents and exclusivity periods vary widely across countries, affecting when affordable versions of medicines become available. The U.S., EU, and other regions use different rules to balance innovation and access.

The Hatch-Waxman Act revolutionized U.S. drug access by creating a fast, affordable path for generic drugs. It saved $1.7 trillion and now powers over 90% of prescriptions.

The 180-day exclusivity rule under the Hatch-Waxman Act rewards generic drugmakers for challenging patents-but it can delay market entry for years. Learn how it works, who benefits, and why reform is needed.