Vanda settles Fanapt patent litigation with Taro

WASHINGTON —  Vanda Pharmaceuticals announced Tuesday that it had entered a license agreement with Taro to resolve its litigation against Taro’s for its abbreviated new drug application seeking approval for a generic of Vanda’s Fanapt (iloperidone). 

 

Under the agreement, Taro has a non-exclusive license to manufacture and commercialize its version of Fanapt in the U.S., effective Nov. 2, 2027, unless Vanda acquire pediatric exclusivity for Fanapt, in which case the license will be effective May 2, 2028. Under certain limited circumstances, Taro can enter the market earlier. 

 

The agreement is subject to review by the Federal Trade Commission and Dept. of Justice.