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

ANDA Sponsors Silent As Novartis Confirms US Gilenya Generic Entries

Ten Generics Manufacturers Hold FDA-Approved Fingolimod ANDAs

Executive Summary

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.

You may also be interested in...



‘Imminent’ Gilenya ANDA Launches Halted By US Supreme Court

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.

US Federal Circuit Will Not Stand In Way Of Gilenya Generics

ANDA sponsors targeting Novartis’s Gilenya have been informed by the US Court of Appeals for the Federal Circuit that at an ‘at-risk’ launch is possible, after the originator’s latest petition to the court was denied as it seeks a ruling from the US Supreme Court.

Viatris Eyes Gilenya Generic Following ‘Unreliable’ Study Data

Viatris has bounced back from withdrawing its application for a generic version of Gilenya in the EU with a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

GB152254

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