India's largest maker of generic drugs won approval Wednesday to sell a generic version of cholesterol blockbuster Lipitor. The world's top-selling drug ever lost U.S. patent protection earlier in the day.
The U.S. Food and Drug Administration said it granted Ranbaxy Laboratories Ltd. approval to sell a generic version of Pfizer Inc.'s Lipitor, called atorvastatin calcium. The last-minute decision ended widespread speculation over the outcome of a delay caused by long-standing manufacturing issues at some Ranbaxy factories.
Ranbaxy confirmed the approval in a statement issued late Wednesday night, noting Lipitor generated $7.9 billion in U.S. sales in the 12 months through September. Ranbaxy spokesman Chuck Caprariello said shipments would begin immediately.
Analysts, pharmacists and others had been watching closely to see whether Ranbaxy would be able to get its generic on the market by the time the patent expired for Lipitor.
That's because quality problems at some Ranbaxy factories, dating to 2006, had led the FDA to block shipments of many of its generic drugs to the U.S. and to hold up approval of any new Ranbaxy drugs.
According to FDA spokeswoman Sandy Walsh, Ranbaxy will be manufacturing the pills under a partnership with Ohm Laboratories in Ohm's New Jersey facility.
Meanwhile, statements issued by both Ranbaxy and by Teva Pharmaceuticals USA Inc. said that under an agreement between the two companies, a portion of the profits from Ranbaxy's sales of atorvastatin during the next six months will be paid to Teva. Ranbaxy said terms of the agreement would not be disclosed.
Denise Bradley, a spokeswoman for Teva, the world's largest maker of generic drugs, said she was not able to disclose either the reason for the deal or the amount of money involved.
With billions of dollars in annual U.S. sales of Lipitor at stake, the largest-ever switch from a brand name to generic drug has been arguably the biggest event this year in the pharmaceutical industry.
Lipitor had peak sales of $13 billion and still brings in nearly $11 billion for New York-based Pfizer. The U.S. revenue will start declining right away, and will plummet with the advent of more generic versions next June.
Two generic versions, priced about 30 percent to 50 percent less than Lipitor, originally had been expected to hit pharmacies starting Wednesday, offering some savings to the 3 million Americans taking the cholesterol-lowering pill.
Watson Pharmaceuticals Inc. began distributing one, an authorized generic, Wednesday under Watson's brand. Under Watson's deal with Pfizer, Pfizer will receive an estimated 70 percent of those sales.
Under complex U.S. patent law, because Ranbaxy was the first company to successfully challenge Pfizer's Lipitor patent, it has the sole right to compete with brand-name Lipitor and Watson's authorized generic for the first 180 days after the patent ends.
But Teva and at least two additional companies are expected to sell their own generic Lipitor starting on June 1. Then the price for all the generics should plummet to about 20 percent of Lipitor's current price, about $115 to $160 per month, depending on dosage.
But Ranbaxy's manufacturing issues and an unprecedented scheme by Lipitor's maker, Pfizer Inc., upended what normally happens when a blockbuster drug's patent expires.
Amid repeated inquiries from journalists and others about the pending approval, Ranbaxy refused to comment. The FDA, per its standard procedure, stayed quiet until the approval was official.
Ranbaxy now has permission to sell atorvastatin tablets in 10, 20, 40 and 80 milligram strengths, the same as for brand-name Lipitor.
Rumors had been floating over the past week that Ranbaxy was close to a financial settlement with the FDA that would include approval to sell generic Lipitor. The FDA has been under pressure because patients, insurers and consumer advocates wanted widespread generic competition on time.
"This medication is widely used by people who must manage their high cholesterol over time, so it is important to have affordable treatment options," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement. "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 drugs, including two older generic cholesterol drugs, because of poor quality in two Ranbaxy factories. The FDA said that it had found problems that could result in contamination and allergic reactions, and that the company had not corrected them.
Meanwhile, Pfizer, which gets about one-sixth of its revenue from Lipitor, has started a strategy to retain as much revenue from Lipitor as possible, at least until next June. It is subsidizing both patients and insurers to keep their costs at or below generic prices — if patients stay on brand-name Lipitor for the next six months.
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, the drug lowers the risk for heart attack, stroke, chest pain and some types of heart surgery. It can also raise levels of good cholesterol.
In Pfizer's clinical tests of Lipitor, the most common side effects were nasal inflammation, joint pain, diarrhea and urinary-tract infections.