Adenoscan patent lawsuits settled

Oct 22 2007

Astellas Pharma Inc., King Pharmaceuticals, Inc. and Teva Pharmaceutical Industries Ltd. have announced that U.S. 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 U.S. Patent No. 5,731,296, which expires in March 2015 and U.S. Patent No. 5,070,877, which expires in May 2009.

Adenoscan(R) (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 U.S. use patents with regard to adenosine injection owned by King and Item and has marketed Adenoscan in the U.S. since 1995.