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

Hikma’s Vascepa Generic Approved But Launch Still A Mystery

Follows Favorable US District Court Ruling In March

Executive Summary

Hikma has eyes on launching a generic of Amarin’s Vascepa in the US following FDA approval and a favorable patent ruling at the district level in March. However, with a swift appeal filed by the originator in the works, the Jordanian firm is yet to pull the trigger.

You may also be interested in...



‘Swift’ Vascepa Victory Puts Hikma And Reddy’s In Pole Position

Hikma and Dr Reddy’s Laboratories are weighing launches of their generics to Amarin’s Vascepa after the US Court of Appeals for the Federal Circuit upheld a favorable lower court ruling. The originator said it would take its appeal to the next level and continued to raise doubts over supply capacity.

Hikma’s First-Half Profits Leap By A Quarter

Hikma has seen its reported operating profit jump by a quarter in the first half of 2020, as a lift from its injectables business helped to drive up turnover by almost a tenth.

Amarin Makes Vascepa Generics Prediction And Questions Supply

Amarin – and the industry at large – was stunned in March this year when Hikma and Dr Reddy’s walked away from court with an invalidity ruling against six Vascepa patents in the US. The originator’s CEO gave an impassioned update on the current state of play, including the potential for generics to launch ahead of a Federal Circuit ruling later this year or early in 2021.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

GB149922

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