FDA Draft Guidance Proposes Change to Combination Product Exclusivity Policy


New market exclusivity opportunities emerge for pharmaceutical companies.

In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its exclusivity policy for fixed combination drug products. If implemented, the guidance would provide five years of market exclusivity, rather than three years, to fixed-combination drug products that include both new and previously approved active moieties. The change will have significant effects on life cycle management strategies, corporate partnering activities, and the science around fixed-combination products, breathing new life into the value of some old drugs.

Statutory Five-Year Exclusivity Provision -

Under the Federal Food, Drug, and Cosmetic Act (FFDCA), sponsors of certain drug products can receive periods of market exclusivity granted by FDA that are in addition to the patent protection the products might otherwise have. Market exclusivity is intended to encourage innovation by protecting the owners of new drug applications (NDAs) from competition for prescribed periods of time. During these periods of time, FDA is prevented from approving and, in some cases, receiving applications submitted under section 505(b)(2) of the FFDCA and abbreviated new drug applications (ANDAs) that refer to the approved drug substance.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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