Several analysts have taken a stab at the will-Ranbaxy-launch-generic-Lipitor question. The conclusion? India's Ranbaxy Labs may just pull it off. But then again, it might not. And even if it does, the penalties Ranbaxy may have to pay to resolve its longstanding regulatory problems could make a Lipitor victory less sweet.
Nomura Holdings figures Ranbaxy could resolve its dispute with the FDA in time to launch its version of Pfizer's top-selling cholesterol drug--and take advantage of its 180-day exclusivity. "We believe Ranbaxy is likely to launch Lipitor on its own, as scheduled, close to November 30," Nomura's Saion Mukherjee and Aditya Khemka told Bloomberg. The analysts acknowledged that Ranbaxy didn't comment specifically on its Lipitor copy when it released third-quarter numbers, but said executives appeared confident about capitalizing on their exclusivity rights.
But Credit Suisse's Fumiyoshi Sakai and Toshiyuki Tateno weren't so sure. "Though it appears more confident that problems have been resolved, the situation remains unclear," they said in a note to investors (as quoted by the news service). The two Tokyo-based analysts also put a pencil to the effects of possible FDA fines stemming from Ranbaxy's manufacturing problems: Less than $300 million would be best-case, while $500 million or more would more or less cancel out the financial benefits of those exclusivity rights.
- read the Bloomberg analysis
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