Intas Pharmaceuticals and its wholly owned subsidiary Accord Healthcare have settled patent-related litigation between them and Hoffmann-La Roche on Capecitabine, sold under the brandname Xeloda.
The product is an orally administered chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers.
Intas has entered into a settlement and licence agreement with Roche, on different strengths of the product, Intas said. Xeloda tablets are projected to gross sales of about $706.2 million for the 12 months ended December 31, 2012, the Intas note said, citing IMS Health data.
Hoffmann-La Roche had filed a patent infringement suit against Accord Healthcare and Intas Pharmaceuticals, following Accord’s submission to the US Food and Drug Administration of an Abbreviated New Drug Application on the generic version of Xeloda. Approval of the generic version would allow Intas to sell a less expensive version of the Roche drug in the US.
As part of the agreement, Hoffman has granted Accord a license to enter the US market with a generic version of Xeloda tablets ahead of its exclusivity period. Following this agreement, pending litigation would be dismissed, Intas said. However, an Intas official did not comment on when the company would launch the drug in the US. Roche’s patent is expected to expire in December, he said, adding that the exclusivity period could extend to June 2014, if a paediatric version is approved by the US regulator.
The settlement comes at a time when agreements between innovator companies and generic drug-makers are under the scanner of US regulatory authorities. The concern is whether such agreements delay the launch of less expensive generic drugs for the local population.