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US subsidiary of Ranbaxy on Thursday launched Atorvastatin (generic Lipitor). As per Ranbaxy and Pfizer’s June 2008 agreement, the Indian company was supposed to launch Caduet, a combination of Lipitor and Norvasc in the US beginning November 30.
After Ranbaxy’s rival Mylan launched generic Caduet tablets in multiple strengths on Thursday, there were fears that the former might not start the sale at all. Caduet is expected to give Ranbaxy around $50 million in revenues and add Rs 3 in earnings per share.
A Ranbaxy spokesperson told Financial Chronicle: “The launch of generic Caduet will dovetail Atorvastatin launch.” He did no give out any date. It is likely that most of Ranbaxy’s strategy to capture the US market for Lipitor having $5 billion annual sales has superceded generic Caduet interests.
Pfizer’s Lipitor deal sealed by former owner Malvinder Singh in 2008 also included Caduet in the US as Ranbaxy was the first to file the generic product application. According to medical data provider IMS Health, Caduet tablets had approximately $340 million sales in the US in 12 months ending September 30.
Analysts from Nomura and UBS had talked about Ranbaxy not getting approval for generic Caduet. Nomura analyst Saion Mukherjee on Thursday said that Ranbaxy has so far not announced approval for generic Caduet that was to be launched as per settlement. “Mylan has announced approval of the launch of Caduet as per its settlement terms. In our view, there remains a possibility that Ranbaxy has forfeited exclusivity as it hasn’t obtained tentative approval within the mandated 30-month period for post (Medicare Modernisation Act) MMA filings,” said Mukherjee.
Before 2008 settlement between Ranbaxy and Pfizer, both companies were engaged in pitched battle on Caduet. But, the pact changed all of that as the suits were dismissed in the US and Ranbaxy promised not to contest the validity of Pfizer’s patents.
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