FDA announces five-year exclusivity for new chemical entities

The Food and Drug Administration (FDA) recently announced that fixed-combination drugs that are comprised of at least one new chemical entitity (NCE) will be eligible for five years of exclusivity.

The announcement came through a newly finalized guidance, “New Chemical Entity Exclusivity Determination for Certain Fixed-Combination Drug Products."

The FDA explained that they revised their interpretation of the term “drug” for the reason of exclusivity eligibility from “drug product” to “drug substance.” The five-year NCE exclusivity determination will apply to each drug substance in the product, rather than the drug product in its entirety. Through the FDA’s prior interpretation of the terms, fixed-combination drugs containing new chemical entities were only eligible for three years of exclusivity.

Five years of NCE exclusivity may produce more than five years of competition free marketing. The new guidance states, “If a drug product that contains a new chemical entity was approved ... in an application submitted under section 505(b) of the act, no person may submit a 505(b)(2) application or abbreviated new drug application under section 505(j) of the act for a drug product that contains the same active moiety as in the new chemical entity for a period of five years from the date of approval of the first approved new drug application.”