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Pharmaceutical Industry › Delisting › Food and Drug Administration (FDA)

White & Case LLP

Three Drug Pricing Litigation Issues to Watch in the Second Half of 2024

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It has been a busy year for issues related to drug pricing, and with the election around the corner, litigation issues that have been developing over the last few years are likely to be a key focus for the second half of...more

A&O Shearman

New Jersey District Court Orders Delisting Of Teva Inhaler Patents From The Orange Book

A&O Shearman on

On June 10, 2024, Judge Stanley R. Chesler of the United States District Court for the District of New Jersey granted the Amneal defendants’ motion for partial judgment on their counterclaims in a Hatch-Waxman dispute, and...more

Axinn, Veltrop & Harkrider LLP

FTC Spoke, Kaleo and Impax Listened: Orange Book Patent Delistings Begin

Axinn, Veltrop & Harkrider LLP on

As discussed last month, the FTC sent letters to 10 pharmaceutical companies, asserting that their listing of over 100 patents in FDA’s Orange Book for a variety of products was improper. Shortly thereafter, the FTC began...more

Axinn, Veltrop & Harkrider LLP

No Voluntarily Delistings or Disputes in FDA's Orange Book Update

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FTC recently placed improper Orange Book patent listings squarely in its crosshairs. In its September 2023 policy statement, FTC announced that it would “scrutinize improper Orange Book listings” and “use its full legal...more

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