To market a generic version of a brand drug after patent expiration, which application is required?

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

Answer: (B)

The main idea is that bringing a generic version to market after the original patent expires uses an Abbreviated New Drug Application. An ANDA is abbreviated because it doesn’t require new safety and efficacy trials. Instead, the generic manufacturer shows that the product is bioequivalent to the reference listed brand drug and that it has the same active ingredient, dosage form, strength, route of administration, and labeling. If bioequivalence is demonstrated and quality standards are met, approval is based on reliance on the brand drug’s data.

The other options aren’t the path for generics. A full New Drug Application is needed for a truly new drug entity, not a generic. An OTC Monograph is a regulatory route for certain nonprescription products, not for producing or approving a generic prescription drug. A DESI evaluation pertains to evaluating older drugs that didn’t go through modern preapproval processes and isn’t the mechanism used to approve a generic version of an already approved drug.

So, the appropriate filing to market a generic after patent expiration is an Abbreviated New Drug Application.