Sumitomo Dainippon Pharma Co., Ltd. and its U.S. subsidiary, Sunovion Pharmaceuticals Inc., jointly filed patent infringement lawsuits on January 14, 2015 in the U.S. District Court for the District of New Jersey against Emcure Pharmaceuticals Limited, Emcure Pharmaceuticals USA, Inc., and InvaGen Pharmaceuticals Inc. regarding their submissions of Abbreviated New Drug Applications for generic copies of Latuda ® (lurasidone HCl) tablets. The lawsuits allege infringement of Sumitomo Dainippon Pharma’s U.S. Patent No. 5,532,372 (“the ’372 Patent”).
The ’372 Patent is exclusively licensed to Sunovion in the United States, and Sunovion has been marketing lurasidone HCl tablets in the United States under the brand name LATUDA ® since its launch in February 2011.
Due to the commencement of these lawsuits, the FDA approval of the ANDAs will be stayed at least until the earlier of April 28, 2018 (plus an additional six months thereafter if Sunovion is awarded a pediatric exclusivity extension) or the date of a district court decision finding the ’372 Patent invalid, unenforceable, or not infringed. Should Sumitomo Dainippon Pharma and Sunovion successfully enforce the ’372 Patent, ANDA approval should not occur at least until expiration of that patent on July 2, 2018 (plus an additional six months thereafter if Sunovion is awarded a pediatric exclusivity extension).
Sumitomo Dainippon Pharma and Sunovion believe that their patent position for LATUDA ® is strong and they are prepared to vigorously protect their patent rights.