AstraZeneca Sues FDA For Refusing To Delay Seroquel Generics

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AstraZeneca Plc (AZN,AZN.L) has filed a lawsuit in a U.S. District Court asking to overturn the U.S. regulators' denial of a bid to delay the entry of generic versions of its antipsychotic blockbuster Seroquel. The Anglo-Swedish drug maker said Tuesday it will vigorously defend its legal rights. The patent covering the active ingredient in the drug expired in September last year, with pediatric exclusivity expiring this month.

Last week, the company revealed that the U.S. Food and Drug Administration denied its Citizen Petitions requesting that the FDA withhold finally approving any generic with labeling that omits certain hyperglycemia warnings required in the labeling for Seroquel (quetiapine fumarate) tablets and Seroquel XR extended-release tablets.

It was on September 9, 2011 that AstraZeneca filed a Citizen Petition with the FDA for both Seroquel and Seroquel XR, requesting to withhold finally approving any generic that omits certain hyperglycemia and suicidality warnings in labeling. According to the company, data associated with the hyperglycemia warning language at issue is protected by marketing exclusivity periods expiring as late as December 2, 2012.

The patent covering the active ingredient in Seroquel and Seroquel XR expired in September 2011, with pediatric exclusivity expiring on March 26. Seroquel XR is covered by a formulation patent that expires in May 2017, with pediatric exclusivity expiring in November 2017.

AstraZeneca said it raised important issues in the Citizen Petitions, regarding labeling requirements for generic copies of innovative medicines, as well as data exclusivity rights granted to innovative companies that conduct new clinical trials.

In the US District Court for the District of Columbia, AstraZeneca filed the suit seeking an injunction barring the FDA from granting final marketing approval of generic quetiapine.

The barring should be until December 2 when regulatory exclusivity expires on important clinical trial data, or, alternatively, at least until a federal court has a meaningful opportunity to review imminent FDA action regarding the pending generic marketing applications, the company noted.

AstraZeneca in 2011 granted both Handa and Accord a license to enter the U.S. market with generic Seroquel XR on November 1, 2016, or earlier under certain circumstances.

In February, the company had noted that the anticipated loss of market exclusivity for Seroquel IR along with other ongoing generic competition and government interventions on pricing would hurt its fiscal 2012 revenues. In the year 2011, revenues from Seroquel sales grew 8 percent with 3 percent increase in Seroquel IR and 27 percent climb in sales of Seroquel XR. US sales of Seroquel grew 10 percent and Seroquel XR sales were up 22 percent.

In London, AstraZeneca shares are currently trading at 2,881.50 pence, up 5 pence or 0.17 percent.

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