Orion sues Sun Pharmaceuticals over Stalevo patent

Orion has announced that it has filed a patent infringement lawsuit against Sun Pharmaceutical Industries, a firm seeking to market generic versions of Stalevo (carbidopa/levodopa/entacapone) tablets at 25/100/200 mg and 37.5/150/200 mg strengths.

Stalevo is an enhanced levodopa treatment covered in the US by patent No 5,446,194, known as the ‘194 patent.

It was originated by Orion and is currently marketed in the US by Novartis for the treatment of Parkinson’s disease.

Orion was previously notified that Sun had amended its abbreviated new drug application with the US Food and Drug Administration which included a paragraph IV challenge of Orion’s ‘194 patent.

“Orion Corporation has now sued Sun for infringement of two Orion Corporation patents in response to Sun’s Paragraph IV challenges,” the company reports.

“The other patent is US Patent No. 6,500,867. Due to recent developments, Orion Corporation has removed Sun Pharmaceutical Industries Inc. from the prior lawsuit.”

It adds that it has maintained the prior action against the firm, its parent company and abbreviated new drug application holder.

Last month, Orion reported positive results of a phase III clinical trial testing the effects of Stalevo in patients with early-stage Parksinson’s disease.