Teva: FDA denies Apotex's request for pravastatin exclusivity

By Lisa Kerner

Erie, Pa., April 12 - Teva Pharmaceutical Industries Ltd. said the Food and Drug Administration has denied Apotex's request for a determination that 180-day exclusivity for pravastatin 10 mg, 20 mg and 40 mg has been triggered.

Teva expects final approval with exclusivity on April 20, when the product patent expires, according to a company news release.

The FDA concluded that the trigger provision requires "a decision of a court that on its face evidences a holding on the merits of patent noninfringement, invalidity, or unenforceability." The July 23, 2004 Apotex-Bristol dismissal does not contain such a holding, the release stated.

Teva is a generic pharmaceutical company based in Israel.

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