Financial Daily from THE HINDU group of publications
Saturday, Dec 11, 2004
Marketing - Trends
Andrx transfers EMR of cardiovascular drug to Ranbaxy's US arm
New Delhi , Dec. 10
US-based Andrx Corporation has decided to transfer its exclusive marketing rights of the generic version of the cardio-vascular drug Monopril HCT to Ranbaxy Pharmaceuticals Inc, the US subsidiary of Ranbaxy Laboratories Ltd.
According to a statement on Andrx Corp's Web site, the US Food and Drug Administration had approved its abbreviated new drug application (ANDA) for bioequivalent versions of Monopril-HCT (fosinopril sodium and hydrochlorothiazide tablets). It had awarded the company a 180-day period of marketing exclusivity for the product.
However, due to the US company's inability to launch the product at that time, as a result of raw material issues with its supplier, Andrx entered into an exclusivity transfer agreement with RPI. Ranbaxy too received a tentative approval for this product on September 1.
In exchange for the transfer of its exclusive marketing rights, Ranbaxy has agreed to share its profits for a certain period of time.
"Ranbaxy anticipates its product will be launched promptly following receipt 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," according to the statement.
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 covers the Bristol-Myers' Monopril-HCT product. The total sales for the drug during the last 12 months in the US market have been estimated at $24 million.
According to analysts tracking the sector, there is no clarity on the exact period for which Ranbaxy will be exclusively marketing the product. Also, Ranbaxy's strategy for its own version of the drug is unclear. Officials at Ranbaxy refused to comment on the issue.
"One has to see how many other generic companies have filed ANDA and at what stage those applications are. There are also issues related to how Ranbaxy will be able to retain high margins," said industry analysts.
Normally, the entry of generics, as in the case of Cefuroxime Axetil (Ceftin), leads to major price cuts, thus eroding margins.
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