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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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• By Dave Wallace

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Big Top-Level Shifts At Sun: Ganorkar Is MD, Ex-Takeda Exec To Helm US Business

 
• By Anju Ghangurde

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Lupin Looks To Expand In China With Respiratory Alliance

 
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Outlook Launches Ophthalmic Bevacizumab In Germany And The UK

 
• By Urtė Fultinavičiūtė

Outlook Therapeutics has started to conquer European markets with its ophthalmic version of bevacizumab. Meanwhile, across the pond in the US, it awaits the FDA’s decision, again.

Welch Heads Up Par Ahead Of Planned Spin-Off After Endo-Mallinckrodt Merger

 
• By Dave Wallace

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• By Dean Rudge

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