Eon Generic Sporanox Approved; Launch Will Await Ruling In Litigation With Janssen
This article was originally published in The Pink Sheet Daily
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.
You may also be interested in...
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.
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.