AstraZeneca loses fight over generic versions of antipsychotic drug

Hannah Blake

pharmaphorum

AstraZeneca’s bid to block the US Food and Drug Administation’s (FDA) approval of generic versions of its antipsychotic drug, Seroquel, has been rejected by a Washington federal judge. AstraZeneca’s attempt to stop the approval, by suing the FDA on March 28, was on the grounds that generic versions would violate its exclusivity rights over certain safety information.

Seroquel is considered atypical, because it results in fewer undesirable side effects, such as tics and tremors, compared to previous antipsychotic drugs. It is used to treat patients with schizophrenia and bipolar disorder.

US District Judge, Beryl Howell, granted the FDA’s motion for summary judgement with a sealed opinion, issued on June 28, and shot down AstraZeneca’s latest attempt to block the generic versions. However, Howell also found that the FDA reasonably withheld exclusivity over the safety labelling from AstraZeneca.

“By waiting until March 27, 2012 to explain its reasoning for not recognizing exclusivity for Seroquel labelling, the FDA needlessly delayed consideration of the merits of the agency’s determination, which could have been considered when AstraZeneca filed its first complaint for injunctive relief...”

Extract from a footnote on page 42 of the 49-page order by the US District Court for the District of Columbia.

While the patent for Seroquel expired in March, AstraZeneca will keep its exclusivity for certain paediatric uses until December 2nd 2012, because of the additional medical studies it conducted concerning those uses.