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

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.

Seeking To Provide ‘The Best Clarity Possible,’ ACIP Votes For COVID Vaccine Booster In Children 5-11

CDC advisory committee recommends Pfizer/BioNTech vaccine booster, but one member votes ‘no,’ citing concern that only 29% of children ages 5 to 11 have received the primary two-dose series and arguing the focus should be on additional vaccinations, not additional doses.

US FDA Could Require Pediatric Cancer Drug Combo Studies Under Amended User Fee Bill

House Energy & Commerce Committee adds Give Kids a Chance Act to user fee reauthorization package during markup. Bill was modified to exclude provision giving the FDA authority to require preclinical studies.

Topics

Related Companies

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