Astellas Pharma Inc. (Astellas), King Pharmaceuticals, Inc. (King) and Teva Pharmaceutical Industries Ltd. (Teva) announced that US subsidiaries of Astellas, along with Item Development AB and King have executed settlement agreements with one of Teva's subsidiaries on lawsuits filed in the United States against Teva's subsidiaries regarding their submission of an abbreviated new drug application (ANDA) for a generic version of Adenoscan (adenosine injection), a pharmacologic stress agent.
Two lawsuits were filed by Astellas US LLC and Astellas Pharma US, Inc. in the US District Court in Delaware on May 26, 2005 one with co-plaintiff Item and the other with co-plaintiff King, respectively.
Under the terms of the settlement agreement, Teva will be able to launch their generic version of Adenoscan pursuant to a license in September 2012, or earlier under certain conditions. Except as described, the terms of the settlement are confidential.
Subject to the Court's approval, the cases will be dismissed and the patents remain in place including US Patent No. 5,731,296, which expires in March 2015 and US Patent No. 5,070,877, which expires in May 2009.
Adenoscan (adenosine injection), licensed and sold by Astellas in the US, is a pharmacologic stress agent indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.
Astellas is the exclusive licensee of the US use patents with regard to adenosine injection owned by King and Item and has marketed Adenoscan in the US since 1995.
Astellas Pharma US, Inc., located in Deerfield, Illinois, is a US affiliate of Tokyo-based Astellas Pharma Inc., Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.
King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products in attractive markets and the strategic acquisition of branded products that can benefit from focused promotion and marketing and life-cycle management.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products.