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FDA's Orange Book and ANDAs: Questioning the Policies and Precedents Surrounding RLD Patent Listings

Karst KR.

RDD Europe 2015. Volume 1, 2015: 59-66.

Abstract:

Food and Drug Administration (FDA)’s ability to approve Abbreviated New Drug Applications (ANDAs) for generic versions of topically active inhaled drug products, and generic drug manufacturers’ ability to successfully market such drug products as interchangeable with and substitutable for a brand-name Reference Listed Drug (RLD), not only raises complex scientific issues, but also difficult and novel legal issues implicating both food and drug law and patent law. These scientific and legal issues converge in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book). This article provides an overview of the Orange Book, an understanding of which is critical to appreciating drug product substitution in the US, and then describes a couple of the legal challenges FDA and industry face under the Federal Food, Drug, and Cosmetic Act (FDC Act) when seeking to achieve broader competition among substitutable inhaled drug products.