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Otsuka Prevails in U.S. Abilify Patent Litigation

Tuesday, November 16, 2010

Tokyo -- Otsuka Pharmaceutical Co., Ltd. and Otsuka Holdings, Co., Ltd., the parent company of Otsuka Pharmaceutical Co., Ltd., announced today that the U.S. District Court for the District of New Jersey issued its judgment dated November 15, 2010 in favor of Otsuka Pharmaceutical Co., Ltd. in its patent litigation against several companies seeking FDA approval to market generic copies of Abilify®.

The District Court held that the asserted claims of U.S. Patent No. 5,006,528 covering aripiprazole, the active ingredient in Abilify®, are both valid and enforceable, thus maintaining patent and regulatory protection for Abilify® in the United States until at least April 20, 2015.

The District Court also held that the proposed generic products infringe these patent claims, and accordingly precluded the FDA from approving, and enjoined the respective companies from marketing, these products in the United States until at least April 20, 2015.

About Otsuka

Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: 'Otsuka-people creating new products for better health worldwide.' Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and consumer products for the maintenance of everyday health. Otsuka is committed to being a corporation that creates global value, adhering to the high ethical standards required of a company involved in human health and life, maintaining a dynamic corporate culture, and working in harmony with local communities and the natural environment.

Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group. The Otsuka Group comprises 145 companies and employs approximately 39,000 people in 23 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned ¥1,084.2 billion (approx. US $11.7 billion) in annual revenues in fiscal 2009. Visit Otsuka Pharmaceutical Co., Ltd. at

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