Wockhardt has launched an authorized generic version of four strengths (50 mg, 75 mg, 125 mg and 200mg) of the triple-drug combination product containing levodopa, carbidopa and entacapone, which are used in treatment of Parkinson's disease.

The levodaopa, carbidopa and entacapone tablet is the generic name for the brand Stalevo, owned by Orion Corporation and marketed in the US by Novartis. Wockhardt launched the product on April 23 and is entitled to 180-days of exclusivity.

Dr Habil Khorakiwala, chairman, said, “Wockhardt was the first-to-file with paragraph-IV certification on four out of six strengths of this product. Pursuant to a settlement of the litigation between Wockhardt and Orion Corporation, Finland, the holder of the NDA, Wockhardt came to an arrangement to launch an authorized generic version with 180-days of exclusivity. The product involved development of a complex API as well as a triple-drug combination formulation.”

Incidence of Parkinson's disease is increasing worldwide. According to IMS Health, the total market for this product in the US is about $55 million for the above four strengths and even after the 180-days exclusivity the number of competitors to enter the market is expected to be very limited.

In the US generic pharmaceutical market, Wockhardt has been consistently growing market shares for all its products. In many instances, Wockhardt, by virtue of being amongst the few players to market technically challenging products has reaped the advantage of being and early entrant.

Wockhardt is one of the select companies with end-to-end integrated capabilities for its products, starting with manufacture of the oral and sterile API's, the dose forms and marketing through the wholly owned subsidiary in the US enabling the company to capture maximum value.