Wockhardt settles patent row with Orion Corporation
29 April 2009
Wockhardt USA LLC, a subsidiary of pharmaceutical and biotechnology major Wockhardt Limited, has signed a settlement and license agreement with Orion Corporation of the US regarding Wockhardt's abbreviated new drug applications (ANDAs) for the generic versions of Orion's Comtan and Stalevo products, the company said in a release.
Comtan is used in the treatment of Parkinson's disease as an adjunct to levodopa/carbidopa therapy while Stalevo is a combination of carbidopa, levodopa and entacapone used for the treatment of Parkinson's disease.
Both products contain entacapone, a COMT enzyme-inhibiting agent. As per IMS December 2008, the annual sales of Comtan and Stalevo products in the US were $87 million and $113 million, respectively.
''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,'' said Wockhardt chairman Habil Khorakiwala.
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 30 September 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,'' the release said, adding, ''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.''
With 23 ANDA approvals by the US FDA in 2008, Wockhardt was amongst the top 5 companies in the world, in terms of the highest number of generic approvals.
Wockhardt has 5 research centres and 15 world-class manufacturing plants in various countries and continents that are compliant to international regulatory standards such as the US FDA and MHRA. It has end-to-end integrated capabilities for products, starting with manufacture of the oral and sterile APIs. Wockhardt has a global footprint, including the US, UK, Ireland, France and Germany with a multi-ethnic workforce from 14 different nationalities.