Generic Atorvastatin in US This Month

November 03, 2011

November 3, 2011 (New York, New York) The pharmaceutical world will be turned upside down later this month when the lipid-lowering agent atorvastatin (Lipitor, Pfizer), which has claimed the number-one spot in drug sales for the past five years [1], loses its patent protection in the US.

Lipitor had sales last year of $10.7 billion, and Pfizer says that 17 million patients have been prescribed the drug in the US [1]. The drug loses its patent protection in the US on November 30, 2011, when the generic company Ranbaxy Laboratories is expected to launch its generic product.

Ranbaxy has six months of marketing exclusivity for its generic form of atorvastatin in the US, but Pfizer will also introduce its own "authorized" generic, through Watson Pharmaceuticals. In addition, Pfizer is understood to have made deals with certain pharmacy-benefit management companies to sell brand-name Lipitor at a lower price, in a bid to retain some of the market share. It has also launched a "Lipitor for you" program, which includes a card limiting a patient's copayment to $4, valid until the end of 2012, with the company reimbursing the pharmacy the remaining copayment value.

Even so, the price of the drug will reduce substantially, as will Pfizer's market share, which has led to large-scale job losses at the company.

Good News for Patients

But Pfizer's loss is a massive gain for patients, who will now be able to access a highly potent statin for a lot less. It is estimated that a 30-day supply of generic atorvastatin will cost around $30 to $50, compared with the current price of $200 for Lipitor. After Ranbaxy's six-month exclusivity is over next May, many other generics will become available, which will cause a further drop in price.

Dr Roger Blumenthal (Johns Hopkins University, Baltimore, MD) pointed out to heartwire that while several other statins are already available as generics (including simvastatin, pravastatin, fluvastatin, and lovastatin), atorvastatin is more potent and can achieve greater reductions in LDL cholesterol more easily and is therefore a popular choice. Blumenthal estimates that atorvastatin accounts for about half the statin population at present, and the numbers of patients taking this drug should now increase further as it becomes more affordable.

Dr William Boden (University at Buffalo Schools of Medicine, NY), told heartwire that the availability of generic atorvastatin will bring "big changes" to the prescribing of statins. "Even though we have had four other generic statins available for some time, doctors still prescribe Lipitor. This is because there are a lot of data supporting its use; the 80-mg dose has emerged as the agent of choice for ACS patients, and Pfizer has heavily promoted the product. There is now a reflex attitude that this is the best agent to use."

Rosuvastatin to Take a Hit

Boden notes that another casualty of the arrival of generic atorvastatin will be rosuvastatin (Crestor, AstraZeneca). "While rosuvastatin is probably a little more powerful, it doesn't have quite as much data, and it hasn't achieved as much market penetration as Lipitor. We have switched to rosuvastatin because our hospital formulary negotiated a good price, but this will probably change when generic atorvastatin becomes available. Price is a major driver in these decisions."

But he says from a public-health standpoint, generic atorvastatin is "great news."

"At the moment the most widely prescribed generic statin is simvastatin. This will now change to atorvastatin, as all those patients who can't afford the large copays on the branded product will be able to get it much cheaper. That means more people will be on a more powerful statin, and cholesterol levels in general should be lower."

Already Off Patent in Canada and Spain.

Pfizer told heartwire that the patents had already expired on Lipitor in Canada and Spain, and generics were already available in these markets. For most other European countries, Pfizer has been granted an additional six months' patent protection in return for developing a pediatric formulation, and so generic competition would start in mid-2012.

In the longer term, Pfizer says it is looking at introducing a nonprescription form of Lipitor in the US, but this would not happen until at least 2013 because of the regulatory hurdles needed, the company's CEO, Ian Read, said recently. This will depend on whether the FDA deems an over-the-counter version appropriate. It has previously prevented Merck from selling an OTC version of lovastatin, because of concerns that it wouldn't be used by the right patients. However, an OTC version of simvastatin has been available in the UK since 2004 for people at risk of heart disease (sold under the supervision of a pharmacist).

Pfizer No Longer Number One

Loss of Lipitor patent will knock Pfizer off the top of the perch in terms of pharmaceutical sales. It has enjoyed this pole position for many years, based primarily on Lipitor revenues. It is now thought that Sanofi-Aventis will take first place in 2012, followed by Novartis, with Pfizer relegated to third place, according to a report by EvaluatePharma [3].


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