Dr. Reddy’s Laboratories (RDY) has been busy launching generics and the recent U.S. launch of a generic version of Novatis AG’s (NVS) over-the-counter (OTC) drug, Prevacid, was the second one in less than a week. The U.S. Food and Drug Administration (FDA) approved the Abbreviated New Drug Application (ANDA) for 15 mg formulation of the generic drug.
Prevacid is approved for the treatment of acid reflux disease and heartburn. According to the data of SymphonyIRI InfoScan Reviews, Prevacid sales amounted to about $115 million for the twelve months ended March 31, 2012.
Last week, Dr. Reddy’s announced the U.S. launch of a generic version of Bristol-Myers Squibb & Co.’s (BMY) blood thinner, Plavix. The FDA approved the ANDA for 75 mg and 300 mg formulations of the generic version of the drug. Plavix lost patent exclusivity in the U.S. on May 17, 2012.
Since Dr. Reddy’s was among the first few companies to submit an ANDA for generic Plavix, it has the 180 days of marketing exclusivity for the 300 mg formulation.
According to the IMS Health data, Plavix sales in the U.S. amounted to about $6.74 billion for the twelve months ended March 31, 2012.
Our View
We currently have a Neutral recommendation on Dr. Reddy’s. We believe that generic launches will continue to contribute towards Dr. Reddy’s Global Generics segment’s revenues, which climbed 32% to $1.38 billion in the first quarter of 2012. Primary contribution came from North America (up 68%), Russia and other CIS (Commonwealth of Independent States) markets (up 22%) and India (up 11%). Growth was mainly driven by new generic launches and was aided by an increase in the sales volume.
However, in Europe, sales declined 2%, primarily due to exchange rate fluctuation and the pricing pressure in the German market.
BRISTOL-MYERS (BMY): Free Stock Analysis Report
NOVARTIS AG-ADR (NVS): Free Stock Analysis Report
DOCTOR REDDYS (RDY): Free Stock Analysis Report
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