The Truvada patent is about to expire. Four laboratories have already obtained authorization to produce generic versions of this HIV treatment.
Preventive treatment for HIV may well cost less in the weeks to come. At least one laboratory is ready to distribute a generic version of Truvada (emtricitabine / tenofovir): the American Mylan. As he announced on July 26, he was granted a European marketing authorization (MA) for this drug indicated for the treatment and prevention of HIV infection.
A patent at the end of the race
Three other laboratories are also in the starting blocks. Biogaran, EG and Zentiva are also licensed to produce a generic version of Truvada. Mylan is undoubtedly the most advanced: he is already announcing the cost of his production. The box of 30 tablets will cost 179.90 euros. The originator is sold at a price of 406.86 euros per box.
The savings would be considerable for the health insurance. Currently, Truvada is fully supported – both in prevention and in treatment of HIV infection. And in France, a quarter of seropositive patients receive this molecule. Patients to which are added the approximately 3,000 beneficiaries of PrEP declared at the beginning of 2017.
July could turn out to be crucial. It is in fact this month that the Truvada patent expires. But as Gilead clarified, contacted by Why actor, “In countries where the laboratory has valid Complementary Protection Certificates (CPP), this extends our intellectual property rights until 2020”.
France is one of the 12 countries subject to this provision, which makes it possible to bypass the maximum patent limit, set at 20 years. To be enthusiastic immediately would therefore be premature. Especially since obtaining an MA does not in any way prejudge an effective distribution, as specified by the National Medicines Safety Agency (ANSM) in Why actor.
A high additional cost
And the laboratory holding the patent seems determined to defend itself. “Gilead reserves the right to protect and defend its intellectual property rights in France,” commented the laboratory. A legal battle is therefore to be expected. Certain procedures have already been initiated.
In the United Kingdom, several generic laboratories attacked the CPC available to Gilead. They point out that the extension of the patent until 2020 “would inevitably lead to postponing the date of availability of generic drugs for the National Health Service England (National Health Service, England) and would therefore imply higher costs as well. than a greater budgetary burden for the latter. “
This is also the opinion of associations. In an interview with Release, Caroline Izambert – working with AIDES – estimates the additional cost of such an extension for French finances at 815 million euros.
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