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Wockhardt said on Tuesday that it has launched a generic version of Orion Corporation’s Parkinson’s treatment drug Stalevo in the US, with 180 days of marketing exclusivity.
The company said its generic copy is of four strengths (50mg, 75mg, 125mg and 200mg) of the triple drug combination product containing levodopa, carbidopa and entacapone.
“Wockhardt was the first—to—file with paragraph IV certification on four out of six strengths of this product,” Wockhardt Chairman, Mr Habil Khorakiwala, said in a statement.
Pursuant to a settlement of the litigation between Wockhardt and Orion Corporation, Finland, the two parties came to an arrangement to launch an authorised generic version with 180 days of exclusivity, he added.
“Wockhardt launched the product on April 23, 2012 and is entitled to 180 days of exclusivity,” the company said.
The combination of levodopa, carbidopa and entacapone tablet is the generic name for the brand Stalevo, owned by Orion Corporation and marketed in the US by Novartis.
Citing IMS Health, Wockhardt said 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.
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