Orange Book: Drug Products with Therapeutic Equivalence Evaluations

Generic Product Selection/Substitution

  • Definition of Generic Product: A generic product is a medication that has the same active ingredients, dosage form, strength, route of administration, and intended use as its branded counterpart; however, it may differ in appearance, packaging, and inactive ingredients.

  • Brand Name vs. Generic Name:

    • Brand Name (Trade Name): The name given by the pharmaceutical manufacturer for marketing; e.g., Prozac® for fluoxetine. Only the company can use the brand name.
    • Generic Name: The chemical name assigned to the drug; e.g., fluoxetine hydrochloride.
Types of Drug Product Equivalence

  • Overview: The FDA has established criteria to evaluate and list drugs that meet equivalency standards, leading to the creation of the Orange Book.

  • Approved Drug Products with Therapeutic Equivalence Evaluations:

    • Commonly referred to as the Orange Book.
    • Contains a list of multi-source drug products (more than one manufacturer).
    • Evaluated based on scientific data and judgment, to provide guidance but not mandates for prescriptions or dispensations.
    • Lists are advisory and do not dictate which products to select or avoid.
Therapeutic Equivalence Codes
  • Two-Letter Coding System: Determines if a product is interchangeable.
    • First Letter:
    • A: Therapeutically equivalent
    • B: Not therapeutically equivalent
    • Second Letter (for A's):
    • AA: Conventional forms without bioequivalence issues
    • AB: Products proven through studies to be bioequivalent
    • AN: Solutions/powders for aerosolization
    • AO: Injectable oil solutions
    • AP: Injectable aqueous solutions
    • AT: Topicals (includes various local delivery forms, e.g., creams, ointments)
Reasons for B Codes
  1. Known Bioavailability Issues: Active drug or dosage form identified as having problems which were not adequately studied.
  2. Quality Standards: Insufficient standards prevent determination of equivalency.
  3. Regulatory Review Status: If still under review, may be assigned a B code.
  • Examples of B Codes:
    • BC: Extended-release forms that require extensive studies
    • BD: New products with known bioavailability issues or no equivalency data
    • BE: Delayed-release forms dependent on dissolution
    • BN: Aerosol-nebulizer delivery issues
    • BP: Active drugs with potential bioavailability problems
    • BX: Insufficient equivalency data provided
    • B*: Products under re-evaluation due to new information.