Predictive Analysis for First Submission of Generic Drug Application for Orphan Drug Products Using Random Survival Forest.

ABSTRACT: Rare diseases affect a small population of patients, resulting in low incentives for developing orphan drug products (ODPs). The United States Congress passed the Orphan Drug Act of 1983 to incentivize pharmaceutical manufacturers to develop drugs to treat rare diseases. However, ODPs generally have higher treatment costs than non-ODP treatments. Developing generic ODPs can benefit patients by increasing market competition and providing alternate treatment options. This research aims to identify factors influencing the first submission of abbreviated new drug applications (ANDAs) for generic orphan drugs. Data were collected from the U.S. Food and Drug Administration (FDA) databases (including but not limited to the FDA Orphan Drug Designations and Approvals database, Orange Book, and the

SUBMITTER: Hopefl R 

PROVIDER: S-EPMC12497357 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature