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Vanda Pharmaceuticals intends to appeal Hetlioz ANDA litigation decision

Vanda Pharmaceuticals (VNDA) responded to the ruling in its Hetlioz ANDA litigation with the following statement: "Vanda has brought several Hatch-Waxman lawsuits in the United States District Court for the District of Delaware against Teva Pharmaceuticals USA, Inc. and Apotex Inc. asserting infringement of patents covering Hetlioz 20 mg capsules. A trial was held in March 2022. Today the Court ruled that Teva and Apotex did not infringe U.S. Patent No. RE46,604, and that the asserted claims of U.S. Patent Nos. RE46,604; 9,730,910; 10,149,829; and 10,376,487 are invalid. Vanda intends to appeal the decision to the United States Court of Appeals for the Federal Circuit and to request a stay of market entry by Teva and Apotex while the appeal is pending. 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."

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