FDA clears six more companies to sell generic Zocor

U.S. regulators cleared six more companies to sell generic copies of Merck & Co.’s cholesterol drug Zocor, signaling steeper price reductions.

The approvals posted on the Food and Drug Administration’s website Wednesday are in addition to those granted to Israel’s Teva Pharmaceutical Industries Ltd. and Ranbaxy Laboratories Ltd. of India in June, when Merck’s patents expired.

The new versions of the world’s second-best-selling cholesterol-lowering pill will drive prices down as much as 70%, analysts said. Teva has been selling copies for 8% less than Merck.

The price drop may hurt sales of Pfizer Inc.’s Lipitor, the world’s top-selling drug with revenue last year of $12.2 billion and the source of almost half of the New York-based drug maker’s profit. Lipitor prescriptions have fallen modestly as health plans encouraged patients to switch to generic copies of Zocor, Bear Stearns analyst John Boris wrote last week.

“Lipitor total prescriptions could experience further weakening as generic Zocor pricing declines as the 180-day exclusivity period expires in late December,” Boris said in a research report.

As the first companies to file for approval of Zocor copies, known as simvastatin, Teva and Ranbaxy won six months of exclusivity under a U.S. law designed to offer an incentive to generic drug makers. That enabled them to keep prices close to what Whitehouse Station, N.J.-based Merck charges.

Teva’s 20-milligram generic Zocor costs $4.16 a pill, compared with $4.53 for Merck’s version, according to the website drugstore.com. Pfizer’s Lipitor costs $3.47 a pill on drugstore .com. A 70% reduction would push the price of generic Zocor to $1.36.

The firms that received FDA approval Dec. 20 to sell the medication included Cobalt Pharmaceuticals of Canada, India’s Aurobindo Pharma Ltd. and Zydus Pharmaceuticals Inc., a unit of India-based Cadila Healthcare Ltd.

Also receiving approval were the Sandoz unit of Switzerland-based Novartis, Dr. Reddy’s Laboratories Ltd. of India and Perrigo Co. of Allegan, Mich.

Perrigo already has started shipping its products, said spokesman Arthur Shannon, who said he couldn’t provide the price for his company’s drug.