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AstraZeneca takes legal action to delay generic quetiapine in US

BMJ 2012; 344 doi: https://doi.org/10.1136/bmj.e2099 (Published 15 March 2012) Cite this as: BMJ 2012;344:e2099
  1. Nigel Hawkes
  1. 1London

AstraZeneca has filed a lawsuit against the US Food and Drug Administration in a bid to delay the entry into the market of generic versions of its successful drug quetiapine fumarate (Seroquel).

The patent covering quetiapine, an antipsychotic, expired last September, with paediatric exclusivity due to expire on 26 March. The entry of generic versions is expected to halve AstraZeneca’s earnings from the drug in the US.

AstraZeneca’s lawsuit seeks an injunction against the FDA granting final marketing approval for generic versions until 2 December …

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