Repaglinide is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with type 2 diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled satisfactorily by diet and exercise alone.
This tentative approval is the bioequivalent to Prandin, a registered trademark of Novo Nordisk Pharmaceuticals. Prandin tablets had US sales of approximately $153 million for the 12-month period ended June 30, 2007, according to IMS Data.
Daniel Movens, Caraco’s CEO, said: “We believe we have a first to file position on Repaglinide, which could result in 180-day marketing exclusivity. The product was filed with a paragraph IV certification that we do not infringe and or that the Novo Nordisk patent is invalid. We are under current litigation with Novo Nordisk and expect a favorable conclusion.”