Judge Overturns Ruling, Says FDA Must Grant Ferring’s Prepopik Exclusivity
A federal judge rescinded his own verdict backing the FDA’s decision to not grant Ferring exclusivity for its bowel preparation drug Preponik, ruling that the agency must give the company five-years of retroactive exclusivity.
U.S. District Judge Rudolph Contreras reversed his decision after Ferring showed instances in which the FDA’s previous interpretations of the Hatch-Waxman amendments, which give certain drugs five-year marketing exclusivity, failed to treat “similar cases in a similar manner.”
In his ruling, Contreras cites Gilead as example. Gilead submitted an NDA for a combination product that contained two approved and two unapproved active ingredients.