Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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.

You may also be interested in...

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.

Pink Sheet Podcast: EUA’s Impact On US FDA, March-In Rights, CBER And Real-Time Oncology Review

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.





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts