Orion proprietary drug Stalevo used as treatment for Parkinson’s disease

Orion’s Stalevo, an enhanced levodopa treatment, is being used to treat Parkinson’s disease.

Currently marketed in the US by its exclusive licensee, Novartis Stavelo, has been listed in the Orange Book, the Food and Drug Administration’s (FDA’s) official listing of approved drug products, by Orion.

The Finnish company is now part of an abbreviated new drug application (ANDA) filed by Wockhardt with the US FDA, applying for authorisation to produce and market its own version of Stavelo.

Workhardt’s ANDA for Stalevo contains so-called Paragraph IV certifications challenging Orion’s US patents numbers 5,135,950, 5,446,194, 6,500,867 and 6,797,732.

Paragraph IV certifications are not uncommon in the US, according to Orion, with the company currently evaluating its legal options in an attempt to protect its rights.

The action follows Orion suing Wockhardt for patent infringement when it challenged certain US patents as part of an earlier filed ANDA on Comtan (entacapone), which is currently pending in the district court for the district of Delaware.

Orion’s net sales in 2007 were 683.6 million euros (541.59 pounds), with the company putting 98.5 million euros put into research and development.

Based in Espoo, Finland, the organisation currently employs approximately 3,300.