Generics Bulletin is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

UsernamePublicRestriction

‘Imminent’ Gilenya ANDA Launches Halted By US Supreme Court

Favorable Federal Circuit Ruling Is Overturned By Highest Federal Court

Executive Summary

In a dramatic twist, Gilenya ANDA sponsors are now unable to launch their generic products in the US after the US Supreme Court intervened in favor of originator Novartis, superseding the US Federal Circuit.

You may also be interested in...



ANDA Sponsors Silent As Novartis Confirms US Gilenya Generic Entries

One of the largest small molecule opportunities in the US, Novartis’s Gilenya to treat relapsing-remitting multiple sclerosis, now has generic competition, the originator has confirmed following a series of favorable court rulings for ANDA sponsors.

Victory Swings Back To Gilenya Generics With Latest US Supreme Court Order

Novartis, which reportedly generates $3.8m per day in US Gilenya sales, is once again facing up to the prospect of imminent generic competition to its blockbuster treatment for relapsing-remitting multiple sclerosis, following the latest order by the US Supreme Court.

Gilenya Generics May Be Imminent Amid US Federal Circuit Snub

Are US Gilenya generics set to flood the US market? HEC Pharm is hoping so, following a favorable Federal Circuit denial. However, in a bid to maintain its monopoly and avoid a potential $300m hit to its top line, Novartis is taking its fight to the US Supreme Court.

Topics

Latest News
See All
UsernamePublicRestriction

Register

GB152196

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

Cancel