It’s the end of an era for the pharmaceutical industry. Tomorrow, the most popular prescription drug in the world, Lipitor, is due to go off-patent in the US. And no product looks set to equal or surpass the cholesterol-lowering agent’s peak annual sales of $13.7 billion, which it achieved back in 2006.
Lipitor, known generically as atorvastatin, is used by nearly 9 million Americans and has made Pfizer more than $130 billion globally since its 1997 launch. As the drug stands poised at the edge of a proverbial patent cliff, analysts at EvaluatePharma forecast that the loss of the megablockbuster will rob the New York–based drug giant of its top spot in the pharmaceutical league rankings by revenue. As the expiry looms large, patients, pharmacies and the drug industry are all holding their breaths, waiting to see how the introduction of generic atorvastatin will affect them.
For long-term Lipitor users, the patent expiry should be great news. Although Pfizer is expected to take a huge hit with the loss of Lipitor’s exclusivity — about $10 billion a-year by some estimates — consumers should save big. The generic substitute for Lipitor is expected to eventually cost up to 90% less than Pfizer’s drug, and co-payments are expected to drop from an average of $25 per month to $10, saving patients about $180 per year, according to CBS News. To begin with, the Indian drugmaker Ranbaxy Laboratories will hold the exclusive right to manufacture and sell generic atorvastatin in the US, which should help keep the price of the drug relatively high through mid-2012. New Jersey-based Watson Laboratories will simultaneously sell a licensed generic, which will be manufactured by Pfizer. But after six months, other generic version of atorvastatin could flood the market, triggering prices to plummet, and thereby saving consumers and the US health system a whole lot of money.
But the pharma giant hasn’t ceded defeat to generic manufacturers quite yet. According to the Wall Street Journal, Pfizer is offering to sell Lipitor to US health providers at generic prices for six months if the insurers agree to provide Lipitor instead of knock-off alternatives. They have also signed deals with pharmacy benefit managers to block prescriptions for generic versions of Lipitor. For example, Pfizer has negotiated a deal with Medco Health Solutions to supply Lipitor to all existing customers through its direct mail service, the WSJ reports.
As a result of these deals, Consumer Reports writes that patients with private drug coverage, from companies such as UnitedHealth and Medco, will get a better deal by staying on Lipitor, rather than switching to the generic pill. For those covered by the government’s Medicare plan, however, different carriers have different policies. For example, Cigna RX1 and CVS Caremark Value have also signed deals with Pfizer and reduced Lipitor co-pays by up to a tenth of the original price. Others such as First Health Part D Premier have dropped Lipitor completely and are only covering generic atorvastatin.
The big question for analysts is whether people will embrace the new generic versions of atorvastatin on the market or whether they’ll stick with the tried-and-tested brand-name stalwart of the medicine cabinet. The US Food and Drug Administration states that generic drugs must contain the same active ingredients as their branded versions, but consumers and physicians tend to believe generics are inferior, according to ABC News. Despite this, the substantial price drop and the widespread use of generic atorvastatin in countries where Lipitor is already off-patent, such as in Canada, should sustain popularity of the generic in the US.
Other big patent expirations this month include blood pressure drug Caduet (amlodipine), HIV drug Combivir (lamivudine) and Solodyn (minocycline) for severe acne. There are at least ten more expirations to look forward to in 2012, including anti-anxiety pill Lexapro (escitalopram) and the bloodthinner Plavix (clopidrogel). “The industry is truly in crisis mode,” Ken Kaitin, director of the Tufts Center for the Study of Drug Development in Boston, told Nature.
Knowing that it’s not alone might sugar-coat things a bit for Pfizer. But the loss of Lipitor will still be a bitter pill to swallow.
Image: Panthro via Wikimedia Commons