RE: Surufatinib Orphan Drug status25 Nov 2019 08:11
Orphan Drug Designation offers the following incentives:
•
Waiver of the user fee (application fee) upon filing a marketing application (the 2016 fee for an application that includes clinical data is $2,374,200 and establishment fees are an additional $585,200)37;
•
Tax credits for clinical research undertaken by the sponsor to generate required data for market approval (deduct 50% of clinical trial costs)38;
•
Marketing exclusivity for an approved drug for 7 years after product approval39;
•
Protocol assistance from either CDER or CBER39; and
•
Financial assistance from the Office of Orphan Products Development (OOPD), which provides up to $250,000 per year for up to 3 years for phase 1 trials and up to $500,000 per year for up to 4 years for phase 2 and 3 trials.40