What is the Origin of Reference Listed Drug (RLD)?

This regulatory term originated with the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, which created the abbreviated new drug application (ANDA) process for generics. The RLD designation is formally published in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, colloquially known as the Orange Book. This system was designed to streamline generic approvals while maintaining public health standards.

What is the Mechanism of Reference Listed Drug (RLD)?

Generic drug manufacturers seeking an ANDA must demonstrate that their product is pharmaceutically equivalent to the RLD, meaning it contains the same active ingredient, dosage form, strength, and route of administration. Crucially, they must also prove bioequivalence, showing that the rate and extent of drug absorption into the body are the same as the RLD. The RLD thus functions as the essential comparative standard to ensure that a generic hormonal drug will produce the same clinical effect as the original.

Reference Listed Drug (RLD)

Meaning

The Reference Listed Drug, or RLD, is an FDA-approved drug product that is designated by the agency as the standard against which all generic drug applications must be compared for approval. The RLD is typically the original brand-name drug that has demonstrated safety and efficacy through comprehensive clinical trials. In the context of hormonal health, the RLD serves as the benchmark for establishing the bioequivalence and therapeutic equivalence of subsequent generic versions of the same hormonal compound.