The approvals posted on the Food and Drug Administration's Web site Wednesday are in addition to those granted Teva Pharmaceutical Industries Ltd. and Ranbaxy Laboratories Ltd. 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 percent, analysts said. Teva has been selling copies for 8 percent 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 drugmaker's profits. Lipitor prescriptions declined 6 percent in the fourth quarter as health plans encouraged patients to switch to generic copies of Zocor, Bear Stearns analyst John Boris said in a Dec. 21 research report.
"Lipitor total prescriptions could experience further weakening as generic Zocor pricing declines as the 180-day exclusivity period expires in late December," New York-based Boris said.
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 drugmakers. 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 Web site Drugstore.com. Pfizer's Lipitor costs $3.47 a pill on Drugstore.com. A 70 percent reduction would push the price of generic Zocor to $1.36.
Additional companies receiving FDA approval on Dec. 20 to sell the medication include Cobalt Pharmaceuticals of Ontario, Canada; Aurobindo Pharma Ltd. of Hyderabad, India; and Zydus Pharmaceuticals Inc., a unit of Ahmedabad, India-based Cadila Healthcare Ltd.
The others are the Sandoz unit of Basel, Switzerland-based Novartis AG; Dr. Reddy's Laboratories Ltd. of Hyderabad, India; and Perrigo Co. of Allegan, Michigan.
The FDA cleared the Ivax unit of Petah Tikva, Israel-based Teva and Gurgaon, India-based Ranbaxy to make additional doses of the drug.
Perrigo already has started shipping its products, said Arthur Shannon, a firm spokesman. The newly approved generics are pushing prices lower, said Shannon, who said he could not provide the price for his company's drug.
"Pricing is very competitive," Shannon said. "It's significantly off branded prices."
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