BioCentury
ARTICLE | Company News

Orion, Mylan, Novartis neurology news

May 7, 2012 7:00 AM UTC

Orion filed a suit in the U.S. District Court for the District of Delaware claiming that an ANDA from Mylan for a generic version of Stalevo levodopa/carbidopa/entacapone infringes Orion's U.S. Patent Nos. 5,446,194; 6,500,867; and 6,797,732 which cover the Parkinson's disease drug. In March, Orion received notice that Mylan submitted the ANDA, which Orion said contains a Paragraph IV notification claiming that the three patents covering Stalevo are invalid and/or unenforceable. Mylan is seeking to market generic versions of the 12.5/50/200, 18.75/75/200, 25/100/200, 31.25/125/200, 37.5/150/200 and 50/200/200 mg strengths of Stalevo. Orion reiterated that "generic competition is not imminent based on this application." Novartis has worldwide rights to Stalevo outside of the U.K., Germany, Ireland and the Nordic Baltic regions, where Orion retains rights (see BioCentury, April 2).

In 2010, Orion granted Sun Pharmaceutical Industries Ltd. (BSE:524715; NSE:SUNPHARMA, Mumbai, India) and Wockhardt Ltd. (BSE:532300, Mumbai, India) rights to market generic versions of Stalevo to settle separate patent infringement suits between Orion and the other companies. Sun's rights to market the 25/100/200 and 37.5/150/200 mg strengths of Stalevo in the U.S. began on April 1, 2012, while its rights to market other strengths begin on Oct. 2, 2012. Wockhardt's rights to market generic versions of Stalevo, excluding the 25/100/200 and 37.5/150/200 mg strengths, in the U.S. began on April 1, 2012 (see BioCentury, Aug. 30, 2010). ...