AstraZeneca denied extended rights to antipsychotic drug

The Food and Drug Administration (FDA) gives pharmaceutical manufacturers a time when they can market their drugs without competition from generic brands, and law allows the FDA to extend that period of exclusivity when the medication undergoes testing that reveals a change in the drug’s label or its uses.

AstraZeneca said its drug, Seroquel, deserved the three-year extension following testing of the drug’s side effects and evaluations about its potential use in children. The FDA said the tests did not result in substantial enough changes to the medication’s label to warrant the additional exclusivity. The court agreed, deferring to the regulator’s interpretation of the law.

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The company began marketing Seroquel in 1997, “largely” without generic competition, the court noted. In 2008, the regulator asked the manufacturer to complete studies to determine the risk of noted side effects, such as high blood pressure.

Following those studies, as well as additional tests to see if Seroquel could be taken by children, the company asked the FDA in 2011 to extend its limited competition rights – and the regulator ultimately responded that the safety information updated by the testing wasn’t sufficient enough to give the company more time.

The FDA then began accepting applications in 2012 for the approval of generics of the drug, an antipsychotic also used to treat patients with seizures or those diagnosed with bipolar disorder.

Judge David Sentelle, of the U.S. Court of Appeals for the District of Columbia, said the regulator’s decision hasn’t varied with its past judgments on the issue and that AstraZeneca could not prove “a genuine dispute” exists.

Using a Supreme Court case that gives federal regulators deference in court battles, Sentelle said the FDA’s interpretation of the law defines granting the exclusivity extension.

“The FDA has exhaustive regulations detailing the parameters of the application process, including how to amend pending supplements and applications,” the judge wrote in his decision. “AstraZeneca makes no attempt to show that these procedures are contrary to the statute. Nor has AstraZeneca shown that the FDA’s application of the law to the relevant facts was arbitrary or capricious.”