Lupin inks alliance with Natco Pharma

23 Jun 2011 Evaluate

Lupin and Natco Pharma has formed an alliance to jointly commercialize generic equivalent of Glaxo’s Tykerb (Lapatinib ditosylate) tablets. Natco has filed an abbreviated new drug application (ANDA) seeking USFDA’s approval for marketing generic equivalent of Tykerb 250 mg tablets.

Lupin and Natco believe that they are first-to-file an ANDA containing a Paragraph IV certification for Lapatininb. Tykerb has sales of $113.60 million as of March 2011 based on IMS Health sales data.

Recently, Lupin’s US arm Lupin Pharmaceuticals, (LPI) had been granted final approval by the United States Food and Drugs Administration (USFDA) for the Company’s Abbreviated New Drug Application (ANDA) to market a generic version of Ortho McNeil’s Levaquin (levofloxacin) tablets. Commercial shipment of the product had commenced.

Lupin an innovation led transnational pharmaceutical company producing a wide range of quality, affordable generic and branded formulations and APIs. The Company today has significant presence in Cardiovascular (prils and statins), Diabetology, Asthma, Pediatrics, CNS, GI, Anti-Infective and NSAIDs in addition to holding global leadership positions in the Anti-TB and Cephalosporins space.

NATCO, in addition to research and manufacture of pharmaceuticals for itself, also contracts for expertise and facilities to Indian and multinational companies for R & D and manufacturing projects.

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