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Barr fluoxetine 180-day exclusivity

Executive Summary

An overlap between Barr's generic exclusivity and Lilly's pediatric exclusivity periods for generic versions of Lilly's Prozac is possible, former generic industry attorney Alfred Engelberg says in Jan. 11 follow-up letter to FDA. Sen. Hatch (R-Utah) has written FDA twice maintaining the exclusivities should run consecutively (1"The Pink Sheet" Jan. 1, p. 10). Hatch is "actually claiming that the grant of pediatric exclusivity as to one patent tolls the running of generic exclusivity with respect to a second patent," Engelberg argued. "The truth is that Barr's predicament does not stem from any provision of FDAMA but rather results from the timing of" the court decision invalidating Lilly's first Prozac patent
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PS037170

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