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Eon Generic Sporanox Approved; Launch Will Await Ruling In Litigation With Janssen

This article was originally published in The Pink Sheet Daily

Executive Summary

Eon’s ANDA for itraconazole is approved with 180-day marketing exclusivity, but launch depends on the outcome of the patent case. A judge’s decision on infringement and the doctrine of equivalents is pending.

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Eon Sporanox Generic Cleared To Launch By Court

The company is reviewing a trial court’s ruling that it does not infringe a Janssen patent before deciding whether to launch. Eon says its 180-day exclusivity will not be triggered until commercial marketing or an appellate court decision.

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Pink Sheet reporters and editor discuss the influence of the emergency use authorization on FDA decisions, another twist in the march-in rights debate, and how CBER is not using the real-time oncology review program.

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