RIP, More or Less: Brand Name Lipitor

By bmartin on November 30, 2011 9:36 AM | Permalink

Today marks the generic availability of Pfizer's Lipitor, the blockbuster drug to beat all blockbuster drugs.

Duff Wilson of the NYT lays out how Pfizer is leveraging its short-term losses (for instance, it will get 70% of generic maker Watson's profits).

And Forbes's Matthew Herper gets nostalgic for the era of the widely prescribed money maker ("Why There Will Never Be Another Drug Like Lipitor"). Specifically he provides a concise history of Lipitor's rise and plateau; but he unfortunately omits one of the most interesting and important points of the early Lipitor campaign.

When first approved by the FDA in 1996, Lipitor was only indicated to reduce LDL cholesterol; it had not been shown to prevent clinical vascular events like its 4 existing statin competitors at the time. Nevertheless, trial data showed that Lipitor reduced LDL cholesterol by a relatively greater percentage than the other statins. And because clinicians believed (and still do) that LDL cholesterol is directly linked to the risk of vascular events, Pfizer was able to leverage this belief into ever-escalating sales during the next several years without having data to show that Lipitor actually reduced the risk of vascular events.* Clinicians made the a-to-b-to-c connection with prescription-writing alacrity.

Oh BTW, the generic name of Lipitor: atorvastatin.

* Lipitor wasn't approved by the FDA for this indication until 2004.

Delayed update (12/10/11): In an intriguing NEJM Perspective piece, Jackevicius et al expect that atorvastatin will "dominate" the statin market as a result of switching from generic simvastatin and branded Crestor. Specifically, in 3 years, they expect the market share of atorvastatin to reach 44%. They also estimate, on the basis of experience with simvastatin (which went generic in 2006), that the price of generic atorvastatin will be about 50% of the price of branded Lipitor, after the 6-month exclusivity period ends for the first generic manufacturer.

The projected overall cost savings by 2014, owing to the generic availability of atorvastatin: $4.5 billion annually; when factoring in the aging of the population, add another $30 million. These projections assume the "rapid availability and timely uptake of generic atorvastatin," which may be delayed thanks to industry maneuvers between Pfizer and generic drug makers (which are designed to limit competition). Pfizer is also reportedly planning to ask the FDA to approve an OTC version of Lipitor at some unspecified date.