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www.fdanews.com/articles/172434-pfizer-stops-otc-lipitor-program-in-us-following-trial-failure

Pfizer Stops OTC Lipitor Program in U.S. Following Trial Failure

August 4, 2015

Pfizer has terminated its over-the-counter Lipitor program in the U.S. after a Phase 3 clinical trial showed that patients required a physician’s help to take the cholesterol-lowering drug correctly.

The 1,311-patient study failed to show that patients would check their cholesterol levels as directed and take appropriate action based on those results. Pfizer announced the outcome last week.

The drugmaker has long banked on the prospect of an OTC version of Lipitor (atorvastatin calcium) to recoup flagging sales of its blockbuster drug, which lost patent protection in 2011. Last year, global sales were $2.1 billion — far below the $12.9 billion that Lipitor brought Prizer in 2006.

Still, analysts predict continued solid sales of Lipitor for years to come. “My forecast for Lipitor in 2020 is around $1.6 billion,” says S&P Capital IQ analyst Jeffrey Loo, adding that the majority of Lipitor sales are in emerging markets where branded established generics sell well. — Jonathon Shacat.