Watson Pharmaceuticals signed in July 2009 a marketing agreement with GeneraMedix for the exclusive U.S. marketing rights if the drug, which will be called Nulecit.
Nulecit is the first bioequivalent and therapeutically equivalent alternative to Ferrlecit, according to Watson.
Nulecit is approved for the treatment of iron deficiency anemia in adults and children age six years or older undergoing chronic hemodialysis who are receiving supplemental epoetin therapy.
"Watson's Brand sales team is uniquely positioned to effectively maximize the opportunities of this value brand offering, given our experience in marketing injectable iron products," said Fred Wilkinson, Executive Vice President, Global Brands, at Watson. "Nulecit offers the nephrology community a value brand that is bioequivalent to the innovator product, with the added convenience of packaging in glass vials."
In the bioequivalence study, which involved 240 healthy volunteers, Nulecit and Ferrlecit showed comparable concentrations of total serum iron and transferrin-bound iron over 36 hours, according to Watson. Each 5 mL glass vial of Nulecit contains a 62.5-mg single dose (12.5 mg of elemental iron per mL). Additionally, data supports stability of Nulecit in both syringes and saline bags.
"A vial dosage form of sodium ferric gluconate is an important step forward in the treatment of patients with IV iron vs. the old ampule," said Rajiv Agarwal, a board certified nephrologist and professor of medicine at Indiana University School of Medicine. "Having the 62.5 mg vial is convenient for ongoing or continuous therapy, which is our standard with dialysis patients today and may help to control costs by optimizing delivery and minimizing waste."
