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FDA approves two new Seroquel XR generics Posted 16/06/2017

The US Food and Drug Administration (FDA) has approved two generic versions of Astra Zeneca’s antidepressant Seroquel XR, which has a billion-dollar market in the US.

Seroquel XR (quetiapine fumarate) is an antipsychotic used for the treatment of disorders including schizophrenia, bipolar disorder and depression. In the US, AstraZeneca markets a sustained release version of Seroquel XR, which was the first medication approved for the once-daily treatment of both depressive and manic episodes.

FDA has recently approved two new generic versions, to be made by Taiwanese firm Pharmadax and India’s Lupin Ltd (Lupin). Lupin and Pharmadax have received approval for extended release tablets of the drug, in five doses (50 mg, 150 mg, 200 mg, 300 mg and 400 mg). US sales of Seroquel XR extended release tablets were over US$1 billion for the year ending December 2016.

Lupin is a transnational pharmaceutical company that produces a range of drug products and is the fifth largest generics company by market capitalization.
Pharmadax Inc, based in Taiwan, and its subsidiary Pharmadax USA Inc, based in California, USA, will launch the product with marketing partner TruPharma LLC. The company’s chairman said Pharmadax are ‘very excited’ to gain their second approval from FDA. This is also their first approval for a controlled-release product. They say launching the product on the US market will be a ‘major milestone’ for the company.

AstraZeneca has previously filed a lawsuit against FDA to try and prevent generics competition against its blockbuster antidepressant [1]. Several further battles to protect Seroquel, which was once in the top 10 best selling drugs in the world, failed [2, 3] and there are now several generic versions available.

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AstraZeneca settles patent dispute over Seroquel XR

References
1. GaBI Online - Generics and Biosimilars Initiative. AstraZeneca sues FDA over generic quetiapine [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 16]. Available from: http://www.gabionline.net/Generics/News/AstraZeneca-sues-FDA-over-generic-quetiapine
2. GaBI Online - Generics and Biosimilars Initiative. AstraZeneca losing fight against generic quetiapine [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 16]. Available from: http://www.gabionline.net/Generics/News/AstraZeneca-losing-fight-against-generic-quetiapine
3. GaBI Online - Generics and Biosimilars Initiative. German court rules Seroquel XR patent invalid [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 16]. Available from: http://www.gabionline.net/Generics/News/German-court-rules-Seroquel-XR-patent-invalid

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Source: Lupin

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