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Author Topic: Generic Epivir?  (Read 4404 times)

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Offline Assurbanipal

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Generic Epivir?
« on: October 25, 2009, 05:15:11 PM »
The US patent on Epivir/lamivudine expires Nov. 17th. (There is an extension for pediatric use to May 17, 2010).  GSK even acknowledges the patent expiration in their annual report.  (http://www.gsk.com/investors/reps08/GSK-Report-2008-full.pdf  pdf page 20  -- note the chart includes the 6 month extension for pediatric use)

Does anyone have any info on whether there is a generic version coming on to the market?  Are activists pressing the FDA for prompt approval?

To date, most of the antiretrovirals that have lost patent protection have been pretty outmoded by the time they went off patent (not a lot of people still using Zerit or DDI, although AZT still has some users).  But by the end of 2011 it looks like we could have Epivir, Emtriva, Ziagen ...

And things could be much better if generics were available for more of the meds -- ADAP funds would certainly stretch a lot further meaning fewer people on waiting lists.  There would probably be some trade-off in convenience though (most of the combo pills don't go off patent til the end of the decade)

What do we need to do to help make generics a reality?

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 veritas

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Re: Generic Epivir?
« Reply #1 on: October 26, 2009, 05:26:00 AM »

Offline Inchlingblue

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Re: Generic Epivir?
« Reply #2 on: October 26, 2009, 11:12:38 AM »
I guess generic Epivir (lamivudine) will not have any effect on Epzicom prices since they will probably continue to formulate it with the non-generic? I guess the two meds that make up Epzicom could be taken separately if one wanted in order to save money.

I doubt the price of Epzicom will come down even if Epivir is now available as a generic.

As Assurbanipal states, these questions were not that relevant with ddI and zerit and even for AZT since they were pretty much obsolete or close to it (at least in the developed world) by the time they became generic.

There will be lots of advantages as more of the better drugs become available as generic. On the one hand they will be more affordable and therefore more accessible and on the other hand, it will incentivize Big Pharma to continue making new and better drugs (maybe even some that don't require daily dosing and have negligible toxicities) so they can keep raking in the cash.

As far as "What do we need to do to help make generics a reality?" the timetable for when generics become available is what it is. There are negotiations ongoing for pharmaceutical companies to pool their copyrights and allow more generics as well as other similar programs to make generics more available but these apply to the developing world only.

Offline Assurbanipal

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Re: Generic Epivir?
« Reply #3 on: October 26, 2009, 12:52:28 PM »
[
I guess generic Epivir (lamivudine) will not have any effect on Epzicom prices since they will probably continue to formulate it with the non-generic? I guess the two meds that make up Epzicom could be taken separately if one wanted in order to save money.

I doubt the price of Epzicom will come down even if Epivir is now available as a generic.

The Epzicom combo would still be under patent until 2016, so it would not go down in price in the near term.  But I think there would be a fair number of people that switch back to the separate components.  I was on the components of Epzicom separately as part of the transition over to it and wouldn't have any problem going back to taking Epivir and Ziagen separately.  Swallowing 3 pills instead of one is no big deal -- for me, at least, the irritation is in managing pills that need to be taken two times a day rather than once daily.

I went back and looked at the costs from that first month and unfortunately most of the cost is in the Ziagen part.  A one month supply of Ziagen and Epivir from the local pharmacy cost:
Epivir $380.15
Ziagen $510.21

Three months of Epzicom from the mail order pharmacy cost $2,375.53 or a monthly rate of $791.84, which is a discount of 11% or so -- probably attributable mainly to the mail order rather than the combo pill.

So, if I went back to generic Epivir and saved 80% of the cost that would reduce my plan's annual drug costs by about $3,250.  Since my annual drugs run about $21,000, generic Epivir could potentially reduce the costs my drug plan pays out for me by 15% -- and another 20% once Ziagen is generic (assuming Epzicom and its components continue to work well for me).

Still, multiply by thousands of people and we could see real savings for ADAPs etc.  And as Emtriva and Ziagen also lose paternt protection the cost savings could spiral up.

As far as "What do we need to do to help make generics a reality?" the timetable for when generics become available is what it is. There are negotiations ongoing for pharmaceutical companies to pool their copyrights and allow more generics as well as other similar programs to make generics more available but these apply to the developing world only.

(n.b.  thinking mainly about the FDA, here and whether there was any way to apply pressure to expedite the process of approval.)
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 Assurbanipal

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Re: Generic Epivir?
« Reply #4 on: October 28, 2009, 08:44:03 AM »
After a little more research into patent expiration dates I've posted below the drugs that look like they could go generic in the next 5 years or so.

Epivir (lamivudine) 11/17/09

Emtriva (emtracitabine) 5/10/2010

Viramune (Nevirapine) 11/22/11
Ziagen (abacavir) 12/18/11

Crixivan (Indanavir) 5/9/12

Sustiva (Efavirenz) 5/21/13
Fuzeon (Enfurvirtide) 6/7/13
Viracept (Nelfinavir) 10/7/13
Rescriptor (Delviradine) 10/8/13
Kaletra also goes generic in 2013, but it looks like this is just the liquid version

Some of these drugs seem quite common in use on these forums, often as part of a combo.  In particular: Epivir, Emtriva, Ziagen, Viramune, Sustiva and Kaletra.  So, in the next 5 years or so there could be some dramatic changes in the costs of some of the options -- this may generate some pressure on us to try generic alternatives as well. 



Technical notes -- dates are for the US and are taken from the "Orange Book" published by the FDA.  Most drugs are covered by multiple patents, but the control on generic availability is typically based on the first patent (dates listed above are for the first patent).  GSK actually lists patent expiration years in their annual reports, which are consistent with the dates above plus 6 months (generally the US gives pediatric drugs another 6 months on the patent).  EU patents often run longer than the US ones.
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 Inchlingblue

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Re: Generic Epivir?
« Reply #5 on: October 28, 2009, 10:46:41 AM »
wow, thanks for the research.

So maybe when Epivir and Emtriva go generic that means Epzicom and Truvada might lose market share if people decide to take their components separately in order to save money, especially if ADAPs require it. Who knows, it might make the price of Epzicom and Truvada go down if it would mean competition from that.

Offline Assurbanipal

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Re: Generic Epivir?
« Reply #6 on: March 24, 2011, 02:06:44 PM »
Just thought I'd follow up on this and see if any treatment activists or anyone else could shed any light on why there is a delay in HIV generics hitting the US market?  With all the cost pressures on ADAP, it seems this could start to help make treatment a lot more affordable.

The 2010 GSK report confirms that they think Epivir's patent has expired in the US and EU (and you would expect them to know!, see p. 18 of the pdf file http://www.gsk.com/investors/reps10/GSK-Annual-Report-2010.pdf)

But there is still no generic approved for use in the U.S. (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=EPIVIR
Click on the drug names to get to the detail page that shows "No Therapeutic Equivalents"  i.e. no US generic)

The FDA has approved US generics only for stavudine, DDI and AZT according to this page
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm118944.htm

There are a lot of drugs approved as generics for use overseas as part of PEPFAR but that won't help US ADAP's or people with drug plans get the drugs at a more affordable price.  (People interested in the approved PEPFAR manufacturesrs can find a full list here (http://www.fda.gov/InternationalPrograms/FDABeyondOurBordersForeignOffices/AsiaandAfrica/ucm119231.htm)

Any idea what is holding up the US generics?

 
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 leatherman

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Re: Generic Epivir?
« Reply #7 on: March 24, 2011, 04:12:11 PM »
this may generate some pressure on us to try generic alternatives as well.
this was a very insightful statement ;) ;D

SC, as part of their budgeting issues, is considering passing a resolution requiring SC Medicaid to only purchase/provide generic medications.
Quote
The S.C. legislature is considering a bill that could lay the groundwork for AIDS patients on Medicaid to be treated with generic drugs, outraging patients and doctors who say the generics now available are significantly less effective than newer drugs not yet available in nonbrand form.
...
The bill before the legislature, which a Senate committee passed narrowly Tuesday, would require the state to approve Medicaid prescriptions for AIDS, cancer and mental illness drugs before patients get them.
...
"HIV drugs are not the same as penicillin or pain meds where it makes sense to use generics," said Bambi Gaddist, executive director of the Columbia nonprofit. "The AIDS generics are old drugs that just aren't prescribed anymore. To go back to the old drugs that don't work and aren't effective is to take a step decades back."
http://www.thesunnews.com/2011/02/10/1972542/sc-aids-bill-raises-ire-over-generics.html
leatherman (aka mIkIE)


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

Offline hope_for_a_cure

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Re: Generic Epivir?
« Reply #8 on: March 24, 2011, 04:31:52 PM »
SC, as part of their budgeting issues, is considering passing a resolution requiring SC Medicaid to only purchase/provide generic medications.

Oy Vey!  I wonder if the Lewin Group's Dec 2010 recommendation also helped put that bug up their butts (so to speak).  Mikie, I for one thank you for the herculean effort you are making by driving down to Columbia SC on a regular basis to speak with our Representatives.  

http://www.lewin.com/content/publications/Medicaid_Pharmacy_Savings_Report.pdf



« Last Edit: March 24, 2011, 05:01:21 PM by hope_for_a_cure »

Offline bmancanfly

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Re: Generic Epivir?
« Reply #9 on: March 24, 2011, 05:03:32 PM »
I'll be looking forward to Viramune coming off patent.   My copay,  currently $200,  will drop to $5.

But I think that doesn't happen until next year.
http://aids.emedtv.com/viramune/generic-viramune.html
"The trouble with the world is that the stupid are cocksure and the intelligent are full of doubt."

 Bertrand Russell

Offline leatherman

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Re: Generic Epivir?
« Reply #10 on: March 24, 2011, 05:42:46 PM »
driving down to Columbia SC on a regular basis to speak with our Representatives.
I've cornered myself into going down twice next week. ::) :D Because I sponsored the recent advocacy program at my ASO, I kinda have to go down with a couple of people who are going to attend a "training/lunch/and then visit with our reps" that the SC HIV Task Force is putting together. And then the org (Tell Them!) that did part of the advocacy presentation is putting on their "training/lunch/speak to legislators" dealie the next day, and I need to shepherd another group of my peeps to that one too. (Thankfully a new advocacy grant the agency got, partially for what I've been doing, will cover mileage ;) )

But I'm not really complaining, I'm actually very excited ;D to suddenly be building an advocacy group; plus the legislature is debating budgetary items (which includes that awful generic med resolution, and a resolution to remove hospice care from SC Medicaid!!) for FY2012 during the next two weeks, so now is the time to speak up here in SC.
leatherman (aka mIkIE)


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

Offline Assurbanipal

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Re: Generic Epivir?
« Reply #11 on: March 24, 2011, 05:43:56 PM »
I'll be looking forward to Viramune coming off patent.   My copay,  currently $200,  will drop to $5.

But I think that doesn't happen until next year.
http://aids.emedtv.com/viramune/generic-viramune.html

Well, I think the problem is that unless some manufacturer steps up to actually get the generic approved in the US it could be considerably beyond next year.  It isn't enough for the patent to expire -- Epivir's has expired last year --  some generic manufacturer has to step up and put the product on the market which will include an (expedited, and much easier than for the initial patent) FDA approval process.

Note I think the major patent on viramune expires 6 months after the 11/22/11 I had up above that was the initial date in the FDA orange book (they get a 6 month extension from the initial date because there are pediatric applications).
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 MitchMiller

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Re: Generic Epivir?
« Reply #12 on: March 25, 2011, 12:46:22 AM »
Personnally I think it's not only absurd, but borderline criminal negligence on the part of the FDA to certify overseas generics for PEPFAR, yet refuse to allow them to be sold in the US AFTER the patents have expired.
AIDS assistance organizations need to protest to their Republican congressmen... yes those guys that are all about saving money.  Maybe they can get this ball rolling.  I've been taking Cipla generics for years with no problems.  There's no reason they cannot be immediately be made available to patients in the US upon patent expiration since they've already been through FDA equivalence testing.  This would be some of the savings you would see:
30 day supply of ziagen: $110
30 day supply of epivir:   $27
« Last Edit: March 25, 2011, 12:52:14 AM by MitchMiller »

 


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