FDA Draft Guidance Proposes Change to Combination Product Exclusivity Policy

March 2014

In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its exclusivity policy for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.

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