Teva Wins OK to Sell Zocor Copy

Teva Pharmaceutical Industries Ltd. won final regulatory clearance Friday to market its generic version of cholesterol medication Zocor after a federal judge threw out a motion from a rival company.

The 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 Food and Drug Administration 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 Friday. It generated $4.4 billion last year.

Sandoz, owned by Switzerland-based Novartis, 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 could win 180 days as the sole generic marketer of the 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. Often, the generic drug is priced at a 25% discount to the brand. That discount can fall to 90% 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 UnitedHealthcare 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 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 rule on this motion, which can be appealed, within 10 days.