Dr. Reddy’s Laboratories has announced that the company had filed an Abbreviated New Drug Application (ANDA) with the US 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