Which type of drugs are referred to as Orphan Drugs?

Orphan drugs are specifically defined as drugs intended to treat rare diseases or conditions that affect fewer than 200,000 individuals in the United States. These drugs are developed under the recognition that there is often limited financial incentive for manufacturers to create treatments for uncommon diseases, given that the costs of development may not be recouped through sales. Thus, the correct answer points to the nature of these drugs, which cater to a population that is often overlooked due to the smaller market size.

The Orphan Drug Act, established in 1983, aims to encourage the development of such drugs by providing various benefits to manufacturers, such as tax credits for clinical trials, and seven years of market exclusivity upon FDA approval. This framework signals the importance of fostering innovation for conditions that otherwise would not receive adequate attention or would be neglected by pharmaceutical companies focused on more prevalent diseases.

In contrast, the other options do not align with the established definition of orphan drugs. For instance, drugs that affect over 200,000 persons do not fall under this category, as they are typically for common conditions. Drugs that do not require FDA approval does not relate to the concept of orphan status, as regulatory approval is essential regardless of the intended market. Similarly, while some orphan drugs