AstraZeneca’s Seroquel US Lawsuit Against The FDA Dismissed

AstraZeneca has suffered a further obstacle in their bid to delay generic competition access to their Seroquel franchise after a lawsuit launched against the US Food and Drug Administration (FDA) concerning its stance on copies of the antipsychotic was thrown out of court.

Earlier this month, the Anglo-Swedish drug maker stepped up their fight to safeguard the near £1bn yearly sales of Seroquel, by taking legal action against the US regulatory body after the FDA denied AstraZeneca’s Citizen Petitions.

Last year, AstraZeneca filed a Citizens Petition which could have delayed generics entering the market.  However, the Food and Drug Administration this month denied the petition, which requested that the FDA withhold approving any generic that did not carry the same warnings, which relate to the risk of hyperglycaemia, or high blood sugar, and suicidal thoughts, and are required for AstraZeneca’s branded versions of Seroquel (quetiapine) and Seroquel XR.

It is thought doubtful that generics would not carry a similar label. But, AstraZeneca argued that research they conducted, which led to the addition of extra information on Seroquel’s label in 2009, means that the language on the label is protected by exclusivity agreements which expire as late as December 2nd 2012.

Following the denial of the Citizens Petition, AstraZeneca aimed to seek an injunction excluding the granting of final marketing approval of copycat forms of the drug until December 2 or “at least until a federal court has a meaningful opportunity to review imminent FDA action regarding the pending generic marketing applications.”  However, on Friday a court for the District of Columbia denied the company’s appeal for a preliminary injunction and dismissed the lawsuit without prejudice.

AstraZeneca commented that they continue “to believe strongly in the merits of its position and is evaluating its options.”  In the USA, the patent covering instant-release quetiapine ran out in September 2011, and paediatric exclusivity will expire on March 26.

Last week, the UK High Court stated that the patent on Seroquel XR is invalid.


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