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Trapped by orphan drug rules, FDA blocks generic Treanda for 3 extra years

February 26, 2019 / Angus Liu

Once again, the FDA’s own regulations designed to foster rare disease drug development have forced the agency to extend the monopoly on an old drug. In what Bernstein analyst Ronny Gal called an “illogical decision” that will cost the public $3 billion, the FDA granted Eagle Pharmaceuticals’ blood cancer drug Treanda three more years of exclusivity, blocking generics until December 2022. The decision stemmed from Eagle's court victory granting orphan drug exclusivity—not to Treanda—but to its newer counterpart, Benedek, which shares the same active ingredient. 
How did such a bizarre situation happen? Basically, the FDA’s own regulations happened. Benedek got seven years of orphan drug exclusivity by court order. But a quirk in the FDA's own rules deems Benedek and Treanda as essentially the “same drug” because the newer drug hasn’t proven superior in the clinic. Therefore, exclusivity for Benedek applies t...