BioCentury
ARTICLE | Company News

Orion, Mylan, Novartis neurology news

January 31, 2011 8:00 AM UTC

Orion filed suit in the U.S. District Court for the District of Delaware alleging that Mylan infringed U.S. Patent No. 5,446,194 covering Parkinson's drug (PD) Comtan entacapone. Mylan submitted an ANDA to FDA for a generic version of entacapone last year. The ANDA contains a Paragraph IV notification that the '194 patent is invalid, unenforceable and/or will not be infringed by the approval or sale of Mylan's generic. Orion is seeking to prevent the approval and sale of Mylan's generic before the '194 patent expires on Oct. 19, 2013. ...