Vanda Pharmaceuticals Inc. (Vanda) announced it has entered into a License Agreement (the License Agreement) with MSN Pharmaceuticals Inc., MSN Laboratories Private Limited (together MSN) and Impax Laboratories LLC (Impax) to resolve Vanda’s patent litigation against MSN regarding MSN’s Abbreviated New Drug Application seeking approval of its generic version of Vanda’s HETLIOZ® (tasimelteon).
Under the License Agreement, Vanda granted MSN and Impax a non-exclusive license to manufacture and commercialize MSN’s version of HETLIOZ® in the U.S. effective March 13, 2035, unless prior to that date Vanda obtains pediatric exclusivity for HETLIOZ®, in which case, the license will be effective July 27, 2035. MSN and Impax may enter the market earlier under certain limited circumstances.
The License Agreement is subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice. The License Agreement provides for a full settlement and release by Vanda, MSN and Impax of all claims that are the subject of the litigation.
About Vanda Pharmaceuticals Inc.
Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., About HETLIOZ®
HETLIOZ® (tasimelteon) is a melatonin receptor agonist. HETLIOZ® has been granted market authorization by the U.S. Food and Drug Administration and the European Medicines Agency. For full U.S. Prescribing Information for HETLIOZ®, including indication and Important Safety Information,
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Various statements in this press release, including, but not limited to statements regarding the License Agreement, are “forward-looking statements” under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda’s forward-looking statements include,