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Gilead to launch injunction against Mylan and Actavis over HIV generics in Ireland

pharmafile | July 6, 2017 | News story | Sales and Marketing Actavis, Gilead, HIV, Mylan, Truvada 

Gilead is expected to launch injunctive action against rivals Mylan and Actavis over the allegation that they are planning to offer a generic version of Gilead’s antiretroviral HIV drug Truvada (emtricitabine and tenofovir disoproxil fumarate) for up to 60% cheaper than the branded treatment.

As Gilead attempts to protect its investment and its market share, the dispute has found its way into the High Court in Dublin. The company is reportedly requesting that the case be placed on the court’s fast-track commercial list, which covers cases of €1 million or more.

Trevada is used as one element of a combination therapy to treat HIV, and also used to prevent post-exposure prophylaxis (PEP) following possible exposure to the virus. Ireland’s health service, the Heatlth Service Executive (HSE), pays for both of these uses of the drug, but could not confirm its cost to the taxpayer.

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Truvada’s European patent is also due to expire this year, though Gilead has appealed for this to be extended and will argue its case before the European Court of Justice. The drug is not offered by the HSE for PrEP, which prevents contraction of the virus, as it is in other parts of the world – anyone who wishes to use the drug for this purpose can only access it via private healthcare for €400 per month.

The case is likely to be highly charged given the social impact of HIV, particularly as contraction rates are on the increase in Ireland, with 500 cases recorded last year.  

Matt Fellows

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