Vanda Pharmaceuticals said it granted Apotex Inc. and Apotex Corp. a nonexclusive license to manufacture and sell a version of Fanapt in the U.S., effective Nov. 2, 2027.
The license agreement resolves Vanda's patent litigation against Apotex regarding the latter's abbreviated new drug application for its generic version of Vanda's Fanapt.
If Vanda obtains pediatric exclusivity for Fanapt before Nov. 2, 2027, the license, which is subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice, will be effective May 2, 2028.
Fanapt is used in the treatment of schizophrenia in adults.