Wockhardt Ltd and its US based subsidiary - Wockhardt USA LLC, have executed a settlement and license agreement with Orion Corporation regarding Wockhardt's submission of ANDA for the generic versions of Orion's Comtan and Stalevo products.
Orion filed the first lawsuit in the US in 2007 and thereafter two additional lawsuits were filed in 2008. The settlement agreement relates to all three suits. Under the terms of the settlement agreement, Wockhardt will be able to launch generic versions of Comtan and Stalevo on September 30, 2012, or possibly even earlier, subject to certain conditions.
Wockhardt, as the first generic challenger to the Comtan patents, is eligible for 180 days of marketing exclusivity upon launch. Wockhardt also is the first-to-file on four strengths of Stalevo and is hence eligible to have 180 days of marketing exclusivity on these strengths upon launch. Additional terms related to the settlement remain confidential, and the agreement is subject to review by the US Department of Justice and the Federal Trade Commission.
Commenting on the settlement, Wockhardt chairman Habil Khorakiwala said, "We are pleased with the agreement and are excited to have capitalised on these first-to-file opportunities, which are an indication of the strength of our R&D and intellectual property initiatives. With over sixty products in the US market and a growing ANDA pipeline of technologically challenging products, we will look to continue our success in the United States market."
Comtan is used in the treatment of Parkinson's disease as an adjunct to levodopa/carbidopa therapy. Stalevo is a combination of carbidopa, levodopa and entacapone for the treatment of Parkinson's disease. Both products contain entacapone, a COMT enzyme-inhibiting agent. As per IMS Dec 2008, the annual sales of Comtan and Stalevo products in the US were $87 million and $113 million respectively.
The company received approval for 23 ANDAs from US FDA in 2008.