Pfizer tactic aims to head off Lipitor competition
Pfizer’s plan to sell Lipitor (atorvastatin) directly to consumers under a partnership with Diplomat Specialty Pharmacy takes a detour from branded drug manufacturers’ previous tactics and could represent a new way for them to head off competition from generics.
(THE NEWS: Pfizer to sell Lipitor directly by mail. For the full story, click here.)
Under the Hatch-Waxman Act of 1984, the first manufacturer to file with the Food and Drug Administration for approval of a generic version of a drug is entitled to 180 days in which to compete directly with the branded version once the FDA gives the generic the green light. After that, the FDA can approve a generic version from any company. When this happens, the drug becomes commoditized and the price decreases, often forcing the branded drug company to stop manufacturing it altogether.
Because generic competition is bound to hit their sales, branded drug companies have historically sought to create a third competitive front by introducing an authorized generic, which is essentially the branded drug sold under its generic name at a reduced price, usually through a third-party company. Pfizer already has done this with Lipitor, under a partnership with Watson Pharmaceuticals.
Assuming everything goes as planned, Ranbaxy Labs will launch its generic version of Lipitor on Wednesday, as experts have predicted and as the company’s executives have said. At the same time, according to published reports, some experts have said issues that arose at two of the company’s Indian manufacturing plants in 2008 could pose problems for the launch, and they have speculated that Ranbaxy may launch the drug under a partnership with Teva Pharmaceutical Industries. Whatever the case may be, generic atorvastatin will face additional competition from Watson. But now, Pfizer is further complicating the game.
In addition to the Pfizer-Diplomat deal, The New York Times reported earlier this month that Pfizer had made a deal with pharmacy benefit managers timed to coincide with Ranbaxy’s exclusivity period, whereby the PBMs would instruct pharmacies to fill prescriptions with branded Lipitor and then charge customers the same co-pay that they would for the generic version. The Times quoted critics of the deal as saying that while patients would be charged the lower co-pay, payers would still have to pay the full price.
Like many drug makers, Pfizer has sought to prepare for the patent cliff by transitioning away from the blockbuster model of drug development and focusing more on specialty drugs, especially biologics for difficult-to-treat conditions like autoimmune disorders and cancers. But the key word here is “transition,” not “leap”: Lipitor still represents a major part of the company’s business, so it would behoove Pfizer to try and get as much out of it as possible before Ranbaxy’s 180-day exclusivity period ends and the market is flooded with possibly dozens of generic versions.