Outlook for generic equivalent of Pfizer's Lipitor; how will US exclusivity resolve? asks law firm HPM
2011 is shaping up to be an interesting year in the Hatch-Waxman world, and all eyes seem to be focusing on what will happen with Ranbaxy’s purported (sole) 180-day exclusivity for a generic version of the mega-blockbuster drug Lipitor (atorvastatin calcium) tablets marketed by the world’s biggest drugmaker Pfizer, says US law firm Hyman, Phelps & McNamara’s Kurt Karst writing on its FDA Law Blog.
Will Indian drugmaker Ranbaxy (which is 64% owned by Japan’s Daiichi Sankyo) launch in November 2011 (pursuant to a patent settlement agreement) and trigger its pre-Medicare Modernization Act (MMA) 180-day exclusivity? Will the exclusivity remain “parked”? Or will the company be stripped of its exclusivity or otherwise work out a deal to relinquish it? A recent BernsteinResearch analyst report tries to address these questions and more, notes Mr Karst.
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