Trump's Budget Request To Include ANDA Exclusivity Changes
180-day exclusivity would begin when a second ANDA is approvable, rather than at first-generic's launch, a potentially major change to the Hatch-Waxman framework if implemented.
180-day exclusivity would begin when a second ANDA is approvable, rather than at first-generic's launch, a potentially major change to the Hatch-Waxman framework if implemented.