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

 
• By Brenda Sandburg

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...

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• By Dean Rudge

Hikma is seeing increased US demand for its generic Victoza (liraglutide) after the end of semaglutide compounding lifted prices for Novo Nordisk’s Ozempic and Wegovy. Meanwhile, the company is not for now pursuing semaglutide generics in the US or EU due to patent protection, but is targeting MENA.

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Iron Sucrose Competition Expands With Viatris and Amphastar FDA Approvals

 
• By Dean Rudge

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Iron Sucrose Competition Expands With Viatris and Amphastar FDA Approvals

 
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The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.

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Amgen sees potential regulatory shifts toward streamlined biosimilar approvals as favorable, citing its strength in developing high-quality products.