NEW YORK (AFX) - Consumers will soon have access to cheaper versions of the popular cholesterol medicine Zocor as federal regulators approved products for sale from two companies after a federal judge threw out a motion from a rival drug maker.
Teva Pharmaceuticals Industries Inc., an Israeli company, has already started shipping its versions of the four different dose strengths it has been approved to sell. Indian drug maker Ranbaxy Laboratories Ltd. won approval to sell the highest dosage of the pill, which isn't commonly prescribed.
Judge Royce C. Lamberth of the U.S. District Court for the District of Columbia denied a motion for a temporary restraining order filed by another generic manufacturer, Sandoz Inc., to block the FDA from approving generic forms of Zocor made by Teva or Ranbaxy. The denial of the motion cannot be appealed.
Merck & Co.'s Zocor lost patent protection on Friday. It generated $4.4 billion last year and Merck has forecast sales of $2.3 billion to $2.6 billion in 2006.
In a statement, Sandoz, owned by Switzerland-based Novartis AG, said it was disappointed in the ruling.
Teva said it had been granted 180 days of market exclusivity. Under federal law, the first generic company to file a patent challenge against the brand name manufacturer can win 180 days as the sole generic marketer of drug.
Sandoz sought the restraining order because, it said, Teva and Ranbaxy had unfairly received exclusivity.
The bulk of a generic company's profit on a product comes during the 180-day exclusivity period because the lack of competition means it doesn't have to slash prices deeply. Often, they only price at a 25 percent discount to the brand. That discount can fall to 90 percent once numerous competitors enter a market.
Managed care companies have been aggressively promoting the use of generic Zocor in their efforts to lower drug costs. Typically, sales of the brand name shrivel as generic competition enters the market but Merck has been trying to salvage some of its market share. It cut Zocor's price so low that UnitedHealth Care Group Inc. customers will pay less for the brand than for the generic.
Merck also granted a license to Indian manufacturer Dr. Reddy's Laboratories Ltd. to sell a generic version of Zocor.
Novartis filed another motion on Thursday that would block Teva and Ranbaxy from selling the drug. The companies have five days to file opposition to the motion. Lamberth is expected to make a ruling on this motion, which can be appealed, within 10 days.
Meanwhile, the FDA is appealing a federal judge's ruling that bestowed exclusivity on Teva and Ranbaxy. The appeal is expected to be heard sometime this summer, and the outcome could affect how soon other companies are allowed to sell generic Zocor.
U.S.-traded shares of Teva rose 94 cents, or 3 percent, to close at $32.19 Friday on the Nasdaq Stock Market at above average volume. Dr. Reddy's shares added 60 cents, or more than 2 percent, to close at $27.53 on the New York Stock Exchange, while those of Novartis climbed 34 cents, or nearly 1 percent, to close at $52.63.
http://www.fda.gov
http://www.novartis.com
http://www.tevapharm.com
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