Seroquel generics okay, appeals court says

Share this content:
AstraZeneca is not entitled to more exclusivity with its antischizophrenic medication, an appeals court agreed last week.

The company had claimed its drug, Seroquel, deserved another three-year extension under the Food Drug and Cosmetic Act. This allows a brand drug creator an additional three years of exclusivity on a medication if there are more tests being conducted to determine if it can be used for different conditions, or if there is a change in the drug's labeling. AstraZeneca was first approved to market Seroquel in 1997, and the Food and Drug Administration denied its second petition in 2012 to keep the drug exclusive.

AstraZeneca was evaluating the use of the drug for pediatric patients, but the FDA said that was not enough of a change to grant additional exclusivity.  The company sued in U.S. District Court for the District of Columbia. The FDA followed with approving generic versions of the medication. AstraZeneca appealed, but the U.S. Court of Appeals for the District of Columbia Circuit agreed with the lower court in a decision handed down Friday.

close

Next Article in Products