Drug major Wockhardt has challenged the US patent of Stalevo, a new generation combination drug for the treatment of Parkinson's disease, originated by Finland-based Orion Corporation and marketed by Novartis.
Wockhardt has filed an abbreviated new drug-marketing application(ANDA) with the US Food and Drug Administration (FDA), seeking authorization to produce and market a generic version of Stalevo in 12.5, 200 and 50 mg strengths, said Orion Corporation. Approximately 6.5 million people worldwide suffer from Parkinson's disease, a disabling neurological condition. Stalevo simplifies the treatment process by combining levodopa, the most widely-used agent for treating Parkinson's disease, with enzyme inhibitors carbidopa and entacapone.
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