If a brand-name drug's patent has expired and a manufacturer wants to produce a generic version, which filing is required?

• A. NDA
• B. Abbreviated NDA (ANDA)
• C. OTC Monograph
• D. DESI Evaluation

Answer: (B)

When a brand-name drug’s patent has expired and a company wants to offer a generic version, the filing used is an Abbreviated New Drug Application. The ANDA is designed so the generic can be approved without repeating full safety and efficacy trials; instead, it must demonstrate bioequivalence to the reference product and show that it uses the same active ingredient, strength, dosage form, and labeling. This path relies on the existing data for the brand-name drug, not on new clinical trials.

The other options don’t fit this scenario. A full New Drug Application is for bringing a completely new drug to market. An OTC Monograph applies to nonprescription products and their approved conditions, not to traditional prescription generics. DESI evaluations concern older drugs reviewed under historical efficacy standards and are not the standard route for approving a generic version.