RLD: Paving the way for US generic drug approvals

Abstract

The availability of generic drugs is essential for giving patients access to cheap medications and corresponding reference listed drugs (RLDs) have a pivotal role in the authorization of these medicines, which acts as a standard for comparison. This article outlines the importance of RLDs in the authorization of generic drugs and meet requirements like bioequivalence studies, stability studies and proper labelling. It also looks at the challenges they face, such as limited access to RLD samples or strategies like pay for delay agreements, authorized generics, and product hopping. It also discusses laws like the Creates Act and Affordable Care Act, which aim to encourage fair competition. Finally, this article shows how generic drug launches can reduce prices and affect the sales of brand name drugs, using real world examples to highlight these effects.

Keywords

Bioequivalence Hatch-Waxman amendment Reference listed drug Suitability petitions ANDA Patent

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