August 14, 2009

First Generic Atripla Approved for Developing Nations

The first generic version of the fixed-dose combination tablet Atripla (tenofovir, emtricitabine and efavirenz) has been granted tentative approval by the Food and Drug Administration for use in resource-poor countries where the President’s Emergency Plan for AIDS Relief (PEPFAR) is scaling up access to antiretroviral (ARV) therapy.

Tentative approval means that the generic tablet is chemically equivalent with the safe and effective brand-name version and that its developer, Matrix Laboratories Limited of Hyderabad, India, has good standards in manufacturing.

Tentative approval is granted in order for a generic drug to be sold to programs participating in PEPFAR; it will not be sold in the United States or most other industrialized nations. This is because the patents that protect brand-name Atripla will not expire before 2017 and are still held in countries not included in the PEPFAR program.

Though generic versions of other HIV drugs have been granted tentative approval by the FDA, this is the first version of Atripla—a preferred treatment combination recommended by the U.S. Department of Health and Human Services—to be given the green light. The new generic will likely expand treatment choices for people in developing countries, where options are often limited.

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Previous Comments:

pelo, pretoria, 2011-05-06 08:06:39
As a south african citizen i wonder when is atripla going to be available in south Africa.Having once a day pill is better can the government please fast forward the the process of making this pill available since the generic form of the pill was granted approval by the FDA.

Barbara Williams, Galveston, TX, 2010-07-02 13:23:50
This is abominable. I am a caseworker at an HIV/AIDS services agency. I know of a gentleman who works hard and makes a decent living, but cannot afford $1800.00 a month for Atripla. His insurance capped his co pay without even telling him. Everywhere I have applied to in his behalf have denied him. I am at my wit's end.

Alan G, Washington,DC, 2009-12-08 13:56:25
It is so sad not to have generic available for Americans why they suffer and have pain to deal to get a simple cure medication called Atripla in Generic version, I believe for the sake of POZ people Obama administration should work on very hard to make this medication available in that price range max 300 monthly to Any American no matter they got insuarance or do not god sake this is a matter of life and death, what are they waiting for, more profits to Pharma companies....Ridicoulous...

James, Akron, 2009-08-19 16:51:46
Well isn't that just wonderful. Now, I understand that the poor countries need to have access to these meds, but there are plenty of people here in the U.S. and other industrialized nations that have a need for these types of programs and generic drugs. I think this country needs to start worrying about our own before we start worrying about others and their problems.

vk, tacoma, 2009-08-19 13:08:13
While it is great that they have developed a generic for Atripla that will be distributed in developing countries, where options are limited and so are one's finances. i just wish it would be able to be distributed in the States way earlier than 2017. I know we are supposed to be a progressive country and all, but come one $1800 a month for one med is crazy. I know many in the States that cannot afford that and don't have the option to get state help.

Dr Teddy, SFO, 2009-08-18 15:05:28
Mind you people without these trade laws, the generic version wouldn be available at all for any body. So instead of people in AFrica dying from lack of drugs and instead of the PEPFAR( which is tax payers money ofcourse )being used for Branded drugs, for a cost at least 10 times higher it is used to treat more people with a different drug( may not even be same quality but just good enough for saving poor Africans)AIDS drugs are paid by insurance in USA,if already paidfor it betteruse branded

mike, , 2009-08-18 14:31:49
Usual crap...US is part of the globe too. By the way the price for Atripla in Canada is supposed to be 60% less than we are subjected to

GJG, Atlanta, GA, 2009-08-18 11:53:21
This is so damned typical. I am so sick and tired of pharmaceutical companies making a profit due to my misfortune. Greedy bastards.

GKJ, Chickasha, 2009-08-15 05:34:22
So because I happen to be an an american citizen, I am denied access to a generic form of atripla because of greed of the drug companies.