AstraZeneca is taking FDA to court over the agency’s refusal to uphold the firm’s Citizen Petitions requesting that approval of generic quetiapine products is withheld unless the product labeling includes equivalent hyperglycemia warnings to those required on AstraZeneca’s branded Seroquel and extended release Seroquel XR® antipsychotics.
The U.K. based drug firm is effectively looking to ban FDA from granting final marketing approval for generic quetiapine until December 2 when regulatory exclusivity expires on key clinical trial data associated with the warning language, or at least until a federal court has been able to review FDA action on the pending generic marketing applications. AstraZeneca filed the Citizen Petitions with FDA for Seroquel and Seroquel XR back in September 2011. The agency denied both on March 7.
The Seroquel/Seroquel XR composition patent expired in September 2011, and pediatric exclusivity is due to expire later this month. Seroquel XR is covered by a formulation patent expiring in May 2017, and a pediatric exclusivity patent expiring in November 2011. However, during September and October last year, AstraZeneca settled separate patent infringement lawsuits with Handa Pharmaceuticals and Accord Healthcare, and granted the firms licenses to take generic Seroquel XR products into the U.S. market in November 2016, or potentially earlier.
Seroquel/Seroquel XR is an atypical antipsychotic indicated for the treatment of schizophrenia, for the treatment of acute manic episodes associated with bipolar disorder, and as an add-on treatment to an antidepressant for patients with major depressive disorder. The two formulations achieved combined global sales of $5.83 billion in 2011, up 8% on 2010 figures, despite the emergence of generic versions of AstraZeneca’s original Seroquel. Market loss experienced by Seroquel as a result of generics was more than offset by a 27% growth in sales of Seroquel XR sales, which reached just shy of $1.5 billion.