US Court of Appeals confirms validity of AstraZeneca' Seroquel XR patent

15 February 2013

AstraZeneca announced that, on 14 February 2013, the US Court of Appeals for the Federal Circuit summarily upheld a lower court ruling that had found the formulation patent protecting its blockbuster antipsychotic Seroquel XR (quetiapine fumarate) extended release tablets in the US to be valid and infringed.

Seroquel sales have been declining as a result of generic competition in Europe, falling globally by 51% to $2.80 billion in 2012. However, in the USA, revenues from Seroquel XR continued to increase, hitting $811 million last year.

In 2012, the US District Court for the District of New Jersey found the formulation patent protecting Seroquel XR extended release tablets to be valid (the Pharma Letter March 30, 2012). The court also ruled that Anchen Pharmaceuticals, Osmotica Pharmaceutical, Torrent Pharmaceuticals, Torrent Pharma, Mylan Pharmaceuticals and Mylan Inc have infringed the Seroquel XR formulation patent.

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