AHMEDABAD, India, June 25, 2013 /PRNewswire/
Intas Pharmaceuticals Ltd. and its wholly owned subsidiary Accord Healthcare Inc., today announced that it has entered into a settlement and license agreement with Hoffmann-La Roche Inc. that will resolve pending patent litigation related to XELODA® Tablets, 150 mg and 500 mg, known generically as Capecitabine Tablets. This product is an orally administered chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers.
Hoffmann-La Roche Inc. had filed patent infringement suit against Accord Healthcare and Intas Pharmaceuticals Ltd. following Accord's submission to the U.S. Food and Drug Administration of an Abbreviated New Drug Application (ANDA) for a generic version of XELODA® Tablets.
As part of the agreement, Hoffman La Roche Inc. has granted Accord a license to enter the U.S. market with a generic version of XELODA® Tablets ahead of its exclusivity period. Pursuant to the agreement, pending litigation would be dismissed. All other terms and conditions of the settlement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission.
XELODA® Tablets had U.S. sales of approximately $706.2 million for the 12 months ending Dec 31, 2012, according to IMS Health.
Intas Pharmaceuticals Ltd. and its wholly owned subsidiary Accord Healthcare Inc., today announced that it has entered into a settlement and license agreement with Hoffmann-La Roche Inc. that will resolve pending patent litigation related to XELODA® Tablets, 150 mg and 500 mg, known generically as Capecitabine Tablets. This product is an orally administered chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers.
Hoffmann-La Roche Inc. had filed patent infringement suit against Accord Healthcare and Intas Pharmaceuticals Ltd. following Accord's submission to the U.S. Food and Drug Administration of an Abbreviated New Drug Application (ANDA) for a generic version of XELODA® Tablets.
As part of the agreement, Hoffman La Roche Inc. has granted Accord a license to enter the U.S. market with a generic version of XELODA® Tablets ahead of its exclusivity period. Pursuant to the agreement, pending litigation would be dismissed. All other terms and conditions of the settlement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission.
XELODA® Tablets had U.S. sales of approximately $706.2 million for the 12 months ending Dec 31, 2012, according to IMS Health.