FDA recently announced that Fixed-Combination Drugs (FCD) comprised of at least one NCE will be eligible for 5 years of exclusivity.  FDA explained that it has revised its interpretation of the term “drug” for the purpose of exclusivity eligibility from “drug product” to “drug substance”. Therefore, the 5-year NCE exclusivity determination will apply to each drug substance in the product, not the drug product as a whole. FDA’s previous interpretation of the terms meant that FCDs containing NCEs were only eligible for 3 years of exclusivity.  The announcement came in the form of a newly Finalized Guidance entitled New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products. To view the Guidance, click here.
The 5-year NCE Competitive Advantage
While 3-year exclusivity bars approvals of the same drug products until expiry, 5-year exclusivity may bar 505(b)(2) and generally bars ANDA submissions until expiry. The obvious de facto effect is that 5 years of NCE exclusivity may yield greater than 5 years of competition-free marketing. According to the regulations as cited in the Guidance “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 5 years from the date of approval of the first approved new drug application”. On the other hand, the new guidance also includes a description of FDA’s “Umbrella Policy” under which FDA has allowed certain drug products subsequently developed that contain the same active moiety to share the balance of the original product’s 5-year NCE exclusivity.
Combination Drug Development Could Yield a New Standard of Care
FDA noted in the new Guidance that combination therapy is emerging as the standard of care in certain disease settings including cancer, cardiovascular disease, and infectious disease. Further, FDA wishes to incentivize the development of certain fixed-combination products.   The key to success in combination drug development is the employment of strategic planning principles beginning at project conception. The engagement of a pharmaceutical consultant with experience in 505(b)(2) submissions should be addressed at the earliest stages of development.
Pharmaceutical Development Group, Inc. (PDG) is a global pharmaceutical consultant with extensive experience in the strategic development of 505(b)(2) drug products. From identification and choice of viable candidates through ensuring the existence of cost-effective commercialization strategies, PDG is unique in its ability to comprehensively and ideally integrate products, dosage forms, populations and FDA regulatory pathways. Please feel free to contact us for more information.
PDG Regulatory Expert is Vice-President of Operations and Business Development for PDG. The opinions and statements in this press release are solely those of PDG Regulatory Expert and do not necessarily reflect the views of PDG.