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FDA’s Orange Book Dispute Resolution Process May Grow Teeth With FTC Patent Listing Challenges

 
• By Brenda Sandburg

People have challenged patent listings more than 60 times in the past six years but it is up to new drug application holders to decide whether to revise or delist their submissions.

Dispute book
FTC invokes new use of FDA process to challenge Orange Book patent listings • Source: Shutterstock

The US Federal Trade Commission put a spotlight on the US Food and Drug Administration’s process for disputing listings in its Orange Book when it claimed manufacturers of drug-device combination products improperly listed their patents. The FTC’s use of the process differs from that of others as its enforcement power could compel companies to actually delist.

The FTC sent notice letters to 10 companies objecting to patent listings for asthma and chronic obstructive pulmonary disease inhalers and epinephrine auto-injectors. The agency said it was utilizing FDA’s...

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More from Generics

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.

US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
• By Derrick Gingery

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.

Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By Dean Rudge

Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.

More from Biosimilars & Generics

US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
• By Derrick Gingery

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.

Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By Dean Rudge

Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.

US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 
• By Michael McCaughan

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.