FDA Approves Generic Truvada

[POZ Editors]

In a move that has taken HIV advocates by considerable surprise, the U.S. Food and Drug Administration (FDA) has approved a generic formulation of Gilead Sciences’ blockbuster antiretroviral (ARV) Truvada (tenofovir disoproxil fumarate/emtricitabine). This decision could have major implications for the future cost of Truvada, to insurers and consumers alike.

The approval, which grants Teva Pharmaceuticals the right to produce generic Truvada, is for the combination tablet’s use as a component of an HIV treatment regimen and as pre-exposure prophylaxis (PrEP). Generic Truvada will come in the same form as the brand-name version: as a fixed-dose combination tablet, although the famous powder-blue color may change.

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https://www.poz.com/article/fda-approves-generic-truvada

[leatherman]

what a great win for HIV prevention and treatment!

[Jim Allen]

Yeah, this is a bit of good news indeed.

[terrymoore]

is this really NEWS? I have been using generic Truvada (Ricovir-EM) for almost 2 years.

[mecch]

And what country is that terrymoore?

Far as I know, this is the first time a developed country will approve a generic form of Truvada. 

There is no generic truvada in Switzerland thats for sure.

Generic Truvada has existed for years but it only legally sold in pharmacies in some countries.  Many countries had to respect the patent to the bitter expensive end.

[leatherman]

is this really NEWS?

considering the full patent doesn't end until 2021, this is huge news for most of the world, especially America

It looks like some agencies in the UK that have patients who have been using a generic Truvada for PReP produced outside the patent (mainly  manufactured in India) have been doing therapeutic drug monitoring to ensure that the generic version their patients have been taken has actually been up to standards.
https://daviebuyersclub.wordpress.com/home/frequently-asked-questions/

[terrymoore]

And what country is that terrymoore?

Far as I know, this is the first time a developed country will approve a generic form of Truvada. 

There is no generic truvada in Switzerland thats for sure.

Generic Truvada has existed for years but it only legally sold in pharmacies in some countries.  Many countries had to respect the patent to the bitter expensive end.

considering the full patent doesn't end until 2021, this is huge news for most of the world, especially America

It looks like some agencies in the UK that have patients who have been using a generic Truvada for PReP produced outside the patent (mainly  manufactured in India) have been doing therapeutic drug monitoring to ensure that the generic version their patients have been taken has actually been up to standards.
https://daviebuyersclub.wordpress.com/home/frequently-asked-questions/

Ohhh sorry guys - i had no idea. I must have sounded a bit arrogant - sorry. Just me being misinformed

[Jim Allen]

Understandable though lots of people and other nations taking though legal loopholes the generic version, but its huge that FDA has approved this.

Like UK as mentioned the generic drug is purchased in a legal loophole for own use as "PreP" and as pointed out in this thread GP and Clinics supporting it monitor for side effects/tolerance etc. https://www.iwantprepnow.co.uk/

[terrymoore]

So here in Thailand they openly sell the generic (my doc even recommends i buy it!) at the Red Cross Anonymous Clinic and i think also at public hospitals. Maybe it is worth it for you guys to come for a shopping trip (and also a short vacation!)?

[Jim Allen]

Well I get my meds for free so i'm okay, but Thailand is on the list of places to visit before i kick the bucket. 

Jim

[Giancarlo]

This is indeed good news for the US!
Regarding the European Union, the European Medicines Agency recommended last May the granting of a marketing authorisation for a generic version of Atripla: link.

I think this still has to go through a decision of the European Commission (and intense lobbying against it by Gilead?), but it looks promising...

[harleymc]

I wonder why the POZ Editors thought that his is research news?

[CaveyUK]

I thought the patent on Truvada ran out this year. Is it running to a different timescale in the US?

Edit: Ok, found it......It's not Truvada, but the Tenofovir component that comes off patent this year. I guess when this happens, there is a chance to prescribe generic Tenofovir along with generic 3TC (as opposed to FTC which is in Truvada)

[Jim Allen]

Only part of the patent expired in 2016/2017 if i understand it correctly, and other parts of the patent expires much later like 2020 - 2021. So the approval by the FDA of the generic is interesting. (However I admit to have no real knowledge at all of how it works)

https://www.drugs.com/availability/generic-truvada.html

[CaveyUK]

thanks Jim. I just edited my original post while you were posting...

[Giancarlo]

Regarding the European Union, the European Medicines Agency recommended last May the granting of a marketing authorisation for a generic version of Atripla: link.

A short update of the situation in France: the generic version of Atripla has been available since last March, for a monthly cost of 270€ (instead of 609€ for the "original").

[mecch]

That's some bullshit pricing for the "generic", IMO.  Crissakes.

[LeftyBowler300]

I think they have enough weight behind the reduced side effects by the TAF component in Descovy to not have to worry about the reduced cost of Truvada in developed countries.
I know I'm not switching from TAF to TDF.
Generic Descovy would have been nice, but of course they gotta make their billions off of it before that happens.