Natco Pharma Limited, a Hyderabad-based manufacturer of integrated pharmaceutical and bulk chemicals, has collaborated with Mumbai-based Lupin Limited to jointly commercialise generic equivalents of Lanthanum Carbonate tablets.
Lanthanum Carbonate tablets, indicated for the treatment of kidney failure and would facilitate phosphate absorption, are currently sold under the 'Fosrenol' brand by its innovator Shire Plc.
Natco had filed an abbreviated new drug application (ANDA) seeking the US Food and Drug Administration’s (US FDA) approval for marketing generic versions of Fosrenol in 500mg, 750mg and 1gm dosages. Shire Plc had filed two law suits against Natco for infringement of patents for Fosrenol, which the latter 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 Fosrenol amounted to $108 million as of December 2008.
“This alliance brings together a strong philosophy of working together to maximise opportunities in an increasingly competitive generic business. We are happy to be associated with Lupin, given their intellectual property management competencies and marketing strengths in the US,” Rajeev Nannapaneni, director and chief operating officer of Natco, stated in a release.