Benzinga | Jan 14, 2022 08:35AM EST

Vanda Pharmaceuticals Settles HETLIOZ Patent Litigation With MSN

Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today 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(r) (tasimelteon).

Under the License Agreement, Vanda granted MSN and Impax a non-exclusive license to manufacture and commercialize MSN's version of HETLIOZ(r) in the U.S. effective March 13, 2035, unless prior to that date Vanda obtains pediatric exclusivity for HETLIOZ(r), 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.