Court orders Teva patents to be delisted from Orange Book

12 June 2024
teva-logo-big

A New Jersey, USA, federal judge has ruled that five patents covering Israel-based Teva Pharmaceutical Industries (NYSE: TEVA)-brand asthma inhalers were improperly listed in the Food and Drug Administration’s (FDA) Orange Book, in a win for US drugmaker Amneal Pharmaceuticals (NYSE: AMRX).

This decision comes on the heels of the FTC’s targeting of Orange Book patent listings, which began last fall when the Federal Trade Commission (FTC) issued a policy statement cautioning drug manufacturers against listing noncompliant dug patents in the Orange Book. The FTC followed this up by challenging over 100 patents related to asthma treatments held by 10 major pharmaceutical companies. If a patent is listed in the Orange Book, branded drugmakers can sue under patent law to stop the sale of rival generics.

Expert assessment

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Today's issue

Company Spotlight





More Features in Generics