The clock has been ticking for Pfizer’s blockbuster cholesterol pill Lipitor (atorvastatin) patent to expire, and now that time has come. Just as the patent expired, a generic version of the drug was approved by the FDA.
Ranbaxy Laboratories gained FDA approval Nov. 30 to develop generic atorvastatin calcium tablets in 10 mg, 20 mg, 40 mg and 80 mg doses. According to the FDA, the pills will be manufactured by New Brunswick, N.J.-based Ohm Laboratories.
“This medication is widely used by people who must manage their high cholesterol over time, so it is important to have affordable treatment options,” Janet Woodcock, MD, 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.”
Atorvastatin, a statin, works to lower cholesterol by blocking enzymes in the liver and is indicated for use along with a low-fat diet.
With the patent expiry, Pfizer may take a large blow with the potential loss of Lipitor sales that exceeded $10 billion annually; however, Pfizer isn't out of the ring yet. In August, the pharmaceutical company announced that it was looking to introduce an over-the-counter version of Lipitor that could be purchased without a prescription.
No word on whether the plan will go through, but the FDA has previously scrapped the idea of allowing over-the-counter cholesterol drugs such as Merck’s lovastatin. Pfizer said the plan would help retain revenues for the drug after the patent expired. While the brand name Lipitor sold for $4 to $5 per pill, generic versions will sell for less.