17 replies to this topic

[Beanie]

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?

[CallMeLucky]

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.

[MACELPatient]

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

[PhilB]

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

[Happycat]

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

[Beanie]

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.

[Trey]

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.

[Beanie]

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

[Trey]

Absolutely.

[hannibellemo]

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

[Trey]

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.

[hannibellemo]

Interesting, thanks!

Pat

[rickpister]

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

[Trey]

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.

[Susan61]

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.  

[Buzzm1]

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

[tomcal25]

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

[WoofWoof]

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.