AstraZeneca Sues FDA Over Top Anti-Depressant

By FOXBusiness

AstraZeneca (NYSE:AZN) is suing the U.S. Food and Drug Administration to try and extend its exclusive hold on its best-selling anti-depressant drug as a wave of patent expirations and new, more affordable generics continue to weigh on pharmaceutical giants.

The Anglo-Swedish drug maker was denied by the FDA on March 7 for to extend its hold on Seroquel until the end of the year. AstraZeneca has asked the FDA to not grant final marketing approval of generic quetiapine until Dec. 2.

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The suit, filed in the U.S. District Court in Washington, D.C., seeks to overturn a recent ruling by the FDA that generic copies of the pill would not have to carry the same warnings about possible side effects, including suicidal thoughts, which has been a major turnoff to these types of drugs, as well as elevated blood sugar.

The drug is the fifth best-selling in the U.S. and has been AstraZeneca’s biggest bread winner.

“AstraZeneca will vigorously defend its legal rights,” the company said in a statement.

The patent on the active ingredient in Seroquel expired in September.

The world’s largest drug companies have been facing a so called “patent cliff” over the past few months that have caused them to lose exclusivity of some of their top-selling drugs and compete with generic companies, which often sell their products at a more affordable price and follow less stringent regulations over labels and testing.

One of the more well-known such cases occurred in November, when Pfizer (NYSE:PFE) lost exclusivity for its cholesterol pill Lipitor. Bristol-Myers’ (NYSE:BMY) best-selling blood clot treatment Plavix is set to expire in May.