Which term describes a drug produced by the brand manufacturer's company and marketed at generic prices during and after the 180-day exclusivity period that is identical to the brand product in active and inactive ingredients?

• A. Authorized Generic
• B. Therapeutic Generic
• C. Biosimilar
• D. Pharmacoequivalent

Answer: (A)

Authorized generic describes a version of a brand-name drug that is produced by the brand’s own company (or under its control) and marketed at generic prices. It is intended to be identical to the brand product in both active and inactive ingredients, and it can be sold during and after the 180-day generic exclusivity period. This arrangement allows the brand to compete like a generic while leveraging their own formulation.

This differs from a therapeutic generic, which focuses on achieving the same therapeutic effect but not necessarily identical inactive ingredients or production source. A biosimilar applies to biologic products rather than small-molecule drugs. Pharmacoequivalent is a broader term for products that are equivalent in active ingredient and strength but doesn’t specify that the drug is produced by the brand and marketed as a generic.