Pharmacy

Lupin Ltd and Natco Pharma have formed an alliance to jointly commercialize generic lapatinib ditosylate tablets used for the treatment of breast cancer in the US market. Lapatinib ditosylate tablets are sold under the brand name Tykerb in the US market. The patent of Tykerb is with Glaxo.

Natco had filed an Abbreviated New Drug Application (ANDA) seeking US Food and Drug Administration (US FDA) approval for marketing generic equivalent of Tykerb® in 250 mg tablets. Lupin, the 5th largest and the fastest growing top 5 generics player in the US (by prescriptions), the only Asian company to achieve that distinction along with Natco, believes that they are first-to-file an ANDA containing a Paragraph IV certification for Lapatinib. Tykerb® had sales of $113.6 million as of March 2011 according to IMS health.