PITTSBURGH Mylan has entered into an agreement with UCB to settle pending litigation involving UCB’s anti-epileptic seizure drug Keppra.
The two sides had been pending litigation since 2004 on a patent for the drug, which is set to expire on July 14, 2008. Now, Mylan receives the rights to market the 250, 500, and 750 mg strengths in the U.S. on Nov. 1, 2008.
This applies only if UCB obtains pediatric exclusivity for the drug and if Mylan can get its application approved by the Food and Drug Administration. If granted, the patent would extend until Jan. 14, 2009. But, if UCB fails to get the exclusivity Mylan could launch the generic sooner than Nov. 1.
Keppra had sales of about $742 million for the 12 months ending June 30, 2007 for the three strengths.