Notice To Stock Exchange
Dr. Reddy's Announces ANDA Filing for Moxifloxacin tablets
Dr. Reddy's Laboratories (NYSE:RDY) today announced that the Company had filed an Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration for Moxifloxacin tablets 400 mg, with a Paragraph IV certification on all the Orange Book patents listed for the drug, on December 10, 2003 (the first day of eligibility for an ANDA filing with a Para IV certification).
Dr. Reddy's notified Bayer, upon which the latter filed a lawsuit against the Company in the United States District Court for the District of Delaware, alleging patent infringement on two of the three Orange Book patents.
Moxifloxacin is the generic version of Bayer's Avelox® and is indicated for the treatment of respiratory tract infections. The brand had annual sales in the United States of approximately $ 207 million (Source: IMS MAT September 2003).