Which statement about TE codes is incorrect?

Which statement about TE codes is incorrect?

• A. TE codes are two-letter codes used to designate therapeutic equivalence
• B. The first letter of the TE code indicates therapeutic equivalence rating
• C. The second letter describes the dosage form or other special cases
• D. TE codes are used to designate marketing exclusivity

Answer: (D)

TE codes are two-letter designations that indicate therapeutic equivalence and guide substitution decisions. The first letter signals whether a product is therapeutically equivalent to the reference product (A means therapeutically equivalent; B means not therapeutically equivalent). The second letter describes dosage form or other formulation-specific details, such as salt form, route, or special characteristics that affect how the product is used. These codes come from the FDA’s system used in the Orange Book to help pharmacists know when a generic can be substituted for a brand-name product. The statement about TE codes designating marketing exclusivity isn’t accurate. Marketing exclusivity is a separate concept that protects data or market access for a period of time and isn’t conveyed by TE codes.

TE codes are two-letter designations that indicate therapeutic equivalence and guide substitution decisions. The first letter signals whether a product is therapeutically equivalent to the reference product (A means therapeutically equivalent; B means not therapeutically equivalent). The second letter describes dosage form or other formulation-specific details, such as salt form, route, or special characteristics that affect how the product is used. These codes come from the FDA’s system used in the Orange Book to help pharmacists know when a generic can be substituted for a brand-name product.

The statement about TE codes designating marketing exclusivity isn’t accurate. Marketing exclusivity is a separate concept that protects data or market access for a period of time and isn’t conveyed by TE codes.