All Over But The Lawsuits? NCE Exclusivity For Fixed-Dose Combos Remains Prospective
This article was originally published in The Pink Sheet Daily
FDA rejects requests by firms to make new policy retroactive; Gilead’s Harvoni and Eisai’s Akynzeo fixed combos, approved the day FDA issued its final guidance, granted exclusivity.
You may also be interested in...
Citizen petition seeks five-year NCE exclusivity for Pfizer’s estrogen/bazedoxifene combo after district court tells FDA its inconsistent position is unreasonable.
Court finds FDA erred in not giving the fixed-dose combo product Prepopik five years of market exclusivity since it had awarded the exclusivity to similarly situated single-entity drug products.
Ferring requests five years of marketing exclusivity for Prepopik; Gilead also has asked FDA to award five years of exclusivity for active ingredients in a combination product that has not been previously approved, but Gilead has patents to fall back on while Ferring has none.