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

Copaxone 40mg Generic At-Risk Launch Anticipated As Soon As February

Executive Summary

Teva is seeking injunction to block generic entry after court rules four patents on the three-times-a-week dosage are invalid; analysts expect launch soon after FDA approves an ANDA, with Sandoz/Momenta generic the likely leader.

You may also be interested in...



Fate Of Copaxone 40mg Patents Depends On Courts After PTAB Rejection

Teva awaits district court ruling on patents covering the three-times-a-week dosage and is appealing the Patent Trial & Appeal Board’s findings of unpatentability.

DOJ Enforcement: Talking With US FDA Is Not Enough To Get Credit For Self-Disclosure

Remediation of a problem with FDA is one factor the DOJ considers in assessing whether a company gets credit for self-disclosure of misconduct prior to a criminal investigation, but it wants companies to come directly to the department to divulge wrongdoing.

What Would US FDA Do If Supreme Court Eliminates Or Curtails Chevron Deference?

Lawyers say agency will have to bolster its administrative record as judges tackle complex policy and scientific issues previously left to FDA. Some cases, such as challenges to exclusivity decisions, may be reopened.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

GB002353

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