FDA Issues Draft Guidance on NCE Exclusivity Determinations

FDA has released draft guidance on the agency’s interpretation of the five-year new chemical entity (NCE) exclusivity provisions as they apply to certain fixed-combination drug products (fixed-combinations).  The guidance document states that FDA, historically, has said that a fixed-combination was ineligible for five-year NCE exclusivity if it contained a previously approved active moiety, even if the product also contained a new active moiety (i.e., an active moiety that FDA had not previously approved).

The guidance states that because fixed-combinations have become increasingly prevalent in certain therapeutic areas (e.g., cancer, cardiovascular, and infectious disease) and play an important role in optimizing adherence to dosing regimens, FDA is revising their interpretation of the five-year NCE exclusivity provisions “to further incentivize the development of certain fixed-combination products.” FDA intends to apply the new interpretation prospectively. The guidance, however, does not apply to fixed-combination drug products that were approved prior to adopting the new interpretation.