FTC Set To Take Enforcement Action Against Drugmakers Over Orange Book Patent Listings

Merger reviews could take into account sponsor's Orange Book behavior. FTC's statement does not detail what would make a patent listing 'improper' but the precedents from court cases against various sponsors should offer industry some guideposts.

Orange Book
FTC targets improper patent listings in FDA's Orange Book • Source: Shutterstock

The US Federal Trade Commission may take legal action against brandname drug manufacturers who improperly list patents in the US Food and Drug Administration’s Orange Book and factor this behavior in merger reviews. 

At their 14 September meeting, the three FTC Commissioners voted unanimously to adopt a policy statement that the agency...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Generics

Generics Bulletin’s Top 50 Ranking For 2025

 
• By 

This article compiles all of the data from Generics Bulletin’s 2025 ranking of the Top 50 firms across the generics and biosimilars industry, including additional details of how the various financial figures stack up.

The Generics Bulletin Top 50, Part Three: New Firms Enter Global Grouping

 
• By 

In the third instalment of this year’s Generics Bulletin Top 50, we reveal which firms have entered the ranking for the first time.

Latest EMA Biosimilar Nods Come For Henlius, Alteogen And Biocon

 
• By 

Denosumab, aflibercept and ustekinumab biosimilars received positive opinions from the EMA’s CHMP at its meeting in July, along with an Opsumit generic from Accord.

The Generics Bulletin Top 50, Part Two: Leading Players Leapfrog The Competition

 
• By 

In the second instalment of Generics Bulletin’s Top 50 ranking for 2025, we see plenty of movement among our mid-table collection of companies.

More from Products

The Generics Bulletin Top 50, Part Two: Leading Players Leapfrog The Competition

 
• By 

In the second instalment of Generics Bulletin’s Top 50 ranking for 2025, we see plenty of movement among our mid-table collection of companies.

Gateway To Africa: Natco Bids For 35.75% Of Adcock Ingram

 

Natco to buy out Adcock Ingram’s minority shareholders in what’s possibly its biggest M&A investment, opening up substantial opportunities in South Africa and the region. If the offer goes through, it will result in the delisting of Adcock, with Bidvest and Natco co-owning the firm.

The Generics Bulletin Top 50, Part One: German Giants Rise Up The Ranks

 
• By 

Two leading German generics and biosimilars giants were the big movers in our top ten ranking of off-patent industry leaders for 2025. We reveal the latest developments among the top players in the first instalment of this year’s Generics Bulletin Top 50.