Anglo-Swedish drug major AstraZeneca has filed a law suit in the US District Court for the District of New Jersey against Apotex, seeking a declaration of patent infringement. On March 30, the US Food and Drug Administration granted approval for a generic version of AstraZeneca's Pulmicort Respules (budesonide inhalation suspension) to Apotex. The suit follows Apotex' indication of intent to market a generic version of the product in the USA prior to the expiration of the UK-based firm's patents.
Additionally, AstraZeneca has filed a motion for interim relief seeking to prohibit sales of Apotex' generic product until the patent infringement case has concluded. The Court has indicated that it will hear oral arguments regarding the motion on April 16.
AstraZeneca says it has full confidence in the strength of its intellectual property rights protecting the drug and will continue to vigorously defend and enforce these. Patents covering Pulmicort Respules expire in 2018 with pediatric exclusivity extending to 2019, the firm maintains.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2025 | Headless Content Management with Blaze