Vanda Pharmaceuticals Inc. announced it has entered into a license agreement with Apotex Inc. and Apotex Corp. to resolve Vanda’s patent litigation against Apotex regarding Apotex’s Abbreviated New Drug Application seeking approval of its generic version of Vanda’s Fanapt (iloperidone).

Under the license agreement, Vanda granted Apotex a non-exclusive license to manufacture and commercialize Apotex’s version of Fanapt in the U.S. effective November 2, 2027, unless prior to that date Vanda obtains pediatric exclusivity for Fanapt, in which case, the license will be effective May 2, 2028.  Apotex 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. It provides for a full settlement and release by Vanda and Apotex of all claims that are the subject of the litigation.

Vanda is a specialty pharmaceutical company focused on the development and commercialization of novel therapies to address high unmet medical needs.  www.vandapharma.com.

(Source: PR Newswire)