Lupin Limited and Natco Pharma announced an alliance to jointly commercialize generic equivalent of Glaxo's Tykerb (lapatinib ditosylate) tablets. Natco had filed an Abbreviated New Drug Application (ANDA) seeking US FDA's approval for marketing generic equivalent of Tykerb 250 mg tablets.
Natco and Lupin believe that they are the first-to-file an ANDA containing a paragraph IV certification for lapatinib. Tykerb had sales of $113.6 million as of March 2011 (IMS).
Lupin Ltd is an innovation led transnational pharmaceutical company producing a wide range of quality, affordable generic and branded formulations and API's.