The Delhi-based Fresenius Kabi Oncology Ltd (formerly Dabur Pharma Ltd), which specialises in anti-cancer therapy on Monday said it has resolved its patent row with French drug firm Sanofi-Aventis and has entered into a licence agreement with the latter for injectable drug Eloxatin (Oxaliplatin).
The agreement resolves a patent infringement suit filed by Sanofi-Aventis in June 2007 in the US, the company said in a statement. Eloxatin is used for the treatment of stage-III colon cancer. The drug clocked revenues worth $993 million in the US market in 2009.
Under the terms of agreement, Fresenius Kabi Oncology and its subsidiaries would have the licence to market the generic version of the cancer drug in different strengths from August 2012.
In 2007, Fresenius Kabi Oncology Ltd, through its wholly-owned subsidiary Fresenius Kabi Oncology Plc, UK had filed two abbreviated new drug applications (ANDAs) with the US Food and Drug Administration seeking approval to market the generic versions of Oxaliplatin injection and Oxaliplatin for the injection.
In response to these filings, Sanofi Aventis had filed lawsuits against Fresenius alleging that the proposed products would infringe certain patents of Sanofi Aventis valid till 2017.
Fresenius already markets the drug in unregulated markets, where the injectible is not patented. Last week, French drug maker Sanofi-Aventis had announced that it has settled three patent infringement lawsuits pending in the US courts related to the generic versions of its patented cancer drug Eloxatin involving several drug manufacturers including Fresenius.
Singapore-based Fresenius Kabi acquired Delhi-based cancer drug manufacturer Dabur Pharma in 2008 and later renamed it as Fresenius Kabi Oncology.