Sumitomo Dainippon Pharma Co. Ltd. and its U.S. subsidiary, Sunovion Pharmaceuticals Inc. of Marlborough filed patent infringement lawsuits Wednesday related to its antipsychotic drug Lutuda.
The lawsuits were filed in U.S. District Court in New Jersey against Emcure Pharmaceuticals Limited, Emcure Pharmaceuticals USA Inc., and InvaGen Pharmaceuticals Inc. regarding their applications for generic copies of Latuda (lurasidone HCl) tablets.
The lawsuits allege infringement of a Sumitomo Dainippon patent that expires July 2, 2018.
A statement from the drug makers says the 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.”
The lawsuits will likely delay FDA approval of the applications until at least 2018, the statement said.
