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

Trio Face 11 Year Wait On Eliquis As US Patents Upheld

Key Formulation Patent Stands Strong Against Attack From Three Firms

Executive Summary

Three ANDA sponsors – HEC’s Sunshine Lake, Sigmapharm and Unichem – for generic versions of Eliquis had elected to take their Hatch-Waxman case to trial but were soundly beaten by originator’s Bristol-Myers Squibb and Pfizer. A launch in 2031 could now be their best, and only, option.

You may also be interested in...



Stockwatch: Second-Quarter Earnings Highlight The Duracell Bunny PD-1 Inhibitor Race Winner

After the differing second-quarter financial performances of Roche, AstraZeneca and Pfizer’s oncology franchises, the reports by Merck & Co and BMS should have helped define the effects of the pandemic on oncology businesses.

First US Eliquis Generics Face Six-Year Wait

Mylan and Micro Labs have received the first FDA approvals for generic rivals to BMS’ Eliquis oral anticoagulant. However, as a result of the firms’ settlements with the originator, BMS does not expect the generics to hit the US market until 2026.

Teligent Announces $140m Operating Loss As Plant Woes Continue

Struggling Teligent underlined the importance of lifting the FDA Warning Letter against its key manufacturing facility in Buena, New Jersey, as its impact slammed the company’s operations last year.

Topics

Related Companies

UsernamePublicRestriction

Register

GB150146

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