UCB settles US Keppra patent suit

Belgian biopharmaceutical firm UCB says it has settled a pending patent infringement law suit relating to levetiracetam, the active ingredient in its anti-epileptic drug Keppra. Parties involved in the deal include the USA's Mylan, Indian generics major Dr Reddy's Laboratories and Canada's Cobalt Pharmaceuticals, all of which had sought to sell non-branded versions of the drug in the USA.

Under the terms of the settlement, which is still subject to US Food and Drug Administration approval, Mylan will be allowed to sell its generic version of Keppra, in 250mg, 500mg and 750mg dosage strengths in the USA from November 1 next year, provided that UCB is granted pediatric exclusivity, a decision which, if granted, would extend the Belgian firm's patent protection to January 14, 2009. UCB said that further terms of its settlement with Mylan, Dr Reddy's and Cobalt are to remain confidential by mutual agreement.

UCB said that the FDA is expected to issue its decision on pediatric exclusivity for Keppra sometime during next year.