Just as we were going to press, word arrived that the FDA had approved the first generic atorvastatin calcium. Ranbaxy Laboratories got the okay on generic Lipitor on Wednesday, and the company launched the product on Thursday. (Ohm Laboratories in New Brunswick, NJ, is doing the actual manufacturing.)
This clearly does not, however, signal the end of one of the greatest acts in pharmaceutical history. A new performance is already underway, though I suspect it will resemble the clown car at the circus more than Olivier’s Hamlet. Pfizer has spent a year preparing to battle the generics on every front— with aggressive copay subsidies, access agreements, and authorized generics. Meanwhile, some pharmacy benefit managers are lining up behind Pfizer and some behind the generics—all while their trade association lashes out against copays generally and hints that they signal the end of Western civilization. The generics-makers themselves have joined in the struggle of all against all, with Watson allied in a profit-sharing deal with Pfizer, while Ranbaxy pays Teva to stay out of the melee for a little while.
If anyone can figure out how to rappel down the face of the patent cliff to a soft landing, it should be Pfizer—the incentives and resources are both enormous. (Maybe they can even build a switch-back highway, a route down to a comfortable blockbuster- retirement community in the valley.)
About that cliff, though: It’s worth noting that Lipitor is a member of the Class of 1996—the unprecedented tsunami of new product approvals generated by the biotech revolution (which galvanized conventional drug research) and the first Prescription Drug User Fee Act. Given a 20-year patent life, the cliff is the natural tail end of that burst of pent-up creativity…not a symptom of moral failure. Deal with it.
PM360 mourns the passing of Bob Gerbig, 66, the advertising visionary who founded Gerbig, Snell/Weisheimer & Associates (GSW). He died Nov. 28 in Powell, OH. Bob left Abbott in 1977 to start GSW with partners Rick Weisheimer and Chris Snell. He had been a mainstay of healthcare marketing ever since. We will miss him. In lieu of flowers, the family asks that donations be made in his memory to Flying Horse Farms, a camp for children with serious illnesses, at 3 Easton Oval, Suite 330, Columbus, OH 43219 (www.flyinghorsefarms.org).