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ANDA 180-Day "Triggering Period" Favored By FTC, Opposed By Industry

This article was originally published in The Tan Sheet

Executive Summary

FDA's proposed implementation of a 180-day "triggering period" for ANDA exclusivity is supported in comments submitted by the Federal Trade Commission, but opposed by Bristol-Myers Squibb, the Pharmaceutical Research & Manufacturers of America and the Generic Pharmaceutical Industry Association.

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Exclusivity ruling

A firm's 180 days of Waxman/Hatch marketing exclusivity begins with the first court ruling on the invalidity of a patent, not the final appeal decision, Washington, D.C. federal court Judge Richard Roberts rules in Mylan v. Shalala. FDA's current interpretation specifies 180-day exclusivity begins after the ruling of a court "from which no appeal can or has been taken." Roberts finds FDA's stance inconsistent with the language of the Waxman/Hatch Act, stating the statute's reference to "a court" includes a district court. FDA is reviewing the opinion and may not appeal it, although it would supersede a recent proposed rule on 180-day exclusivity trigger periods (1"The Tan Sheet" Nov. 22, 1999, p. 8)

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180-Day Exclusivity Must Begin Within 180-Day "Triggering Period" - FDA

Generic drug firms eligible for 180 days of marketing exclusivity would lose their eligibility if the exclusivity period were not triggered within 180 days of tentative approval of another ANDA referencing the same listed drug. FDA spells out this condition in an Aug. 6 proposed rule.

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