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Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act).
The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law that established the modern system of generic drug regulation in the United States.
The Orange Book: Reclaiming Liberalism, by members of the British Liberal Democrat party Approved Drug Products with Therapeutic Equivalence Evaluations , published by the FDA's Center for Drug Evaluation and Research
In January 2020, a panel of judges at the Court of Appeal for the Federal Circuit called into question the validity of the last remaining orange book patent protecting Gilenya. [36] In October 2022, the Supreme Court turned down a request by Novartis to block the launch of generic versions of Gilenya in the United States.
Joseph Fuisz eventually moved back to Fuisz LLC, concentrating on drug delivery patents. Joseph Fuisz is also a named inventor in the Orange Book for the drug, Suboxone.
Between 2010 and 2012, drugs that make up 42% of Pfizer's pharmaceutical revenue will lose patent protection, among them the antacid Protonix.
Orange-Book-Standard (Az. KZR 39/06) is a decision issued on May 6, 2009 by the Federal Court of Justice of Germany ( German: Bundesgerichtshof, BGH) on the interaction between patent law and technical standards, and more generally between intellectual property law and competition law.
Patent families may be visualized using graphical trees as PDF files. The Lens currently links to regulatory data in the form of the United States Food and Drug Administration (FDA) Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
In March 2012, the company filed a patent infringement lawsuit against three companies that had filed Abbreviated New Drug Applications with the US FDA, claiming infringement of Depomed's six US patents listed for Gralise in the FDA's Orange Book.
He provides U.S. Food and Drug Administration (FDA) regulatory advice relating to pharmaceuticals, including advice concerning patent term extensions under Section 156 and Orange Book patent listings. Barkoff is a regular speaker at pharmaceutical patent law conferences.