Lipitor going generic garners attention far and wide

WHAT IT MEANS AND WHY IT'S IMPORTANT — With annual sales gaining on the $8 billion mark in the United States alone, according to IMS Health, Lipitor (atorvastatin) is the top-selling drug in the world, and the price markdown that Ranbaxy Labs’ launch (and subsequent generic launches) will bring, greatly will expand its accessibility. So it’s no surprise that it has attracted so much media attention over the past few weeks.

(THE NEWS: Senators look into Pfizer-PBM deal for Lipitor. For the full story, click here)

Pfizer wants to profit from the drug for as long as it can before May 31, 2012, when Ranbaxy’s market-exclusivity period ends and atorvastatin calcium becomes fair game for any generic drug maker. But some of Pfizer’s methods — particularly, partnering with PBMs to make pharmacies dispense branded Lipitor and charge customers the same price as the generic — already are attracting Capitol Hill’s scrutiny.

And that’s to say nothing of the attention that the country’s two biggest PBMs, Express Scripts and Medco Health Solutions, already were getting from Congress with their proposed merger. The Pfizer deal begs a question: what sort of effect would a combined ESI-Medco mega-PBM’s ability to restrict generic dispensing have on what payers — and ultimately taxpayers and people paying into health plans — spend on health care?

Other plans include a partnership with Diplomat Specialty Pharmacy to sell Lipitor directly to consumers through the mail and an attempt at an over-the-counter switch.

It’s one thing when a generic company launches a version of a drug that’s already been on the market for years or challenges the patent on a drug with less-than-blockbuster annual sales. But Lipitor is much bigger, not only in terms of its sales figures, but what the expiration of its patent protection symbolizes: the end of the blockbuster era.

Like many drug makers, such as Merck and Bristol-Myers Squibb, Pfizer has prepared itself by transitioning into specialty and biotech drugs, but holding on to Lipitor for as long as it can will buy it time before the blockbuster era ends.