Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), Gurgaon, India, announced an agreement with Validus Pharmaceuticals LLC (Validus) to market and distribute an authorized generic version of Rocaltrol(R) (calcitriol) in both softgel capsules and an oral liquid formulation. Overall market sales for calcitriol softgel capsules and oral liquid were $70 million (IMS - MAT: June 2009).
Rocaltrol(R) is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure not yet on dialysis, and in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. Rocaltrol(R) is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypo-parathyroidism.
"Ranbaxy was very pleased to be selected by Validus as their distribution partner for an authorized generic version of Rocaltrol(R). This product represents an excellent commercial opportunity for Ranbaxy which will increase our visibility and presence in the U.S. healthcare system. We look forward to a long and prosperous partnership with Validus," said Jim Meehan, Vice President of Sales and Distribution for RPI.
Ranbaxy will launch product immediately to all classes of trade in the U.S. market, and expects to be the only generic company offering all forms and strengths of generic Rocaltrol(R).