The US Food and Drug Administration (FDA) has granted orphan drug exclusivity to Hyperion's Ravicti (glycerol phenylbutyrate) liquid.
Hyperion Therapeutics president and CEO Donald Santel said that the orphan drug exclusivity further strengthens the protections for Ravicti.
"Additionally, as we recently announced, we were issued a patent that relates to use of RAVICTI with optimal measurement timing and target levels for blood ammonia in urea cycle disorder (UCD) patients," Santel added.
"It has a term that expires in March 2032 and is now listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, known as the Orange Book."
The orphan exclusivity is for seven years from the date of the approval on 1 February2013.
RAVICTI is indicated for use as a nitrogen-binding agent for chronic management of adult and pediatric patients greater than or equal to two years of age with UCD that cannot be managed by dietary protein restriction and/or amino acid supplementation alone.
