Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

The History Behind The Drug-Device Combos Targeted By FTC

Executive Summary

Of the 16 products whose Orange Book patent listings have been challenged by the FTC, six have no generic competitors and two faced first generic launches this year. A review of their patent and pricing battles shows the difficulties in developing generics for these complex drugs.

You may also be interested in...



FTC’s Salvos Against Biopharma To Reverberate Through 2024

The Federal Trade Commission broke new ground last year in its opposition to M&A transactions and challenge of Orange Book patent listings. The biopharma community is waiting to see if deals will face similar hurdles in 2024 and whether there will be legal battles if manufacturers of drug-device combination products decline to delist their patents. Researchers advocate that the FTC extend its inquiry to device patents on GLP-1 receptor agonists, including Wegovy and Ozempic.

FTC’s Rahul Rao On Why Agency Targeted Drug-Device Orange Book Patents

Deputy director of the Bureau of Competition notes in an interview that the FTC focused on older products it felt should have more generic competition in its letters to companies citing improper patent listings. He says it is clear which drug-device combo patents should not be listed.

US FDA’s New Generics Chief: We Need More Flexibility For Complex Products

Iilun Murphy said Hatch-Waxman was written with immediate-release oral drugs in mind, not the complex generics becoming more popular today. The agency is evaluating the issue.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS149412

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel