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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...

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More from Generics

Swissmedic Slashes Months Off Review Time For Certain Drug Filings

 
• By Anabel Costa-Ferreira

Switzerland’s health care products agency said it had cut the time it takes to review marketing applications for certain drugs submitted via its regulatory reliance procedure because it wants to further enhance the appeal of the pathway.

US FDA Upheaval Forces User Fee Talks To Begin Later Than Usual

 
• By Derrick Gingery

The fall start of PDUFA and GDUFA negotiations could impact the agreement review process and other parts of the schedule intended to ensure it reaches Congress on time.

Vanda Slams US FDA ‘Generic Bias,’ Again Seeks To Undo Hetlioz ANDA Approvals

 
• By Dave Wallace

In its latest attempt to curtail generic versions of Hetlioz, Vanda Pharmaceuticals asked FDA Commissioner Martin Makary to reverse a previous agency decision upholding two ANDA approvals, claiming an “unacceptable culture of bias toward approving generic drugs” at the agency.

Generic Industry Looking For Expanded Inspections As US FDA Rehires Staff

 
• By Grace Moser

Generic drug industry representatives applauded the FDA decision to bring back key staff in the Office of Generic Drugs that were laid off earlier this year.

More from Biosimilars & Generics

Generic Industry Looking For Expanded Inspections As US FDA Rehires Staff

 
• By Grace Moser

Generic drug industry representatives applauded the FDA decision to bring back key staff in the Office of Generic Drugs that were laid off earlier this year.

US FDA Maintaining Approval Output Despite Losing Staff

 
• By Derrick Gingery

Reviewers were not targeted by the FDA reduction in force, but increasing attrition and difficulties hiring new staff still do not seem to have impacted new and generic drug approval totals.

Generic Drug Industry Seeks More US FDA Communication Reforms In GDUFA Renewal

 
• By Sue Sutter

Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.