Hyderabad-based Natco Pharma Limited has joined hands with Mumbai-based Lupin Limited to jointly commercialize generic equivalents of lanthanum carbonate tablets. Lanthanum carbonate tablets are used in cases of kidney failure and would facilitate phosphate absorption.
Lanthanum carbonate tablets are sold under the brand name of Fosrenol by the innovator - Shire, plc. Natco had filed an abbreviated new drug application (ANDA) seeking US FDA's approval for marketing generic versions of Fosrenol in 500 mg, 750 mg and 1gm, dosages. Shire had filed two law suits against Natco for infringement of patents for Fosrenol, which Natco is defending.
Natco and Lupin believe that they are among one of the first-to-file for this product, which may lead to 180 days exclusivity. The global sales of Fosenol amounted to US$108 million as of December, 2008.
Rajeev Nannapaneni, director & chief operating officer of Natco Pharma Limited has commented, "This alliance brings together a strong philosophy of working together to maximize opportunities in an increasingly competitive generic business. We are very happy to be associated with Lupin, given their intellectual property management competencies and market strengths in the United States."
Nilesh Gupta, group president and executive director, Lupin Limited said, "This alliance creates synergies that will enable portfolio expansion and would contribute to consolidating Lupin's presence in the US markets. Lupin's proven IP management capabilities, marketing reach and expertise will enable the alliance partners to strengthen their interests and create future growth drivers in the United States."