"New Chemical Entity Exclusivity Determinations for Fixed-Combination Drug Products": Combo Drugs Now Eligible For 5-Year Exclusivity

The Food and Drug Administration (FDA) recently finalized guidance which allows fixed-combination drugs consisting of at least one new drug product to be eligible for a five-year “New Chemical Entity” (NCE) exclusivity period. FDA’s policy, entitled New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products, changes the Agency's previous interpretation that rendered combination products with even one “previously approved moiety” ineligible for five-year exclusivity. While this policy is good news for manufacturers of combination products going forward, FDA’s new guidance does not apply retroactively. What Are Combination Drugs? Combination drugs are products that include two or more active pharmaceutical ingredients. Combination drugs may contain both new chemical entities and already approved chemical entities. For example, Gilead’s HIV treatment, Stribild, is a combination of four drugs combined into one pill (two previously approved active “moieties” and two that are new). As FDA notes, combination drugs have become the “standard of care” in the treatment of certain cancers, cardiovascular disease, and infectious disease because the simplified medication helps promote adherence by patients, and may improve treatment outcomes and reduce drug resistance. Exclusivity of Combination Drugs The FDA grants “exclusivity” to New Drug Application (NDA) applicants if certain statutory requirements are met. Exclusivity provides...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs