VANDA PHARMACEUTICALS INC. (NASDAQ:VNDA) Files An 8-K Other EventsItem 8.01. Other Events.
On March23, 2018 (the “Notice Date”), Vanda Pharmaceuticals Inc. (“Vanda”) received a Paragraph IV certification notice letter (the “Notice Letter”) regarding an Abbreviated New Drug Application (“ANDA”) submitted to the U.S. Food and Drug Administration (the “FDA”) by Teva Pharmaceuticals USA, Inc. (“Teva”) requesting approval to market, sell and use a generic version of the 20mg HETLIOZ® (tasimelton) capsule product for Non-24-Hour Sleep-Wake Disorder.
In its Notice Letter, Teva alleges that U.S. Patent Nos. 9,060,995; 9,539,234; 9,549,913; 9,730,910; 9,855,241 and RE46,604 (collectively, the “Patents”), which cover methods of using HETLIOZ®, are invalid, unenforceable and/or will not be infringed by Teva’s manufacture, use or sale of the product described in its ANDA. The latest of the Patents expires in 2034.
Vanda is currently reviewing the Notice Letter and intends to vigorously enforce its intellectual property rights relating to HETLIOZ®. By statute, Vanda has 45 days from receipt of the Notice Letter to initiate a patent infringement lawsuit against Teva. Such a lawsuit would automatically preclude the FDA from approving Teva’s ANDA until the earlier of 30 months from the Notice Date or entry of a district court decision finding the patents invalid, unenforceable or not infringed. The composition and use of HETLIOZ® are currently protected by seven issued patents that are listed in the FDA’s Orange Book.
About VANDA PHARMACEUTICALS INC. (NASDAQ:VNDA)
Vanda Pharmaceuticals Inc. is a biopharmaceutical company. The Company is focused on the development and commercialization of pharmaceutical products for the treatment of central nervous system (CNS) disorders. The Company’s product portfolio includes HETLIOZ (tasimelteon), Fanapt (iloperidone), Tradipitant (VLY-686), Trichostatin A and AQW051. The Company offers HETLIOZ (tasimelteon) for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24). The Company offers Fanapt (iloperidone) for the treatment of schizophrenia. Additionally, its distribution partners launched Fanapt in Israel and Mexico. Tradipitant (VLY-686) is a small molecule neurokinin-1 receptor (NK-1R) antagonist, which is in clinical development for the treatment of chronic pruritus in atopic dermatitis. Trichostatin A is a small molecule histone deacetylase (HDAC) inhibitor. AQW051 is a Phase II alpha-7 nicotinic acetylcholine receptor partial agonist. It is indicated for the treatment of CNS Disorders.