Actavis And Kissei File Lawsuits Against Sandoz And Hetero For Infringement Of Rapaflo® Patent
PARSIPPANY, N.J., June 19, 2013 -- Actavis, Inc. (NYSE: ACT) and Kissei Pharmaceutical Co., LTD today confirmed that they have filed lawsuits against Sandoz Inc., Hetero USA, Inc., Hetero Labs Limited and Hetero Labs Limited, Unit III in the U.S. District Court for the District of Delaware for infringement of U.S. Patent No. 5,387,603 (the '603 patent) covering Rapaflo®, a treatment for the signs and symptoms of benign prostatic hyperplasia (BPH).
Actavis and Kissei's lawsuits were filed in response to Abbreviated New Drug Applications (ANDA) filed by each of Sandoz and Hetero seeking U.S. Food and Drug Administration (FDA) approval to market a generic version of Actavis' Rapaflo® (Silodosin 4-mg and 8-mg capsules) prior to the expiration of the '603 patent. The lawsuits were filed under the provisions of the Hatch-Waxman Act, accordingly, the FDA must refrain from approving the Sandoz and Hetero ANDAs prior to April 8, 2016, or until a district court decision finding that the '603 patent is invalid or not infringed, whichever occurs earlier.
Actavis, Inc. (NYSE: ACT) is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. Actavis has global headquarters in Parsippany, New Jersey, USA.
Operating as Actavis Pharma, Actavis develops, manufactures and markets generic, branded generic, legacy brands and Over-the-Counter (OTC) products in more than 60 countries. Actavis Specialty Brands is Actavis' global branded specialty pharmaceutical business focused in the Urology and Women's Health therapeutic categories. Actavis Specialty Brands also has a portfolio of five biosimilar products in development in Women's Health and Oncology. Actavis Global Operations has more than 30 manufacturing and distribution facilities around the world, and includes Anda, Inc., a U.S. pharmaceutical product distributor.
For press release and other company information, visit Actavis' Web site at http://www.actavis.com.
Kissei Pharmaceutical Co., Ltd. was founded in 1946 and has grown into one of Japan's leading pharmaceutical companies. Kissei's management vision is to be an R&D-oriented pharmaceutical company that contributes to the health of people around the world through developing and commercializing innovative drugs. Kissei is actively pursuing collaborations with many companies to strengthen its R&D pipeline, and also promoting global expansion by licensing out original agents as an important management strategy.
For more information on Kissei, please see the international website. http://www.kissei.co.jp/
Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Actavis' current perspective of existing information as of the date of this release. It is important to note that Actavis' goals and expectations are not predictions of actual performance. Actual results may differ materially from Actavis' current expectations depending upon a number of factors, risks and uncertainties affecting Actavis' business. These factors include, among others; the difficulty of predicting the timing and outcome of the pending patent litigation; the difficulty of predicting the timing or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any; the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to Actavis and its third party manufacturers' facilities, products and/or businesses; changes in the laws and regulations; and such other risks and uncertainties detailed in Actavis' periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis' Quarterly Report on Form 10-Q for the quarter ended March 31, 2013 and Actavis' Annual Report on form 10-K for the year ended December 31, 2012. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.