Category: Intellectual Property

Explore the legal basis and FDA approval process for generic drugs, from the Hatch-Waxman Act and ANDA pathways to bioequivalence and patent challenges.

Learn how the FDA uses the ANDA process and bioequivalence testing to approve safe, affordable generic drugs under the Hatch-Waxman Act.

85.7% of patent disputes settle before trial. Learn how companies use strategies like high-low structures and cross-licensing to resolve disputes efficiently and secure market entry.