The mother of all blockbuster drugs – Pfizer's Lipitor – sees the patent on its $13-billion cholesterol medicine expire on November 30. But the moot question is: will Ranbaxy be able to get a slice of that pie?
Drug-maker Ranbaxy has a six-month exclusivity on the product, but with the company still to resolve regulatory concerns over a couple of its manufacturing facilities in India – a shadow of uncertainty has been cast over its exclusivity.
No roadmap yet
Ranbaxy and its Japanese parent Daiichi Sankyo have in the past been confident of being able to launch their generically similar version of Lipitor in November, when the Pfizer patent expires. However, Ranbaxy has not, till Tuesday evening, unveiled a road-map on how it expects to leverage its advantage.
Eyes are now on Ranbaxy to see if it has a plan-B in place to pull off the launch of its version of Lipitor, in the 11th hour.
Industry analysts estimate the opportunity for Ranbaxy at about $650 million. On the eve of the patent expiry of Lipitor, Ranbaxy continues to be tight-lipped on how they plan to launch the generic version of Lipitor.
Delay - Advantage Pfizer
“Every passing day that Ranbaxy delays its launch of generic Lipitor is a gain for Pfizer, the present owner of the drug and Watson, the other company that has an exclusivity on the product,” observes a veteran industry-watcher.
While a section of analysts expect some development tonight (including a settlement with the US regulator – the Food and Drug Administration), others are more magnanimous, and will wait for a plan from the company over the next few days, they say.
Litigation-filled
But Lipitor has always been at the centre of much heart-burn. Ranbaxy had fought a five year cross-country litigation with Pfizer before eventually agreeing to a cease fire and settling the cases in 2008. The timing of the settlement was after Ranbaxy's promoters sold their majority state in the company to Daiichi Sankyo.
Setting the clock back even earlier, the pharma-world has it that Lipitor was a significant reason why Pfizer acquired Warner Lambert, in the first place!