Generics Bulletin 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

UsernamePublicRestriction
UsernamePublicRestriction

Mylan Triumphs In Tecfidera Patent Challenge

Biogen's Tecfidera Future Uncertain After Patent Challenge Loss To Mylan

Executive Summary

Following a district court decision invalidating the '514 patent for Tecfidera, Mylan says it looks forward to launching a generic after final FDA approval is granted, despite Biogen saying it will appeal the ruling. The ANDA has a November action date.

You may also be interested in...



Mylan Overcomes Biogen Bid For Tecfidera Injunction

Mylan is a step closer to realizing launch of a generic version of Biogen’s $3.3bn Tecfidera (dimethyl fumarate) multiple-sclerosis brand in the US after the originator was denied an injunction pending its appeal of an unfavorable patent decision at the district court level.

COVID-19 Hits Sales Of Biogen Biosimilars Portfolio

Biogen received a bump to biosimilar earnings in the first quarter of this year, but this reversed in Q2 with fewer new patients venturing out to begin treatment on its portfolio of chronic treatment options. Management addressed the numbers, as well as Mylan’s recent victory over its Tecfidera intellectual property in the US.

Mylan Blocked By US Tecfidera Injunction

Mylan is aiming to be a first mover on generic Tecfidera (dimethyl fumarate), a brand with $3.3bn of sales last year, after successfully invalidating a key US patent shielding the multiple-sclerosis treatment until 2028. However, Biogen has procured a temporary injunction for now, as it seeks to defend its position on appeal.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

SC031354

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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