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.
Natco has filed an abbreviated new drug application seeking the FDA’s approval for marketing generic versions of Fosrenol in 500mg, 750mg and 1gm, dosages. Shire has 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.
Rajeev Nannapaneni, COO of Natco Pharma, said: “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 US.”