Lupin Ltd has entered into an agreement with Baxter Healthcare Corporation, a global medical products US company, for exclusively marketing its generic version of ceftriaxone sterile vials for injection in the US. This alliance provides Lupin access to the US ceftriaxone vial market, as well as the potential for other delivery systems.
Lupin intends to launch the product in the US after product patent expiry in July 2005. The market size of Rocephin in the United States is US$700 million as per IMS.
Earlier this fiscal year, Lupin received USFDA approval for its ANDA for ceftriaxone vials for injection 250 mg, 500 mg, 1g and 2g, the generic equivalent of Rocephin marketed by Roche. Lupin is the only company with an ANDA approval from the USFDA for ceftriaxone. The company will manufacture the product in its facility in Mandideep, India, one of the few facilities to receive USFDA approval for manufacture of sterile vials for injection, as well as sterile cephalosporins API.