DC Circuit Court says AstraZeneca not entitled to three-year exclusivity for Seroquel

In a brief opinion handed down last week by the US Court of Appeals for the District of Columbia Circuit, the Court affirmed a July 5, 2012 decision from the US District Court for the District of Columbia granting summary judgment for the US Food and Drug Administration in a case brought by Anglo-Swedish drug major AstraZeneca (LSE: AZN) over the approval of generic versions of the company’s blockbuster antipsychotic drug Seroquel (quetiapine fumarate), noted Kurt Karst, writing on Hyman, Phelps & McNamara’s FDA Law Blog.

The case concerns the applicability and scope of three-year exclusivity under FDC Act section 505(j)(5)(F)(iv) based on the FDA’s simultaneous approval of supplemental  New Drug Applications that contained information on pediatric uses of quetiapine and that made changes to the drug’s labeling to add “Table 2” of the Warnings section regarding “general safety information that is not indication-specific.”

AstraZeneca’s legal attempts to stave off FDA approval of generic Seroquel started in March 2012 when the company sought to enjoin the FDA from granting final ANDA approvals for generic Seroquel after the FDA denied without comment two citizen petitions (Docket Nos. FDA-2011-P-0662 and FDA-2011-P-0663) AstraZeneca submitted to the FDA concerning labeling carve-out issues, noted Mr Karst.