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

Amarin Raises Supply Issue Again On US Vascepa Generics

Originator Eschews 2021 Guidance Following Hikma Launch

Executive Summary

With Hikma having launched the first generic version of Vascepa (icosapent ethyl) in the US last year, Amarin has again raised the issue of ANDA product supply for the complex purified fish oil brand.

You may also be interested in...



Hikma Stands Firm On Supply As It Scoffs At Latest Amarin Lawsuit

Hikma addressed supply concerns and the latest legal worries for its generic Vascepa product, as well as the recent launch of its long-awaited Advair generic, as management faced the virtual J.P. Morgan Healthcare Conference.

Hikma’s Vascepa Launch Strategy ‘Can Cause Market Confusion’

Issues over supply and the use of a skinny label have the potential to take a toll on the market for the fish oil drug icosapent ethyl, one analyst has claimed in the wake of Hikma’s recent generic launch.

Latest Vascepa Lawsuit Plunges Hikma Into Induced Infringement Battle

Hikma has pushed back against a further attempt by Amarin to counter its US generic version of Vascepa, this time via a fresh lawsuit claiming that the generic induces infringement of patents protecting cardiovascular indications for which the brand is approved but which are carved out of the generic label.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

ID004339

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