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Generic Gleevec


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#1 Beanie

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Posted 23 May 2011 - 09:07 AM

Does anyone know how long after a patent runs out can a generic drug be made?  I am just hoping there will be one ASAP because I have to pay $460.00 a month for my pills. Because there are so few people that take it, I wonder if there will be an urgency to make a generic.  Does anyone know how this works?



#2 CallMeLucky

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Posted 23 May 2011 - 09:51 AM

I believe the patent expires on Gleevec in 2015, at which point there will likely be a domestic generic available that is FDA approved.  Currently there is a generic in India, but it is not FDA approved to be sold inthe US.

In the mean time there are patient assistance programs by Novartis and LLS.  If you are having trouble paying for your meds you should reach out to them.


Date  -  Lab  -  Scale  -  Drug  -  Dosage MG  - PCR
2010/Jul -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 1.2%
2010/Oct -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 0.25%
2010/Dec -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 0.367%
2011/Mar -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 0.0081%
2011/Jun -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 0%
2011/Sep -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 0.00084%
2011/Dec -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 0%
2012/Mar -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 0.004%
2012/Jun -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 0%
2012/Sep -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 0%
2012/Dec -  MSKCC  -  Non-IS  -  Sprycel  - 100 - 0%
2013/Jan -  Quest  -  IS  -  Sprycel  -  50-60-70  - 0%
2013/Mar -  Quest  -  IS  -  Sprycel  -  60-70  - 0%
2013/Apr -  CUMC  -  Non-IS  -  Sprycel  - 50 - 0.036%
2013/May -  CUMC  -  Non-IS  -  Sprycel  - 50 - 0.046%
2013/Jun -  Genoptix  -  IS  -  Sprycel  - 50 - 0.0239%
2013/Jul -  Genoptix  -  IS  -  Sprycel  - 70 - 0.0192%
2013/Jul -  Genoptix  -  IS  -  Sprycel  - 70 - 0.0034%
2013/Oct -  Genoptix  -  IS  -  Sprycel  - 70 - 0.0054%
2014/Jan -  Genoptix  -  IS  -  Sprycel  - 70 - 0.0093%
2014/Mar -  Genoptix  -  IS  -  Sprycel  - 100 - 0.013%
2014/Apr -  Genoptix  -  IS  -  Sprycel  - 100 - 0.0048%
2014/Jul -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2014/Nov -  Genoptix  -  IS  -  Sprycel  - 100 - 0.047%
2014/Dec -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2015/Mar -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2015/Jun -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2015/Sep -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2015/Dec -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2016/Mar -  Genoptix  -  IS  -  Sprycel  - 100 - 0.0228%
2016/Jun -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2016/Sep -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2016/Dec -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2017/Mar -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2017/Jun -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2017/Sep -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2017/Dec - Genoptix  -  IS  -  Sprycel  -  100 - 0%
 

 


#3 MACELPatient

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Posted 23 May 2011 - 09:52 AM

The patent expires in 2015 at which time, there will a generic available.  Hang tough.

http://community.lls...d/7520?tstart=1

http://community.lls...age/31755#31755



#4 PhilB

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Posted 23 May 2011 - 10:17 AM

The company currently selling generic Gleevec in India has already got most if not all of its ducks in a row to start selling in the US the day Gleevec comes of patent so you just need to make it through the next 4 years.  I believe Sprycel comes off patent in 2020 and Tasigna in 2023. - which might be another reason to chose Sprycel over Tasigna if Gleevec isn't working fro someone!  I'd be amazed if companies aren't champing at the bit to get a generic out there in time for those too.  With the UK authorities trying to avoid paying for the second line drugs I've been giving a lot of thought to whether I could afford to pay for Sprycel until 2020 if G fails!

Regards

Phil



#5 Happycat

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Posted 23 May 2011 - 02:49 PM

I'm sure the generic companies will be lining up for a piece of $4B in sales.  Generic companies are allowed to start working on the process development ahead of time, so they can have all the paperwork and regulatory stuff ready to hit the shelves as soon as the patent expires.   I would expect you would have access to generic G within 6 mo of patent expiration, if not sooner.  (And I'll lay any hold up squarely on the FDA.  Just my own bias.  I've had to deal with the DEA before, and all I can say is that the government has its own timeline.  Nothing is ever urgent to them.)

Traci



#6 Beanie

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Posted 23 May 2011 - 06:21 PM

I did get assistance from Novartis for the first year but just got denied when I reapplied.  Apparently our income is too much now to be eligible.  So I am responsible for 10% of the cost of the drug which comes out to $456.00 per month.  There is another program that I am going to try to get some help from and they are suppose to fax me a form.  I get that I should have to pay something, but $456.00 is a lot and I feel bad because my family can't do things that we would like to do.  Its hard enough having to deal with this cancer but to have to worry about how you are going to pay for everything is just too much some times.



#7 Trey

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Posted 25 May 2011 - 09:37 AM

Novartis has several  patents on Gleevec, but generally the main patent expires in 2015 (it  was extended from the original expiration date of 2013). It was granted  "orphan drug" status, meaning that it had a limited population that  would benefit, so patents are favorable to those companies that will  develop new drugs to fill these "orphan drug" needs.

Gleevec  was granted "orphan drug" status, meaning that it has a somewhat small  population that benefits. U.S. patent law is favorable to companies that  develop new drugs to fight rare diseases, granting extended patents. In  this case, the original patent was 17 years, and another 1.6 years was  later added (now Jan 4, 2015).  So there is no "generic Gleevec" allowed in the US and most countries.



#8 Beanie

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Posted 25 May 2011 - 09:53 AM

Trey, so do you feel that a generic form of Gleevec will be available in the U.S. shortly after January 4, 2015?  



#9 Trey

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Posted 25 May 2011 - 10:00 AM

Absolutely.



#10 hannibellemo

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Posted 25 May 2011 - 01:38 PM

Trey,

Will the fact that the vast majority of those with CML are responding to these drugs and living longer and longer lives even though the rate of diagnosis has not increased at some point remove CML from an "orphan" status?

Pat


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"You can't change the direction of the wind but you can adjust your sails."

DX 12/08; Gleevec 400mg; liver toxicity; Sprycel 100mg.; CCyR 4/10; MMR 8/10; Pleural Effusion 2/12; Sprycel 50mg. Maintaining MMR; 2/15 PCRU; 8/16 drifting in and out of undetected like a wave meeting the shore. Retired 12/23/2016! 18 months of PCRU, most recent at Mayo on 7/25/17 was negative at their new sensitivity reporting of 0.003.<p>


#11 Trey

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Posted 26 May 2011 - 09:13 AM

That could be possible in the future, but orphan drug legislation in most countries applies to the day it is patented.  US law defines orphan drugs as those which are meant to treat diseases with small populations, which is defined as fewer than 200,000 patients in the US.  The intent is to encourage drug development for rare diseases.  There are currently fewer than 100,000 CML patients.  At 4500 new cases per year it would take well over 20 years to have 200,000 patients with CML in the US.  A side question regards a drug which is developed to treat one disease but then is found to be effective against other not-so-rare diseases, such as Gleevec.  But that does not affect orphan drug status since the issue is development costs.



#12 hannibellemo

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Posted 26 May 2011 - 09:13 PM

Interesting, thanks!

Pat


Pat

 

"You can't change the direction of the wind but you can adjust your sails."

DX 12/08; Gleevec 400mg; liver toxicity; Sprycel 100mg.; CCyR 4/10; MMR 8/10; Pleural Effusion 2/12; Sprycel 50mg. Maintaining MMR; 2/15 PCRU; 8/16 drifting in and out of undetected like a wave meeting the shore. Retired 12/23/2016! 18 months of PCRU, most recent at Mayo on 7/25/17 was negative at their new sensitivity reporting of 0.003.<p>


#13 rickpister

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Posted 26 May 2011 - 10:32 PM

The generic for Sprycel is way out there.  No insurance = $8,000.00 a month.



#14 Trey

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Posted 27 May 2011 - 02:53 PM

When Bosutinib is approved (maybe 2011, certainly before end of 2012) I would bet Sprycel prices will drop significantly.  Bosutinib inhibits BCR-ABL and SRC just like Sprycel, but does not inhibit c-Kit or PDGRF as much as Sprycel.  That should mean similar good results with fewer negative side effects than Sprycel.  So Sprycel will have strong competition from Bosutinib.



#15 Susan61

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Posted 29 May 2011 - 07:16 PM

My question on Generic Gleevec is that possibly even though the cost would be cheaper that a lot of people may  not be able to take the Generic.  Just like other pills where people need Name Brand, as the Generics do not work as good for them.  Right now I am making it with my husbands insurance plan, but when he retires (God Willing That Gleevec is still doing its job for me) that we might not be able to afford either one.  



#16 Buzzm1

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Posted 29 May 2011 - 10:18 PM

The sooner, the better, for the Gleevec generic.

The price of Gleevec has increased substantially

in the 16 months since I first began taking it.

I priced Gleevec, through Kaiser, when I was first diagnosed,

at $3900 for a 30 day supply.

When I began taking it a few months later, it was $4600.

Now, it's $5162, through Kaiser.

Fortunately, except for a small co-pay, my insurance covers the cost of it,

however, since I'm on Medicare, the burden falls on the taxpayers.

Even though I greatly appreciate the availability of the drug,

Americans are at the mercy of Big Pharma, having to pay

top dollar for Rx drugs.

The U.S. with 5% of the world's population, consumes 65% of the world's drugs.

those percentages have held fairly constant for 40 years.

US Spending for prescription drugs was
$234.1 billion in 2008,
nearly 6 times the $40.3 billion spent in 1990
http://bit.ly/mLjjbT
$216.7 billion in 2006
$300.3 billion in 2009
$307.4 billion in 2010



For the benefit of yourself and others please add your CML history into your Signature

 

02/2010 Gleevec 400mg

2011 Two weakly positives, PCRU, weakly positive

2012 PCRU, PCRU, PCRU, PCRU

2013 PCRU, PCRU, PCRU, weakly positive

2014 PCRU, PCRU, PCRU, PCRU (12/07 began dose reduction w/each continuing PCRU)

2015 300, 250, 200, 150

2016 100, 50/100, 100, 10/17 TFR

2017 01/17 TFR, 04/18 TFR, 07/18 TFR 0.0012, 08/29 TFR 0.001, 10/17 TFR 0.000

2018 01/16 TFR 0.0004 ... next quarterly PCR 04/17

 

At the earliest opportunity, and whenever possible, lower your TKI dosage; TKIs are toxic drugs and the less we take longterm the better off we are going to be ... this is especially true for older adults.  

 

In hindsight I should have started my dosage reduction two years earlier; it might have helped minimize some of the longterm cumulative toxic effects of TKIs that I am beset with.  

 

longterm side-effects Peripheral Artery Disease - legs (it's a bitch); continuing shoulder problems, right elbow inflammation.   GFR and creatinine vastly improved after stopping Gleevec.

 

Cumulative Gleevec dosage estimated at 830 grams

 

Taking Gleevec 400mg an hour after my largest meal of the day helped eliminate the nausea that Gleevec is notorious for.  

 

Trey's CML BlogStopping - The OddsStop Studies - Discussion Forum Cessation Study

Big PhRMA - Medicare Status - Social Security Status - Deficit/Debt


#17 tomcal25

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Posted 03 October 2011 - 05:11 PM

Buzzn1,  What do you consider a small co-pay being on Medicare?  I'm turning 65 beginning of 2012 and have looked at the Medicare website for Part D prescription coverage. The cost is very high for a retired person, many thousands a year.  Maybe I'm looking in the wrong place or misunderstood.

Thanks ... Tom



#18 WoofWoof

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Posted 03 October 2011 - 06:58 PM

tomcal: I'm with you on the  "small" co-pay for Medicare. I'm in PA and the donut hole and monthly is very high. That's why we need a chemo parity law to take chemo drugs out of prescription plans and into medical health care. Contact your federal congress persons and urge them to support this.


I have cancer but it doesn't have me





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