Vanda Pharmaceuticals (VNDA), Taro Pharma Enter Settlement over Generic Fanapt ANDA

October 24, 2016 4:06 PM EDT

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Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) announced it has entered into a License Agreement (the License Agreement) with Taro Pharmaceuticals U.S.A., Inc. and Taro Pharmaceutical Industries Ltd. (collectively, Taro) to resolve Vanda's patent litigation against Taro regarding Taro's Abbreviated New Drug Application seeking approval of its generic version of Vanda's Fanapt® (iloperidone).

Under the License Agreement, Vanda granted Taro a non-exclusive license to manufacture and commercialize Taro'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. Taro 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 and Taro of all claims that are the subject of the litigation.



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