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Pravachol Exclusivity Case Remanded To FDA By Appeals Court

This article was originally published in The Tan Sheet

Executive Summary

FDA needs to develop policy clarifying how the voluntary dismissal of a patent litigation proceeding impacts a generic drug maker's 180-day exclusivity period, according to a D.C. federal appeals court decision issued March 16

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Generic Pravachol

FDA approval of Teva's generic pravastatin 10 mg, 20 mg and 40 mg is expected when Bristol-Myers Squibb's Pravachol patent expires April 20, Teva announces April 12. FDA "has denied Apotex's request for an agency determination that 180-day exclusivity for pravastatin 10 mg, 20 mg and 40 mg has been triggered and run," the firm adds. Teva was the first to file an ANDA for pravastatin but said it would not market the generic version until Pravachol's patent expired. However, voluntary dismissal of a complaint by Apotex regarding the drug triggered Teva's 180-day exclusivity period, which then would have expired in February. The firm sued FDA, and a federal appeals court remanded the case to the agency in March (1"The Tan Sheet" March 20, 2006, p. 13). According to Teva, FDA says it "interprets the court decision trigger provision to require 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"...

Generic Pravachol

FDA approval of Teva's generic pravastatin 10 mg, 20 mg and 40 mg is expected when Bristol-Myers Squibb's Pravachol patent expires April 20, Teva announces April 12. FDA "has denied Apotex's request for an agency determination that 180-day exclusivity for pravastatin 10 mg, 20 mg and 40 mg has been triggered and run," the firm adds. Teva was the first to file an ANDA for pravastatin but said it would not market the generic version until Pravachol's patent expired. However, voluntary dismissal of a complaint by Apotex regarding the drug triggered Teva's 180-day exclusivity period, which then would have expired in February. The firm sued FDA, and a federal appeals court remanded the case to the agency in March (1"The Tan Sheet" March 20, 2006, p. 13). According to Teva, FDA says it "interprets the court decision trigger provision to require 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"...

Generic Pravachol

FDA approval of Teva's generic pravastatin 10 mg, 20 mg and 40 mg is expected when Bristol-Myers Squibb's Pravachol patent expires April 20, Teva announces April 12. FDA "has denied Apotex's request for an agency determination that 180-day exclusivity for pravastatin 10 mg, 20 mg and 40 mg has been triggered and run," the firm adds. Teva was the first to file an ANDA for pravastatin but said it would not market the generic version until Pravachol's patent expired. However, voluntary dismissal of a complaint by Apotex regarding the drug triggered Teva's 180-day exclusivity period, which then would have expired in February. The firm sued FDA, and a federal appeals court remanded the case to the agency in March (1"The Tan Sheet" March 20, 2006, p. 13). According to Teva, FDA says it "interprets the court decision trigger provision to require 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"...

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