Best practices for Orange Book listings

21 November 2023

This week's Expert View comes from Jonathan Roses, a patent attorney at Boston, USA-based law firm Wolf Greenfield. In the context of an ever-evolving regulatory landscape, Mr Roses provides insights into how to successfully navigate the complexities of the US Food and Drug Administration's all-important "Orange Book."

In 1984, Congress passed and the President signed into law the Drug Price Competition and Patent Term Restoration Act, better known as the Hatch-Waxman Act.

As part of its creation of the modern generic drug, patent term restoration, and regulatory exclusivity schemes, Hatch-Waxman created the Orange Book to enable potential sponsors of new generic drugs to assess which patents might be asserted against them if they were to receive approval for and market a proposed generic product.

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