The United States Food and Drug Administration has approved Andrx Corporation's ANDA for bioequivalent versions of Monopril-HCT (Fosinopril Sodium and Hydrochlorothiazide Tablets, 10mg/12.5mg and 20mg/12.5mg). According to IMS data, US sales of Monopril-HCT for the trailing 12 months were approximately $24 million.
The FDA awarded Andrx a 180-day period of marketing exclusivity for this product. Due to Andrx's inability to launch the product at this time as a result of raw material issues with its supplier, Andrx entered into an Exclusivity Transfer Agreement with Ranbaxy Pharmaceuticals Inc., which received a tentative approval for this product on September 1, 2004.
Andrx agreed to waive its marketing exclusivity rights exclusively to Ranbaxy in exchange for a share of Ranbaxy's profits resulting from the sales of this product for a certain period of time. Ranbaxy anticipates its product will be launched promptly following receipt by Ranbaxy of final FDA approval of its ANDA for this product. Under the agreement, Andrx is entitled to launch its own version of this product, which Andrx will pursue. Andrx's 180-day marketing exclusivity period commenced when Bristol-Myers Squibb Company failed to appeal the decision of the United States District Court that the Andrx product did not infringe the patents that cover Bristol-Myers' Monopril-HCT product, the company release said.