Generic Lipitor Approved
Written by Faith Anderson on December 2, 2011
Lipitor Sales to Plummet as Generics Lower Price
In what has been called the biggest event in the pharmaceutical industry this year, billions of dollars in annual U.S. sales of Lipitor are at stake in the largest-ever switch from a brand name to generic. Lipitor had peak sales of $13 billion and still brings in nearly $11 billion for New York-based Pfizer. Lipitor’s U.S. revenue will begin to decline immediately, and will plummet with the introduction of more generics next June. Atorvastatin is a statin, a type of drug that lowers bad cholesterol and blood fats called triglycerides by blocking an enzyme in the liver. Along with a low-fat diet, atorvastatin can reduce the risk of stroke, heart attack, chest pain and some types of heart surgery. It can also raise levels of good cholesterol in the blood.
Other Lipitor Generics to Enter Market June 1
Two generic versions of Lipitor, priced about 30% and 50% less than the brand name drug, were originally expected to hit pharmacies starting Wednesday, offering some savings to the three million Americans taking the medication to reduce their cholesterol. Watson Pharmaceuticals Inc. began distributing an authorized generic on Wednesday, and under the company’s deal with Pfizer, Pfizer will receive an estimated 70% of those sales. Under U.S. patent law, however, because Ranbaxy was the first to successfully challenge Pfizer’s Lipitor patent, it has the sole right to compete with brand-name Lipitor and Watson’s generic for the first 180 days after the patent ends. Beginning on June 1, Teva Pharmaceuticals USA Inc. and at least two other companies are expected to sell their own generic Lipitor drugs. At that point, the price for all the generics should plummet to about 20% of Lipitor’s current price, which is approximately $115 to $160 per month, depending on dosage.
Poor Quality in Ranbaxy Facilities Spurs FDA Contamination Concerns
Rumors had been circulating over the past week that Ranbaxy was close to a financial settlement with the FDA that would include approval to sell generic Lipitor. “This medication is widely used by people who must manage their high cholesterol over time, so it is important to have affordable treatment options,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “We are working very hard to get generic drugs to people as soon as the law will allow.” In September 2008, the FDA blocked imports of more than 30 Ranbaxy generic medications, including two older generic cholesterol drugs, due to concerns about poor quality in two Ranbaxy factories. According to the FDA, the agency found problems that could result in contamination and allergic reactions, noting that the company had not addressed the issues.