Mylan Inc. today confirmed that its majority-owned subsidiary, Matrix Laboratories Ltd., has been sued by Daiichi Sankyo in connection with Amlodipine Besylate/Olmesartan Medoxomil Tablets, 5 mg/20 mg, 10 mg/20 mg, 5 mg/40 mg and 10 mg/40 mg, the generic version of Daiichi Sankyo's Azor Tablets.
Mylan believes that Matrix is the first company to file a substantially complete Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for the product. Matrix filed an ANDA with the U.S. Food and Drug Administration (FDA) in early 2008.
Daiichi Sankyo filed a lawsuit yesterday in the U.S. District Court for the District of New Jersey alleging infringement of the sole patent relating to Azor, which is listed in the "Orange Book" as U.S. Patent No. 5,616,599.