Vanda Pharmaceuticals Inc. today responded to the ruling in its Hetlioz® Abbreviated New Drug Application appeal.
Today a three-judge panel of the United States Court of Appeals for the Federal Circuit issued a written opinion that affirmed a December 13, 2022, decision of the United States District Court for the District of Delaware, which held that the asserted claims of Vanda’s U.S. Patent Nos. RE46,604; 9,730,910; 10,149,829; and 10,376,487 are invalid.
This ruling will allow Teva Pharmaceuticals Industries Ltd. and Apotex Inc. to release generic versions of the treatment for Non-24-Hour Sleep-Wake Disorder (Non-24).
Hetlioz sales were nearly 65% of Vanda’s 2021 revenue. Vanda is considering its options, including whether to request a rehearing.
HETLIOZ® is also approved in the European Union and is not subject to this litigation, nor is generic litigation pending outside of the United States. The litigation does not relate to the HETLIOZ LQ® oral suspension formulation.
Source: Vanda Pharmaceuticals Inc.