AstraZeneca sues FDA over generic Seroquel
pharmafile | March 14, 2012 | News story | Manufacturing and Production, Sales and Marketing | AstraZeneca, FDA, Seroquel, US, generics
AstraZeneca has said it filed a lawsuit against the US FDA in a bid to block approval of generic versions of Seroquel, its big-selling antipsychotic drug.
The pharmaceutical major said it was forced to take the action after the FDA denied two Citizen Petitions relating to both immediate-release Seroquel (quetiapine fumarate) and the extended release formulation Seroquel XR on 7 March.
The lawsuit is seeking an injunction blocking the FDA from granting final marketing approval for generic quetiapine until 2 December 2012, on the grounds that until that time it is the only company that can include warnings about hyperglycaemia and suicidal ideation for its quetiapine-based products.
Failing that, it would like to block approval until a federal court has “a meaningful opportunity to review imminent FDA action regarding the pending generic marketing applications”.
The patent for immediate-release quetiapine expired in September 2011, with paediatric exclusivity granting a six-month extension to 26 March, 2012. AstraZeneca claims the warning language on the label is protected by market exclusivity until December.
Meanwhile the extended-release formulation is protected to November 2017, according to the company. Last year the company granted licenses to generic companies Handa Pharmaceuticals and Accord Health to launch Seroquel XR copies in or before 2016.
The Citizen Petitions “raised important issues regarding labelling requirements for generic copies of innovative medicines, as well as data exclusivity rights granted to innovative companies that conduct new clinical trials”, said the firm in a statement.
If successful the injunction would have a deep impact on AstraZeneca’s 2012 finances, allowing it to cling onto almost another full-year of US Seroquel revenues before generic competition bites.
Last year, US sales of immediate-release Seroquel were $3.34 billion, while Seroquel XR brought in $779m. Total sales of all its Seroquel products worldwide were $5.83 billion, 17% of the company’s total product revenues.
Prior to the denial of the Citizen Petitions AstraZeneca said it expected 2012 revenues to decline by 10 per cent.
Phil Taylor
Related Content
AstraZeneca adds new heart failure target through collaboration with BenevolentAI
BenevolentAI has announced that AstraZeneca has added a novel heart failure target to its discovery …
FDA approves Roche’s HPV self-collection screening option
Roche has announced that the US Food and Drug Administration (FDA) has approved its human …
Moderna shares update on RSV vaccine
Moderna has announced that the US Food and Drug Administration (FDA) has shared that it …
