Dr Reddy's Laboratories has filed an Abbreviated New Drug Application with the United States Food and Drug Administration for Levetiracetam tablets, 250, 500 and 750 mg.
When DRL notified US company UCB about the tablets, the latter filed a lawsuit against DRL in the US District Court of Georgia alleging patent infringement on the two Orange Book patents, DRL said in a release on Monday.
The DRL believes that it has the first-to-file status along with one other filer, on all dosage strengths, the release said adding, if successful in its litigation, it would enjoy a 180-day marketing co-exclusivity pursuant to the July 2003 FDA guidance on 180-day exclusivity when multiple ANDAs were filed on the same day.
Levetiracetam is the generic version of UCB's Keppra and is used for the treatment of epilepsy.
