What does “Orange Book approved” mean for therapeutic equivalence?
In the U.S., the FDA’s “Orange Book” lists approved drug products and assigns a therapeutic equivalence designation for each active ingredient, strength, dosage form, and route of administration. Those designations indicate whether a product is considered therapeutically equivalent to a listed reference product for purposes of generic substitution. [1]
How does FDA decide “therapeutic equivalence” on the Orange Book?
FDA’s therapeutic equivalence evaluation for generic products generally rests on whether the applicant can demonstrate that the generic is bioequivalent to the reference listed drug (RLD) and meets applicable approval requirements (for example, through an Abbreviated New Drug Application, when eligible). When the equivalence requirements are met, FDA lists the product in the Orange Book with an “A” therapeutic equivalence code (or another code depending on specific conditions). [1]
Where can you find the therapeutic equivalence evaluation on the Orange Book?
The Orange Book records therapeutic equivalence directly for each listed drug product, including the FDA-approved therapeutic equivalence (“TE”) code associated with that product. Users typically look by active ingredient and then review the TE code for each manufacturer/strength/product listing. [1]
Which Orange Book TE codes mean “therapeutically equivalent”?
The Orange Book provides therapeutic equivalence codes that reflect FDA’s assessment of whether a generic can be substituted for the RLD. The most common practical interpretation is that products with the “A” code are considered therapeutically equivalent to the RLD. Other codes may indicate differences that affect interchangeability or substitution decisions. [1]
What counts as an “Orange Book approved drug product”?
An Orange Book approved drug product is one that appears in FDA’s list of approved drug products with therapeutic equivalence evaluations. That includes both brand-name (listed) drugs and approved generics (submitted and listed under abbreviated pathways when applicable). [1]
What if a product is listed but has no generic therapeutic equivalence?
Some Orange Book entries may not have a therapeutically equivalent generic product listed, or they may carry TE codes that do not support interchangeability in the same way as “A”-designated products. In those cases, substitution and therapeutic interchange rely on the specific TE code and product-specific approval status shown in the Orange Book record. [1]
Can you use the Orange Book to match drugs for substitution or switching?
Yes. Clinicians, pharmacists, and payers commonly use the Orange Book listing to identify the reference listed drug (RLD), locate approved generics, and check each product’s therapeutic equivalence code before substitution or switching—because the Orange Book is the FDA’s official source for approved products and their TE evaluations. [1]
Source
- DrugPatentWatch.com, “FDA Orange Book Approved Drug Products With Therapeutic Equivalence Evaluations” (links to Orange Book information and related resources): https://www.drugpatentwatch.com/orange-book/