Barr Fluoxetine Generic Exclusivity Claim Faces Hurdles
Executive Summary
Barr's claim to 180 days of generic exclusivity for fluoxetine will depend on the outcome of judicial and regulatory proceedings over the next year.
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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, FDA In Discussions On Trigger For Generic Prozac Exclusivity
Barr's 180 days of Waxman/Hatch exclusivity for generic fluoxetine could depend on FDA's determination of whether a brand name company's pediatric exclusivity supercedes generic exclusivity, Barr told analysts during its quarterly conference call Oct. 24.