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KemPharm And The Curious Case Of Launching A Brand Opioid Like A Generic

 
• By Jessica Merrill

KemPharm is looking to sign a generic drug partner to launch its new brand opioid Apadaz, which says a lot about how the commercial promise of abuse-deterrent opioids has so far failed to materialize. 

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KemPharm Inc. is preparing to launch its first commercial drug, the new branded opioid Apadaz (benzhydrocodone/acetaminophen), but is looking to sign a generic drug partner to do it and to follow a generic drug model. The company's commercial pivot to selling Apadaz – an immediate-release opioid with abuse-deterrent properties – at an equivalent price as the existing generic says a lot about how the commercial promise of opioids with abuse-deterrent properties has failed to deliver and how commercializing a new opioid successfully may require out-of-the-box thinking.

The strategy to partner with a generic drug company for the launch is a bit of a last resort effort...

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US ‘Red Tape’ Bill Again Targets Biosimilar Interchangeability – Will It Succeed This Time?

 
• By Dave Wallace

After multiple past attempts, US legislators have once again proposed a bill that would make all biosimilars immediately interchangeable upon approval. Could a fresh political context help it to succeed this time?

AstraZeneca Agrees Last-Minute $50m Settlement In Seroquel XR Delay Case

 
• By Dean Rudge

A class action suit alleging AstraZeneca delayed generic competition for Seroquel XR by making illegal agreements that stifled market entry for generic quetiapine competitors has been dismissed after the originator agreed to settle for tens of millions of dollars.

Trump’s FTC Continues The Mission Of Eliminating Orange Book’s Improper Patent Listings

 
• By Urtė Fultinavičiūtė

In a somewhat surprising move, president Donald Trump’s Federal Trade Commission carries the torch in a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon told Generics Bulletin what it means for the generic drug industry.