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FDA's Orange Book and ANDAs: Questioning the Policies and Precedents--and Recent Enforcement Actions--Surrounding RLD Patent Listings (2024 Update)

Karst KR.

Respiratory Drug Delivery 2024. Volume 1, 2024: 73-81.

Abstract:

The US Food and Drug Administration’s (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the ‘Orange Book,’ is as controversial today as it was when it came into existence in 1979. In fact, in recent years, controversy has been building, particularly concerning the listing of patent information for combination products, such as inhaled products. The 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 Orange Book. This article provides an overview of the Orange Book (including FDA’s 2020 notice as to patent information listings for inhaled drug products and other combination products), 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 have faced under the Federal Food, Drug, and Cosmetic Act (FDC Act) – and more recently, in late 2023 and early 2024, with the Federal Trade Commission (FTC), who are seeking to achieve broader competition among substitutable inhaled drug products.