Another US Generic To $3bn Ibrance Passes Muster – When Will They Launch?

List Of ANDA Filers Waiting In The Wings, After Generics Reached India

 
• By Dean Rudge
  
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A sizeable small-molecule opportunity, Pfizer’s Ibrance, is in the crosshairs for several major ANDA sponsors in the US, with Zydus the latest company to receive a tentative nod from the FDA.

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Zydus Lifesciences Limited has received tentative US Food and Drug Administration approval for its generic version of Pfizer’s Ibrance (palbociclib) tablets, teeing up the Indian firm to launch potentially its generic to the blockbuster treatment for HR-positive and HER2-negative breast cancer when a composition of matter patent expires later this decade.

Litigation remains ongoing between Pfizer and palbociclib abbreviated new drug application sponsors in US district courts, after ANDAs began reaching...

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