FDA Changes Its Policy On Exclusivity For Fixed-Combination Products
This article was originally published in The Pink Sheet Daily
Executive Summary
In response to citizen petitions from Gilead, Ferring and Bayer, FDA issued a draft guidance saying future fixed-combination products that include a previously approved active moiety will be eligible for five years of new chemical entity marketing exclusivity.
You may also be interested in...
Fixed Combinations Of ‘Old Antibiotic’ Plus New Moiety Eligible For NCE Exclusivity, US FDA Says
A 2008 law that limited exclusivity for certain antibiotics to three years does not apply to Allergan’s Avycaz, which combines an approved old antibiotic active moiety and a new active moiety, CDER exclusivity board concludes.
NME Exclusivity Petitions Expand; Ferring Request For Colon-Cleansing Combo Has Urgency
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.
Gilead Compares Stribild To Prezista In Seeking Exclusivity For Fixed Dose Combinations
Gilead requests five-year marketing exclusivity for two of the components in its HIV Quad treatment Stribild; citizen petition says award should not depend on whether a new active moiety is approved first as a single entity product or as part of a fixed-dose combination.