New Delhi: Sun Pharmaceutical Industries on Tuesday said it has settled patent litigation with Finland-based Orion over generic versions of Stalevo and Comtan tablets, which are used for the treatment of Parkinson’s disease.
Besides, the firm also said it has got approval from the US Food and Drugs Administration to sell generic version of Optivar, indicated for itching of the eyes, in the US market.
In a statement, Sun Pharma said it has executed a settlement agreement with Orion that would enable it to launch the generic versions of Stalevo and Comtan in multiple strengths in the US, as early as 1 April 2012.
“Under the settlement agreement, Sun Pharma will be able to launch generic versions of Stalevo tablets in strengths of 25/100/200 mg and 37.5/150/200 mg in the US on April 1, 2012,” the company said.
In addition to these strengths, Sun Pharma will be able to launch generic versions of other strengths of Stalevo products on 2 October 2012 and generic versions of Comtan product on 1 April 2013, unless certain conditions relating to the launch are fulfilled even earlier, it added.
“The parties have agreed that Orion will supply generic product versions to Sun Pharma. Other terms of the settlement have been kept confidential,” the statement said.
In November 2007, Orion had filed patent litigation against Sun Pharma over Stalevo when the Indian firm had applied for abbreviated new drug application (ANDA) to the US Food and Drugs Administration (USFDA). Orion had given exclusive marketing rights for Stalevo in the US to Novartis.
In another statement, Sun Pharma said it has received USFDA nod for selling generic version of Medpointe Pharmaceuticals’ Optivar, indicated for itching of the eyes, in the US market.
Optivar and its generic versions have estimated annual sales of $50 million in the US.
Shares of Sun Pharma were trading at Rs1,761.15 on late afternoon trade on the BSE, up 0.42% from its previous close.