AstraZeneca enters into agreement to resolve Faslodex patent litigation in the US

Regulatory News Service

13 July 2016 at 07:00

This announcement contains inside information

AstraZeneca today announced that it has entered into an agreement with Sandoz, Inc. and affiliates (“Sandoz”) to resolve Faslodex (fulvestrant) patent litigation in the US relating to Sandoz’s generic fulvestrant product, for which it is seeking FDA approval.

The US Faslodex patents in question are due to expire in January 2021, with paediatric exclusivity continuing until July 2021. On 12 July 2016, the United States District Court for the District of New Jersey entered a consent judgment filed by AstraZeneca and Sandoz, which includes an injunction preventing Sandoz from launching a generic fulvestrant product until 25 March 2019, or earlier in some circumstances.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Respiratory and Autoimmunity, Cardiovascular and Metabolic Diseases, and Oncology. The Company is also active in inflammation, infection and neuroscience through numerous collaborations. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit:    


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