Print（PDF/139KB） Feb. 24, 2018 Corporate

SUMITOMO DAINIPPON PHARMA CO., LTD. Filed Additional Patent Infringement Lawsuit Regarding LATUDA in the United States

Sumitomo Dainippon Pharma Co., Ltd. ("Sumitomo Dainippon Pharma" or "we") filed a patent infringement lawsuit jointly with its U.S. subsidiary, Sunovion Pharmaceuticals Inc. ("Sunovion") on February 23, 2018 (U.S. Eastern Time) in the U.S. District Court for the District of New Jersey against fifteen companies^* and related companies regarding their submissions of Abbreviated New Drug Applications for generic copies of LATUDA^® (lurasidone HCl tablets). The lawsuit alleges infringement of Sumitomo Dainippon Pharma's U.S. Patent No. 9,815,827 ("the '827 Patent"). The lawsuit is similar to the lawsuits announced in Sumitomo Dainippon Pharma's press release issued on February 14, 2018.

Sumitomo Dainippon Pharma has granted Sunovion an exclusive license in the United States under the '827 Patent, and Sunovion has been marketing lurasidone HCl tablets in the United States under the brand name LATUDA^® since its launch in February 2011.

Sumitomo Dainippon Pharma and Sunovion continue to believe that our patent portfolio for LATUDA^® is very strong, and we will continue to vigorously protect our patent rights for LATUDA^®.

The lawsuit will not materially affect Sumitomo Dainippon Pharma's consolidated financial results of the fiscal year ending March 31, 2018. As to the financial impacts for the fiscal year ending March 31, 2019 and thereafter, we will make announcement as they become available.

* Fifteen companies are as follows:

・	Accord Healthcare Inc.	・	MSN Laboratories Private Ltd.
・	Amneal Pharmaceuticals, LLC	・	Par Pharmaceutical, Inc.
・	Aurobindo Pharma Ltd.	・	SUN PHARMA GLOBAL FZE
・	Dr. Reddy's Laboratories, Ltd.	・	Teva Pharmaceuticals USA, Inc.
・	First Time U.S. Generics, LLC.	・	Torrent Pharmaceuticals Ltd.
・	InvaGen Pharmaceuticals, Inc.	・	Watson Laboratories Inc.
・	Jubilant Generics Ltd.	・	Zydus Pharmaceuticals (USA) Inc.
・	Lupin Ltd.