PharmExec Blog

AZ's Seroquel Battle with FDA: A Mark of Desperation?

By Ana Nicholls, Healthcare Analyst at the Economist Intelligence Unit.

Is it a mark of desperation? UK-based pharma company AstraZeneca has resorted to suing the US Food and Drug Administration in a bid to stop it from approving generic competition to Seroquel, the company’s blockbuster anti-depressant, before December 2012. The core patent for Seroquel IR expired in September last year, and its paediatric patent runs out this month, although Seroquel XR (the later version) still has protection till 2017.

The FDA has yet to approve a generic version, and AstraZeneca is arguing that it should not do so. The company claims that important decisions have still not been made over warning labels on the generic versions of Seroquel IR, which need to mimic those on the original, while it still has data exclusivity rights stemming from the clinical trials it has conducted.

AstraZeneca tried a Citizens’ Petition against the FDA earlier this month, with no joy, so it is now trying a lawsuit. The case is a long shot, but the costs will certainly be far lower than the losses the company will incur when Seroquel’s patent expires. The drug generated sales of US$4.3bn worldwide last year, of which US$3.3bn was in the US. Moreover, if AstraZeneca wins, then it (and other companies) may also have developed another way of extending protection for many of the drugs that are coming off-patent.

If so, that would be very welcome news in this, the steepest year of the patent cliff. This year, around US$27bn-worth of blockbuster sales will be exposed to generic competition in the US, according to Fitch Ratings. AZ, along with Pfizer and Forest Laboratories of the US, is one of the companies hardest hit. AZ calculates that it lost almost US$2bn in revenue during 2011 as a result of generic competition. Other companies have tried different tactics to protect their patents – Pfizer, for example, struck exclusivity deals with pharmacy benefits managers to protect sales of Lipitor after its US patent expired late last year.

Yet the mood in the US is firmly against pharma companies who are seen as blocking competition, making the likelihood of AZ winning its case appear remote. Though attempts to legislate have foundered, the current US government has campaigned against what it dubs “pay-for-delay” tactics, which mainly involve deals between pharma companies and their potential generic competitors. The chairman of the Federal Trade Council Jon Leibowitz claimed last year that such arrangements cost consumer US$3.5bn a year in higher drug prices.

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  1. Tony Frost
    Posted March 15, 2012 at 6:30 am | Permalink

    Drugs only have the same patent life (20 years) as any other invention, but a lot of that is chewed up by the 10 – 12 years it typically takes to invent and then test them. High failure rates contribute to extreme development costs, so the few successful drugs have to pay for all the failures (about 1000:1, per Tufts University).

  2. Posted March 15, 2012 at 8:39 am | Permalink

    Association between Seroquel or quetiapine,and hyperglycemia.

    There is concern Seroquel,like other atypical antipsychotic drugs, has the potential to cause metabolic disorders, particularly hyperglycemia (excess sugar) and diabetes. Atypical antipsychotics cause the body to metabolize fat instead of carbohydrates, leading to insulin resistance to the excess carbohydrates.

    At the same time they promote fat accumulation.I was a patient back in 1996-2000 who was a subject of Eli Lilly’s Zyprexa ‘viva’ Zyprexa’ off label sales promotion.I was given it as an ineffective costly treatment for PTSD It gave me diabetes as a side effect.–Daniel Haszard

  3. malcolm
    Posted March 20, 2012 at 4:57 am | Permalink

    It is true that much of the patent term is taken up in regulatory processes, but much of this is returned through patent term extensions which take into the account of the FDA processing time or in Europe due to supplementary patent certification

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