REMS Daily Archives
Drugmakers prepare for loss of patent protection on Pfizer's Lipitor
Nov 30, 2011Pfizer’s Lipitor (atorvastatin) is scheduled to lose patent protection in the US on Wednesday and it remains uncertain how much of the market share the company can retain and how much will be lost following the introduction of generic alternatives.
The drugmaker’s strategy to retain Lipitor users includes deals with pharmacy benefit managers and health insurance providers to offer discounts to patients for prolonged use of the drug after its patent expires. Pfizer has also contracted with Medco Health Solutions to supply Lipitor at a discounted price through a direct-mail service programme and will offer a similar service through the Lipitor website. In addition, the company has said that it may introduce an over-the-counter variant of the drug.
Sanford Bernstein analyst Tim Anderson estimates that Pfizer can turn a profit of roughly $100 for a 90-day supply of Lipitor, even after paying rebates to insurers and patients, versus approximately $225 before generic competition. He noted that the company can still realise a profit because administrative and advertising costs for the drug will decline. As such, Anderson expects Pfizer’s strategy to boost its earnings per share by approximately 2 percent next year.
David Simmons, Pfizer’s president of emerging markets and established products, noted that the drugmaker will shift resources out of Lipitor, and plans to slowly start running fewer advertisements for the drug. He added that the company will also only keep up its patient co-pay discount programme "Lipitor for You" as long as it generates positive results. "There’s some point of diminishing returns," Simmons remarked.
Simmons also noted that Lipitor "will continue to have a lifespan in China." He estimated that only 9 percent to 10 percent of patients who could benefit from Lipitor in the country were aware of their condition and had been diagnosed, compared with 45 percent to 50 percent in the US and Europe.
While many analysts have lamented the lack of FDA filings for approval of a generic Lipitor, Canaccord Genuity analyst Randall Stanicky noted that to date, approximately 10 applications have been submitted to the agency for generic alternatives.
Charlie Mayr, a spokesman for Watson Pharmaceuticals, which has an agreement with Pfizer to produce an authorised generic version of Lipitor, said the company is scheduled to begin shipping the drug to pharmacies just after midday on Wednesday. Meanwhile, Ranbaxy, which is also entitled to sell generic Lipitor when the product's patent expires, is still awaiting manufacturing approval from the FDA. Shares in the Indian company dropped as much as 3 percent Wednesday amidst the uncertainty on the launch of the drug.
"There’s a lot of uncertainty with Lipitor now and we don’t know when [Ranbaxy's] approval will come," Centrum Broking analyst Ranjit Kapadia said. Sources last week suggested that Ranbaxy was nearing a deal with the FDA that would see the company pay between $350 million and $400 million to settle outstanding regulatory issues. Company spokesman Krishnan Ramalingam said he was unaware of when the FDA decision may arrive.