Dr Reddy’s Laboratories has announced that the company had filed an Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration (FDA) for Levetiracetam tablets of 250, 500 and 750 mg, with a Paragraph IV certification on the two Orange Book patents listed for the drug.
Dr Reddy’s notified UCB, upon which the latter filed a lawsuit against the company in the United States District Court for the District of Georgia, alleging patent infringement on the two Orange Book patents.
Dr. Reddy’s believes that it has the first-to-file status along with one other filer, on all dosage strengths and if successful in its litigation, would enjoy a 180-day marketing co-exclusivity pursuant to the July 2003 FDA guidance on 180-day exclusivity when multiple ANDAs are filed on the same day.
Levetiracetam is the generic version of UCB’s Keppra and is indicated for the treatment of epilepsy. The brand had annual sales in the United States of approximately $ 234 million (Source: IMS MAT September 2003).