Global biopharmaceuticals company Bristol-Myers Squibb (BMS) is suing Dr Reddy’s Laboratories (DRL) for infringing its patent on breast cancer drug ixabepilone, sold as Ixempra.
The US-based company has filed a suit in the United States District Court of New Jersey and sought an injunction on DRL’s plans to manufacture and market the generic version of Ixempra.
BMS said in its petition that it had developed and manufactures the Ixempra kit pursuant to New Drug Application No. 022-065, which was approved by the FDA.
The Ixempra kit delivers a microtubule inhibitor, and is indicated for both monotherapy and combination therapy breast cancer treatment. As a monotherapy, the kit is indicated for the treatment of metastatic or locally advanced breast cancer in patients after the failure of an anthracycline, a taxane and capecitabine. As a combination therapy, it is indicated in combination with capecitabine for the treatment of metastatic or locally advanced breast cancer in patients after the failure of anthracycline and a taxane.
Ixempra is said to have a market of $150 million.
The petition comes in the wake of DRL filing an application with the US FDA for manufacturing and marketing generic Ixempra. DRL has also notified the US major on its abbreviated new drug application filing with the FDA for manufacture of Ixabepilone injection.
“Patent challenges is a continuous process and we believe that the petition is a result of once such efforts,” A DRL spokesman said.