Thursday, April 05, 2012

NHS looks set to save £20m as antipsychotic drug Seroquel comes off patent | BMJ

  1. Nigel Hawkes

Author Affiliations

  1. 1London

The launch of generic versions of an antipsychotic drug at the end of last month is likely to save the NHS as much as £20m (€24m; $32m).

The generics manufacturer Teva launched versions of quetiapine (marketed by AstraZeneca as Seroquel) and the prolonged release version of the drug (Seroquel XR) in the United Kingdom on 30 March. Its version of quetiapine will cost £6.08 for a pack of 60 pills of the 25 mg dose, whereas the branded product cost £30.50 a pack. The NHS in England spends about £90m a year on the drug so is likely to save many millions as a result of the patent expiry.

AstraZeneca strongly resisted the lifting of the patent on Seroquel XR, arguing in the British courts that the technology used to prolong release of the drug effectively meant that it justified a separate patent from the original version. But the High Court ruled on 22 March that a separate patent was not justified and that the existing patent had expired.

In the United States, by contrast, the district judge Joel Pisano ruled on 30 March that the company’s patent on the prolonged release version was valid. That means this version of the drug will remain patented until 2017 in the US. A Dutch court made the same decision on 7 March, and a decision is awaited in Spain. So far only the UK has lifted the patent.

But AstraZeneca was not so lucky in another of its actions in the US: an attempt to prevent the patent being lifted on the original drug. The company had sought an injunction against the US Food and Drug Administration in the federal court, seeking to delay the FDA’s approval of generic versions of quetiapine (BMJ 2012;344:e2099, 15 Mar, doi:10.1136/bmj.e2099).

AstraZeneca’s case rested on a labelling issue. It argued that the generic versions would have to carry the same warnings about the risk of high blood sugar and suicidal thoughts as the branded drug, and because these warnings were the result of the company’s own research it was entitled to exclusivity over the information until December this year, three years after the FDA licensed the inclusion of the warnings on labels of Seroquel.

Success would have extended exclusivity for Seroquel in the US for a further eight months, worth $2bn in sales. The FDA had rejected the company’s argument, asserting that it could not determine labelling issues until it had decided whether to issue a licence for the generic version, which at the time it had not done. On 23 March a judge heard these assurances and dismissed AstraZeneca’s call for an injunction.

However, the FDA did issue such licences as soon as the main patent expired on 27 March, prompting a second call for an injunction issued on 28 March and heard the same day. Judge Beryl Howell ruled against AstraZeneca on the grounds that it was unlikely to win the case on its merits. Temporary relief from the FDA’s actions could not be granted, she ruled, if the company’s case against the agency’s main action was unlikely to be upheld. But she was strongly critical of the FDA’s behaviour, saying that it had made “tactical decisions” to thwart AstraZeneca.

At the 23 March hearing the FDA had argued that an injunction would be premature because it had not made any decision about licensing generic versions. “It may be months or even years” before such a decision would be made, it argued. Yet four days later it had approved the licences, Judge Howell said, which amounted to “hiding the ball” from AstraZeneca. The FDA at the earlier hearing had been “less than forthright” about the status of its decision making, the judge said.


Cite this as: BMJ 2012;344:e2520

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