Big savings expected with new generic antipsychotic

FDA tentatively approved the abbreviated new drug application (ANDA) for generic quetiapine fumarate extended-release tablets (brand Seroquel XR, AstraZeneca) to treat schizophrenia and manic/mixed episodes associated with bipolar disorder.

There are no other generics of Seroquel XR available in the US market because the product is still under AstraZeneca's patent protection until November 1, 2017, according to the generic manufacturer, Intellipharmaceutics International.

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The new generic represents significiant savings to the US healthcare system, as US sales of Seroquel XR reached around $1.2 billion for the 12 months ended August, 2016, according to Symphony Health Solutions.

Intellipharmaceutics said the approval is tentative because the company cannot launch the product until November 1, 2016, because of a settlement with AstraZeneca. Then, the company can launch its generic versions of the 50, 150, 200, 300 and 400 mg strengths of the generic Seroquel XR, subject to FDA final approval of the company's ANDA for those strengths.

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“Such FDA final approval is subject to a 180-day exclusivity period relating to a prior filer or filers of a generic equivalent of the branded product,” said Intellipharmaceutics in a statement. “To our knowledge, two companies have first-to-file status and may be in a position to launch on November 1, 2016, although we cannot be certain of that date. Our intent is to launch these strengths after FDA final approval following expiry of the other companies' exclusivity period(s).”

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