1-4 September, 2006 Pragati Maidan, New Delhi, India
    Ranbaxy Gets Bristol-Myers Drug`s EMR


Ranbaxy Laboratories Ltd has hit a bull`s eye in the US-based generic market. US- based pharma company Andrx Corporation has transferred its exclusive marketing rights (EMR) in the US market for the generic version of Bristol-Myers Squibb`s hyper-tensive drug `Monopril` to Ranbaxy. As per the agreement, Ranbaxy will share part of its revenues from this drug with Andrx.

Ranbaxy circles said that the company has already received the tentative approval for Monopril`s generic version in September 2004 and has plans to launch the product once it receives the final US FDA approval. Incidentally, the company has also received the approval for Monopril`s complementary product, Fosinopril tablets.

Industry analysts feel that this EMR will aid Ranbaxy to garner a significant market share in the highly potential hypertension US drug market with the two complementary formulations. According to IMS data, US sales of Bristol-Myers Squibb`s blockbuster product Monopril for the last 12 months were approximately $24 million.

Andrx Corporation has recently received the US FDA approval for its Abbreviated New Drug Application (ANDA) for bio-equivalent versions of Monopril-HCT (R)(Fosinopril Sodium and Hydrochlorothiazide tablets).

The US FDA awarded Andrx a 180-day period of EMR for this product, as per regulatory norms. But Andrx had said in a statement that it was unable to launch the product due to raw material issues with its supplier. Consequently, Andrx entered into an `Exclusivity Transfer Agreement` with Ranbaxy`s US subsidiary, Ranbaxy Pharmaceuticals Inc.

A statement issued by Andrx says that the company agreed to transfer 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. Andrx`s 180-day EMR period commenced when the US drug major Bristol-Myers Squibb failed to appeal the decision of the United States District Court that the Andrx product did not infringe the patents that corner its Monopril-HCT(R) product.

Date: 18-Dec-2004

Back