AstraZeneca has won a legal battle in the US temporarily preventing the launch of a generic version of Pulmicort Respules, its childhood asthma drug with annual sales of about $1bn (£675m).
The US District Court of New Jersey granted the Anglo-Swedish pharmaceuticals group a temporary restraining order against a venture by Canadian group Apotex to launch a generic version of the medicine until further notice.
At the end of March, Apotex had received approval from the US Food and Drug Administration to market a generic version of Pulmicort Respules, but AstraZeneca immediately filed suit to prevent a launch. The New Jersey court’s decision will take precedence over the FDA approval.
Pulmicort Respules were first marketed in 2000 and are small capsules filled with liquid forms of the Pulmicort drug that are delivered via a mask-like nebuliser to asthmatic children aged one to eight.
Last year, US sales of Pulmicort were $982m, 90 per cent of which were made up from Pulmicort Repsules. AstraZeneca maintains it has patent protection on Pulmicort Repsules until 2018.
At the end of this month, the court will start to hear whether the temporary injunction against Apotex should be continued.
Savvas Neophytou, a pharmaceuticals analyst at Panmure Gordon, said it was unlikely Apotex would win the case and an earlier deal between AstraZeneca and Teva, the Israeli generics maker, would still see Teva market the first generic Pulmicort Repsules toward the end of this year.
“I don’t think this decision is really something that is transformative to the AstraZeneca investment thesis,” he said.
“I would be very surprised to see Apotex winning at the end of April. I expect to see Teva being the first Pulmicort Respules generic to be launched mid-December and AstraZeneca is going to get quite a significant profit-share from that product.”
Patent protection is increasingly important for many large drugs companies, which are coming under pressure as their blockbuster drugs near the end of their patent life, and the pipelines of drugs in development that would ordinarily replace these sales look sparse.
The patent on Pfizer’s best-selling cholesterol drug Lipitor will expire in most countries next year, while British specialty pharma group Shire has been facing generic competition on its hyperactivity drug Aderall since the start of this month.
Shares in AstraZeneca closed down 12p at £23.85.
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