Cephalaon sues DRL over leukemia drug
Mar 18 2014 , Hyderabad
Cephalon’s drug treats chronic lymphocytic leukemia and non-Hodgkin’s lymphoma. The company has been selling the drug in 2008.
The infringement is for patent 8,609,863 (863 patent) and 8,436,190 (190 patent) as well as Patent No. 8,445,524 (the’524 patent). Dr. Reddy’s had filed for an Abbreviated New Drug Application with the United States food and drug administration (USFDA) to be able to make and market the generic versions of this drug.
The 863 patent, entitled “Bendamustine Pharmaceutical Compositions,” was issued on December 17, 2013 to inventors Jason Edward Brittain and Joe CraigFranklin. The ’863 patent is listed in FDA publication as “Approved Drug Products with Therapeutic Equivalence Evaluations,” also known as the Orange Book. The patent will expire on January 12, 2026.
“DRL filed with FDA an ANDA seeking, approval to manufacture, use, offer for sale, sell in and import into the United States IV powder for infusion, containing 25 mg of bendamustine HCl and 100 mg bendamustineHCl (“DRL’s Bendamustine Product”) prior to the expiration of US Patent No. 8,445,524 (“the’524 patent”), US Patent No. 8,436,190 (“the ’190 patent”) and the ’863 patent,” the company said in its plea.