Orion files suit blocking Wockhardt's generic Stalevo

Finnish drugmaker Orion Corp has filed a patent infringement law suit to enforce three US patents against the US unit of Indian drugmaker  Wockhardt, that is seeking to market generic versions of Orion's  proprietary Parkinson's drug, Stalevo (25/200/100mg, 37.5/200/150mg, and  50/200/200mg strengths of carbidopa/entacapone/levodopa) in the USA.

Stalevo is an enhanced levodopa treatment originated by Orion and  marketed in the USA by its exclusive licensee, Swiss drug major  Novartis.

Wockhardt submitted an Abbreviated New Drug Application with the US Food  and Drug Administration (FDA) that included a Paragraph IV challenge to  several of Orion's patents. By suing to enforce its patents within 45  days from receipt of the Paragraph IV certification notice, Orion is  entitled to an automatic stay prohibiting the approval of the ANDA for  30 months, or earlier if a court rules against the branded drugmaker  before then.