FDA Issues New Guidelines on Exclusivity for Fixed Dose Combinations

October 2014

The US Food and Drug Administration “the FDA” has issued new guidelines for determining the eligibility of regulatory market exclusivity for fixed dose combinations. 

Under the new guidelines a fixed dose combination product will be entitled to 5 years of market exclusivity from the date of approval of the combination product provided that at least one of the active agents in the combination has not previously been approved by the FDA.

This is a significant departure from the previous position taken by the FDA, in which fixed dose combinations were not entitled to any regulatory exclusivity if any of the actives had been previously approved by the FDA.

The new guidelines represent an acknowledgement by the FDA of the importance of fixed dose combinations in optimising patient compliance and treatment response and will provide innovators with an incentive of 5 years exclusivity for qualifying combination products.  However, the new guidelines will not be applied retrospectively to fixed dose combination products which have already been approved by the FDA.

 A copy of the guidelines can be found here.

This update was prepared by Mike Nelson, Partner of our Leeds office.  Tel: +44(0) 113 233 0100.

If you would like further advice on this or any other matter, please contact Mike Nelson or your usual HGF representative or visit our Contact Page to get in touch with your nearest HGF office.