The inability of US generics maker Andrx Corporation to produce cardiovascular drug Monopril-HCT on its own has given Ranbaxy Laboratories an opportunity to add over Rs 10 crore (Rs 100 million) to its bottomline.
Andrx was recently awarded 180-day marketing exclusivity for the drug by the US Food and Drug Administration after it successfully challenged the patent of Bristol-Myers Squibb.
Andrx has transferred its marketing exclusivity rights in favour of Ranbaxy Pharmaceuticals Inc, the US arm of India's largest pharmaceutical company.
Bristol-Myers Squibb clocked sales of $24 million (Rs 108 crore approximately) in the trailing 12 months for Monopril-HCT in the US.
A Mumbai-based pharmaceutical sector analyst expects Ranbaxy to record sales of $8-9 million (Rs 40 crore approximately) in the exclusivity period, assuming that Andrx will not launch its own version.
"Since it will have to share the profits with Andrx, we do not expect the deal to contribute significantly to Ranbaxy's bottomline. There could be an incremental contribution of about $2-3 million (Rs 13 crore approximately)," he added.
A Ranbaxy spokesperson was not available for comment. However, sources close to the company confirmed the development.
Andrx said in a release posted on its website: "Due to Andrx's inability to launch the product at this time as a result of raw material issues with its supplier, it had entered into an 'exclusivity transfer agreement' with Ranbaxy Pharmaceuticals Inc, which received a tentative approval for this product on September 1, 2004. Andrx has 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."
The FDA has approved Andrx's abbreviated new drug application for bioequivalent versions of Monopril-HCT(R) (fosinopril sodium and hydrochlorothiazide tablets, 10mg/12.5mg and 20mg/12.5mg).
