A Costly 180: The D.C. Circuit Flips FDA’s Forfeiture Playbook August 27, 2026 By Peter G. Dickos & Sara W. Koblitz & Kurt R. Karst —

https://www.thefdalawblog.com/2026/08/a-costly-180-the-d-c-circuit-flips-fdas-forfeiture-playbook/?utm_source=rss&utm_medium=rss&utm_campaign=a-costly-180-the-d-c-circuit-flips-fdas-forfeiture-playbook What a year for Hatch-Waxman litigation! With the Supreme Court’s decision in Amarin v. Hikma, it’s already been a big year for the Hatch-Waxman Amendments, but now we have another case from the D.C. Circuit that touches on an important aspect of generic drug incentives: 180-day exclusivity. More specifically, 180-day exclusivity forfeiture, a topic so complicated that FDA’s Guidance on 180-Day Exclusivity spends 12 of its 26 pages of Frequently Asked Questions explaining it.