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FTC/Industry Showdown Over Orange Book Patent Listings Could Come In 2024

 
• By Brenda Sandburg

GlaxoSmithKline, Amneal and Kaleo delist patents on inhalers and autoinjectors in drug-device combination products in response to FTC criticism. But AstraZeneca, Boehringer Ingelheim, and Teva hold firm, teeing up legal battles if the Commission takes enforcement action.

ftc orange book patents
Battles over Orange Book patent listings seem likely as companies reject FTC claims of improper listings. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

The US Federal Trade Commission’s muscling into the arena of Orange Book patent listings could put pressure on the US Food and Drug Administration to finally issue guidance on whether sponsors can list drug delivery devices. It could also lead to litigation if the FTC takes enforcement action against companies that decline to delist patents the agency deems to be improperly listed.

In one of the most surprising actions of 2023, the FTC sent letters to eight drug manufacturers contending they had...

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