News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter

AstraZeneca PLC (AZN): U.S. Appeals Court Issues Temporary Injunction Against Hanmi Pharmaceutical, Co., Ltd's 505(b)2 NDA Esomeprazole Strontium

9/16/2013 7:11:50 AM

free biotech news Get the latest biotech news where you want it. Sign up for the free GenePool newsletter today!

AstraZeneca plc : US appeals court issues temporary injunction against Hanmi’s 505(b)2 NDA Esomeprazole Strontium

AstraZeneca today announced that the US Court of Appeals for the Federal Circuit has issued a temporary injunction against the US launch of Hanmi's 505(b)2 NDA Esomeprazole Strontium product.

In June 2013, AstraZeneca entered into an agreement with Hanmi Pharmaceutical and affiliates ("Hanmi") and Amneal Pharmaceuticals ("Amneal") to streamline litigation issues regarding Hanmi's proposed Esomeprazole Strontium 505(b)2 NDA product.

Under terms of the agreement, Amneal and Hanmi have conceded the validity and enforceability of AstraZeneca's US Patent Nos. 5,714,504 and 5,877,192 that protect Nexium. The US District Court for the District of New Jersey ("District Court") will enter a Consent Judgment.

In July 2013, AstraZeneca filed a Notice of Appeal in the US Court of Appeals for the Federal Circuit ("Federal Circuit") regarding critical aspects of the District Court's December 2012 construction. Among issues, AstraZeneca is seeking a reversal of claim construction.

On 6 August, Hanmi Pharmaceuticals received US FDA approval for Esomeprazole Strontium.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients

CONTACTS Media Enquiries

Esra Erkal-Paler +44 20 7604 8030 (UK/Global)

Vanessa Rhodes +44 20 7604 8037 (UK/Global)

Michele Meixell +1 302 885 2677 (US)

Jacob Lund +46 8 553 260 20 (Sweden)

Investor Enquiries

Ed Seage +1 302 886 4065 mob: +1 302 373 1361

Karl Hård +44 20 7604 8123 mob: +44 7789 654364

Colleen Proctor + 1 302 886 1842 mob: +1 302 357 4882

Anthony Brown +44 20 7604 8067 mob: +44 7585 404943

Jens Lindberg +44 20 7604 8414 mob: +44 7557 319729

Help employers find you! Check out all the jobs and post your resume.

Read at

comments powered by Disqus