Alvogen And Natco Facing Decade Wait On Ibrutinib After US Appeal Fails
Delaware District Court Had Previously Rejected Four Patent Challenges
The US Court of Appeals rejected all arguments brought by Alvogen and Natco in their appeal against an unfavorable lower court Imbruvica (ibrutinib) ruling, leaving the ANDA sponsors facing a significant wait to potential approval and launch.
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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Natco says it will be entitled to 180-day exclusivity for four strengths of ibrutinib tablets in the US after receiving tentative FDA approval.
With its own interests in the branded eye-disease space, Regeneron has commented on ranibizumab biosimilar sponsor Biogen’s fortunes during a recent conference.