AstraZeneca was hit by another generic challenge today after the Canadian company Cobalt Pharmaceuticals said it was seeking US approval to sell a copycat version of the cholesterol treatment Crestor, one of AstraZeneca's best-selling drugs.
Cobalt plans to launch a cheap version before Crestor's patents expire. The cholesterol treatment - one of the drugs that AstraZeneca is depending on to drive profits - is covered by patents that are valid until 2016, 2020 and 2021.
But Cobalt, which plans to market generic versions of Crestor tablets in four different strengths, claims that these will not infringe on the two patents that expire in 2016 and 2020.
AstraZeneca now has a 45-day window to decide whether to take Cobalt to court. If it does, the US Food and Drug Administration will not be able to approve the generic versions for another 30 months.
The group said it was evaluating Cobalt's allegations and certifications, adding it had full confidence in the intellectual property portfolio protecting Crestor.
The news is a further blow to the drug company, as it already faces generic challenges to its two best-selling drugs - Nexium for stomach ulcers, and Seroquel for schizophrenia and bipolar depression.
Last year, sales of Crestor were over $2bn (£961m), with more than 9 million patients treated and almost 72m prescriptions written since launch.
Nexium made sales of over $5bn for the first time, and Seroquel revenues came in at $3.4bn.
To top it all, the European Patent Office last month revoked a patent for Symbicort, AstraZeneca's two-in-one asthma drug that made $1.2bn in sales worldwide, including $1.02bn in Europe. This means that after the end of data exclusivity in 2010, generic companies will be able to get hold of the company's data on the drug and make their own treatments in Europe.
AstraZeneca is also reporting its third quarter results today. Investors will be looking at sales of Nexium, as well as Symbicort's progress in the US, where it is challenging GlaxoSmithKline's Advair asthma drug. They will also be paying close attention to how the integration of MedImmune, AstraZeneca's $15.6bn acquisition, is going.
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