Reference listed drugs (RLDs) play an important role in the generic drug development process. These drugs are licensed and FDA listed, and are usually the originally produced drug that all generics, produced thereafter, have been compared to. In order for a generic drug to gain FDA approval, it will have to model the RLD in a number of ways;

  • Must contain the same main active ingredient as the RLD, although, inactive ingredients may vary
  • Must replicate the same strength, dosage form, quality, performance characteristics, route of administration, and intended use
  • Must be bioequivalent to the RLD
  • Must be manufactured under similar strict standards of FDA regulation required for the RLD

As such, procuring a RLD is a crucial factor in any generic drug development strategy. Without this reference information, it would be impossible for a company to complete the required Abbreviated New Drug Application (ANDA). This application contains the data that allows the FDA to review and either approve or disapprove a generic drug product. Once this ANDA is completed, and the drug is approved, the company will be able to manufacture and sell the generic as a cost-effective alternative to those already on the market. To avoid any ambiguity, and prevent the opportunity for brand counterfeit to occur, the FDA lists only one RLD for each brand name drug. As such, all companies manufacturing a generic drug alternative for the same brand name drug, have to use the same reference product to obtain their comparison data. The publication, Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book, provides a list of all the approved drugs, as well as the RLD that should be used for a specific generic drug development process.

Because generic drugs account for just under 70% of all dispensed prescriptions in the US, the generic drug market is an invaluable part of the country’s health system. For companies to participate in this market, they must understand the role that RLDs play, and be able to procure these drugs effectively and efficiently.