Generic/Pediatric Exclusivity Overlap Not Required By Court Rulings - Hatch
Executive Summary
Recent court rulings regarding the triggering of generic exclusivity do not require that the exclusivity runs concurrently with a brand name company's pediatric exclusivity, Senate Judiciary Committee Chairman Hatch (Utah) maintains.
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Barr Fluoxetine Will Have Two Months Exclusivity Under "Worst Case"
Barr believes that in a worst case scenario it will still have two months of Waxman/Hatch exclusivity for its generic version of Prozac (fluoxetine).
Barr Fluoxetine Will Have Two Months Exclusivity Under "Worst Case"
Barr believes that in a worst case scenario it will still have two months of Waxman/Hatch exclusivity for its generic version of Prozac (fluoxetine).
Barr fluoxetine 180-day exclusivity
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