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Study Finds Limited Impact Of New FDA Rule On 30-Month Stays In Drug Patent Challenges

Law360 (February 26, 2004, 12:00 AM EST) -- Last year’s decision by the U.S. Food and Drug Administration to limit 30-month stays in pharmaceutical patent challenges isn’t likely to ease the pathway to the market for generic makers, according to a new study.

Only a small fraction of abbreviated new drug applications (ANDAs) with a paragraph IV certification have faced more than one 30-month stay anyway, the survey, by business intelligence firm Cutting Edge Information, concluded.

Generics drug applicants must include with ANDAs a statement addressing the generic drug's relationship to each Orange Book-listed...
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