AstraZeneca files lawsuit against the FDA for decision regarding quetiapine product labelling and exclusivity

Tuesday, 13 March 2012

AstraZeneca today filed a lawsuit against the US Food and Drug Administration (FDA) in the US District Court for the District of Columbia to overturn the FDA’s denial on 7 March 2012 of Citizen Petitions filed by AstraZeneca with regard to SEROQUEL® (quetiapine fumarate) tablets and SEROQUEL XR® (quetiapine fumarate) extended release tablets.

In the Citizen Petitions, AstraZeneca raised important issues regarding labelling requirements for generic copies of innovative medicines, as well as data exclusivity rights granted to innovative companies that conduct new clinical trials.

AstraZeneca seeks an injunction barring the FDA from granting final marketing approval of generic quetiapine until 2 December 2012 when regulatory exclusivity expires on important clinical trial data, or, alternatively, at least until a federal court has a meaningful opportunity to review imminent FDA action regarding the pending generic marketing applications.

AstraZeneca will vigorously defend its legal rights.


About the Citizen Petitions

On 9 September 2011 AstraZeneca filed a Citizen Petition with the US Food and Drug Administration (FDA) for each of SEROQUEL and SEROQUEL XR, requesting the FDA withhold finally approving any generic quetiapine product that omits from its labelling certain hyperglycaemia and suicidality warning language that FDA required AstraZeneca to include in the labelling for SEROQUEL and SEROQUEL XR. Data associated with the hyperglycaemia warning language at issue is protected by marketing exclusivity periods expiring as late as 2 December 2012.

The FDA denied both Citizen Petitions on 7 March 2012. The patent covering the active ingredient in SEROQUEL and SEROQUEL XR expired in September 2011, with paediatric exclusivity expiring on 26 March 2012. SEROQUEL XR is covered by a formulation patent that expires in May 2017, with paediatric exclusivity expiring in November 2017. In 2011, AstraZeneca granted both Handa and Accord a license to enter the U.S. market with generic SEROQUEL XR on 1 November 2016, or earlier under certain circumstances.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. 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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