US generics major Mylan says that its majority-owned subsidiary, Matrix Laboratories, is being sued by Japan's Daiichi Sankyo in connection with amlodipine besylate/olmesartan medoxomil tablets, 5mg/20mg, 10mg/20mg, 5mg/40mg and 10mg/40mg, the generic version of the latter's Azor tablets.
Mylan believes that Matrix is the first company to file a substantially complete Abbreviated New Drug Application containing a Paragraph IV certification for the product. Matrix filed with the Food and Drug Administration in early 2008.
Daiichi Sankyo filed a law suit on June 3 in the US 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 US Patent No 5,616,599.
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