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Author Topic: Are there any generic meds for HIV?  (Read 2589 times)

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Offline LiveWithIt

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Are there any generic meds for HIV?
« on: February 15, 2012, 01:41:57 PM »
I think usually a medication will become available in generic form after 7 years, but I know many HIV meds have been out much longer but I don't think they are available as a generic version.  I wonder why, or if it has anything to do with so many people being able to get their medications free or at a discounted rate.
Pray God you can cope
I know you have a little life in you yet.
I know you have a lot of strength left.

Offline Tim Horn

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Re: Are there any generic meds for HIV?
« Reply #1 on: February 15, 2012, 01:52:19 PM »
Zidovudine (AZT) and didanosine (ddI) are the only meds available generically in the U.S. Everything else is still patent protected.

Drugs are typically given 20-year patents, but the patent protection is put into place when the drugs are in very early stages of development. So, while some drugs that took a long time to be developed and approved are available for generic production within as little as seven years post-approval, it can seem longer for rapidly developed HIV meds, which generally don't quality for generics for 12 or so years after they're approved.

Correction: A co-formulation of zidovuine and lamivudine (Combivir) is also available generically in the U.S.
« Last Edit: February 15, 2012, 03:41:23 PM by Tim Horn »

Offline spacebarsux

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Re: Are there any generic meds for HIV?
« Reply #2 on: February 15, 2012, 03:01:20 PM »
So, while some drugs that took a long time to be developed and approved are available for generic production within as little as seven years post-approval, it can seem longer for rapidly developed HIV meds, which generally don't quality for generics for 12 or so years after they're approved.

CIPLA made viraday (generic Atripla) a few years back and I just read that Atripla was approved by the FDA in 2006, so this was just good luck ? :-\ Can't complain. I hope other generics come out just as quick if not sooner.
Infected-  2005 or early 2006; Diagnosed- Jan 28th, 2011; Feb '11- CD4 754 @34%, VL- 39K; July '11- CD4 907@26%,  VL-81K; Feb '12- CD4 713 @31%, VL- 41K, Nov '12- CD4- 827@31%

Offline leatherman

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Re: Are there any generic meds for HIV?
« Reply #3 on: February 15, 2012, 03:16:29 PM »
CIPLA made viraday (generic Atripla) a few years back and I just read that Atripla was approved by the FDA in 2006, so this was just good luck ? :-\
not good luck at all. it was simply not recognizing (ignoring) the patents other countries had placed on drugs

Quote
Indian law from 1972 until 2005 allowed no (end-product) patents on drugs, and provided for compulsory licensing, Cipla was able to manufacture medicines which enjoyed patent monopoly in certain other countries (particularly those where large, multinational pharmaceutical companies are based). By doing so, as well as by making an executive decision not to make profits on AIDS medication, Cipla reduced the cost of providing antiretrovirals to AIDS patients from $12,000 and beyond (monopoly prices charged by international pharma conglomerates) down to under $100 per year. While this sum remains out of reach for many millions of people in Third World countries, government and charitable sources often are in a position to make up the difference for destitute patients.
http://en.wikipedia.org/wiki/Cipla

Quote
Generic threats to Gilead in HIV Therapy

The patents for Sustiva (used in Atripla) will expire in 2013 and it is prudent to assume that generics will be on the market. This is a thread to Gilead because patients may be able to reduce costs by taking generic Sustiva plus Truvada instead of the more expensive Atripla. Indeed, this is partly why TMC278/Truvada and the Quad regimen are being developed. There is a danger that the cost savings will not be outweighed by the benefits of TMC278/Truvada. Quad is aimed at treatment experienced patients.

Furthermore, Viread will start to lose its patents in 2017 and there is already significant competition from a large Indian generic manufacturer Cipla. Viraday is a generic version of Atripla that Cipla sells worldwide for a fraction of the cost. Indeed, Cipla claims to be the worldwide leader in generic anti HIV therapy sales.

Moreover, if Cipla and others establish themselves in the US via selling generic Sustiva to be combined with Truvada than they could be establishing a foothold with which to launch much cheaper generic copies of Truvada when the Viread patents start to expire in 2017
http://earningsview.blogspot.com/2011/01/gilead-facing-challenges.html
leatherman (aka mIkIE)


chart from 1992-2013; updated 2/09/13  Reyataz/Norvir/Truvada

Oh my friends, my friends forgive me
That I live and you are gone.
There's a grief that can't be spoken.
There's a pain goes on and on.
Empty chairs at empty tables
Where my friends will meet no more.

"Empty Chairs at Empty Tables" from Les Miserables

Offline spacebarsux

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Re: Are there any generic meds for HIV?
« Reply #4 on: February 15, 2012, 03:29:02 PM »
Oh yeah..!

Recently, there was a huge demonstration here in India, protesting against the free trade agreement being negotiated b/w India and the EU that could severely curtail India's production and export of affordable ARVs.

http://www.washingtonpost.com/world/asia_pacific/india-eu-trade-pact-could-boost-aids-treatment-costs-health-workers-say/2012/02/10/gIQAGAKR4Q_story.html
Infected-  2005 or early 2006; Diagnosed- Jan 28th, 2011; Feb '11- CD4 754 @34%, VL- 39K; July '11- CD4 907@26%,  VL-81K; Feb '12- CD4 713 @31%, VL- 41K, Nov '12- CD4- 827@31%

Offline Tim Horn

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Re: Are there any generic meds for HIV?
« Reply #5 on: February 15, 2012, 03:39:09 PM »
CIPLA made viraday (generic Atripla) a few years back and I just read that Atripla was approved by the FDA in 2006, so this was just good luck ? :-\ Can't complain. I hope other generics come out just as quick if not sooner.

Problem is, Viraday (like many other generics produced by Cipla and others) isn't available in the U.S. -- it's availability is primarily limited to the global south.  This is made possible with the "paragraph 6 waiver" issued by the World Trade Organizations, which basically allows countries unable to produce pharmaceuticals at home and are suffering serious health crises to important ARVs under compulsory licenses.



Offline Tim Horn

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Re: Are there any generic meds for HIV?
« Reply #6 on: February 15, 2012, 03:44:17 PM »
A good review of the development and availability of generics in the global south can be found here: http://www.avert.org/generic.htm

Offline LiveWithIt

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Re: Are there any generic meds for HIV?
« Reply #7 on: February 15, 2012, 04:37:59 PM »
It's ridiculous than HIV medicine can cost $25,000  a year or more, and if you can't pay for it, someone has to.  I know I am grateful for the help I receive.

Another thing that bugs me about Pharmaceutical companies is that they claim that the cost is so high due to research, but they spend as much on advertising as they do on research.  I think advertising for prescription medication is stupid, a doctor should tell you what you need, you shouldn't ask for something because you saw a commercial about it, which is what they want people to do.
Pray God you can cope
I know you have a little life in you yet.
I know you have a lot of strength left.

Offline madbrain

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    • My personal site
Re: Are there any generic meds for HIV?
« Reply #8 on: February 15, 2012, 08:00:59 PM »
It's ridiculous than HIV medicine can cost $25,000  a year or more, and if you can't pay for it, someone has to.  I know I am grateful for the help I receive.

Another thing that bugs me about Pharmaceutical companies is that they claim that the cost is so high due to research, but they spend as much on advertising as they do on research.  I think advertising for prescription medication is stupid, a doctor should tell you what you need, you shouldn't ask for something because you saw a commercial about it, which is what they want people to do.

Agree wholeheartedly. In many countries with universal healthcare, advertising for prescription drugs is simply prohibited.

I have to wonder how much the pharmaceutical companies spend on their HIV drugs advertising. My guess is not very much. You never see ads for them on TVs. I have only seen them in some magazines targeted to the gay population. I figure those ads can't be too expensive. The bribes they pay to doctors to prescribe certain meds over others probably cost a whole lot more.

Offline buginme2

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Re: Are there any generic meds for HIV?
« Reply #9 on: February 15, 2012, 08:09:08 PM »
CIPLA made viraday (generic Atripla) a few years back and I just read that Atripla was approved by the FDA in 2006, so this was just good luck ? :-\ Can't complain. I hope other generics come out just as quick if not sooner.

One interesting thing (I am a nerd, so I may be the only one who finds this interesting) is that in the United States drugs are patented based on the finished product.  So the final chemical composition of Atripla is patented.

In India, it is the manufacturing process that is patented not the finished drug itself.  So Cipla is able to produce Atripla using a different manufacturing method than another drug company making the same drug, thereby not violating India's patent laws.

"All I need are some tasty waves, a cool buzz, and I'm fine."

http://www.youtube.com/watch?v=6e0gcEC1TWE

Offline Assurbanipal

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Re: Are there any generic meds for HIV?
« Reply #10 on: February 16, 2012, 03:02:01 PM »
CIPLA made viraday (generic Atripla) a few years back and I just read that Atripla was approved by the FDA in 2006, so this was just good luck ? :-\ Can't complain. I hope other generics come out just as quick if not sooner.

The FDA gives "tentative approval" to generic versions of HIV drugs to indicate that they are safe and effective and can be used in American aid programs abroad such as PEPFAR.  The approval is "tentative", if the brand drugs are still protected by US patents.

More info here: http://www.fda.gov/InternationalPrograms/FDABeyondOurBordersForeignOffices/AsiaandAfrica/ucm119231.htm

The FDA maintains a page of generic HIV drugs available in the US here: http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm118944.htm
5/06 VL 1M+, CD4 22, 5% , pneumonia, thrush -- O2 support 2 months, 6/06 +Kaletra/Truvada
9/06 VL 3959 CD4 297 13.5% 12/06 VL <400 CD4 350 15.2% +Pravachol
2007 VL<400, 70, 50 CD4 408-729 16.0% -19.7%
2008 VL UD CD4 468 - 538 16.7% - 24.6% Osteoporosis 11/08 doubled Pravachol, +Calcium/D
02/09 VL 100 CD4 616 23.7% 03/09 VL 130 5/09 VL 100 CD4 540 28.4% +Actonel (osteoporosis) 7/09 VL 130
8/09  new regimen Isentress/Epzicom 9/09 VL UD CD4 621 32.7% 11/09 VL UD CD4 607 26.4% swap Isentress for Prezista/Norvir 12/09 (liver and muscle issues) VL 50
2010 VL UD CD4 573-680 26.1% - 30.9% 12/10 VL 20
2011 VL UD-20 CD4 568-673 24.7%-30.6%
2012 VL UD swap Prezista/Norvir for Reyataz drop statin CD4 768-828 26.7%-30.7%

Offline bmancanfly

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Re: Are there any generic meds for HIV?
« Reply #11 on: February 16, 2012, 07:13:35 PM »
I believe the patent for Viramune expires in May 2012.
"The trouble with the world is that the stupid are cocksure and the intelligent are full of doubt."

 Bertrand Russell

Offline aztecan

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  • 28 years positive, 56 years a pain in the butt
Re: Are there any generic meds for HIV?
« Reply #12 on: February 17, 2012, 10:54:49 AM »
I read just the other day that 3TC (Epivir) is now available as a generic.

HUGS,

Mark
"May your life preach more loudly than your lips."
~ William Ellery Channing (Unitarian Minister)

Offline spacebarsux

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Re: Are there any generic meds for HIV?
« Reply #13 on: February 17, 2012, 04:02:12 PM »

In India, it is the manufacturing process that is patented not the finished drug itself. 

The patent laws were amended not so long ago so the end product is patented too. The more important thing is that the supply of generic ARVs in the developing world could potentially be thrown into jeopardy once this India-EU FTA is signed and sealed- i.e. if the Indian Govt. gets bullied in the negotiations with Europe.
Infected-  2005 or early 2006; Diagnosed- Jan 28th, 2011; Feb '11- CD4 754 @34%, VL- 39K; July '11- CD4 907@26%,  VL-81K; Feb '12- CD4 713 @31%, VL- 41K, Nov '12- CD4- 827@31%

 


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