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Alvogen Imbruvica Ruling Set To Push AbbVie’s Monopoly To 2032

Icelandic Firm And Partner Natco Fail With Invalidity Challenges

 
• By Dean Rudge
  
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Alvotech and Natco have failed to persuade a US court that certain of AbbVie’s IP shielding its Imbruvica blockbuster is invalid. In response, the originator said that it did not anticipate generic competition to its branded oral therapy for treating forms of cancer until March 2032, assuming pediatric exclusivity is granted.

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Alvogen failed with several invalidity challenges • Source: Shutterstock

Alvogen, Inc. and partner Natco Pharma Limited have been handed a major setback in their attempt launch a generic version of AbbVie’s Imbruvica (ibrutinib) tablets ahead of patent expiry, with a US district court ruling that the Icelandic firm’s proposed abbreviated new drug application infringes certain of the originator’s patent claims and that patent claims are not invalid.

Following the decision, which was handed down by a Delaware district court, and considering “several settlement and license agreements with...

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