8 replies to this topic

[pamsouth]

I went to see my Oncologist last week and he asked, if I knew that Gleevec would become Generic in 2013?  

I told him I heard 2015, he said he heard 2013.

I would think since he works at Indiana University Simon Cancer Center, as a Leukemia specialist, he would be informed.

PamSouth

[Susan61]

Hi Pam:  I was just talking about that to my husband tonight, as we were discussing what all our medications are costing us even with co-pays and insurance.  I said I thought I heard 2013 or 2014.  I do not think there is anything definite yet, but maybe someone else would know.  Hope your doing good.

Susan

[GerryL]

Hi Pam,

On the USPTO.gov site http://www.uspto.gov...s/terms/156.jsp it says that it was originally set for 28 May 2013, but an extension was put in for the patent taking it up to 04 Jan 2015.

[Trey]

Just to expand the discussion, Novartis has several patents on Gleevec, but generally the main U.S. patent expires in 2015 (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, granting extended patents. In this case, the original patent was 17 years, and another 1.6 years was later added (now Jan 4, 2015).

From what I can find, the patent for Gleevec in Canada expires April 1, 2013, so it is unclear how the rest of the world will treat the U.S. patent in view of this.  It will be illegal to import any generic Gleevec into the U.S. until 2015.

See following link page 29:
https://docs.google....JrxjsS5FTJ0GKNA

There is a "method of use" patent on Gleevec covering treatment of GIST tumors that does not expire until June 2022.  The implications for GIST patients between 2015 and 2022 are unclear since generic drugs will be available in the U.S. before the 2022 expiration date, but apparently not for GIST tumor treatment.

http://patft.uspto.g...5&RS=PN/6958335

[pamsouth]

Gerry,

Your link to USPTO.GOV  The United States Patent & trades.  I searched for Gleevec and this came up.  I didn't see a date the article came out.

Patent Terms Extended Under 35 USC §156 - United States Patent ...

"GLEEVEC : 28-May-13: 586 days : 04-Jan 15: 5,521,207:   I assume that means it was extended to Jan 4th, 2015.

I will have to check out Trey's article too. 

PamSouth

[pamsouth]

Trey,

This article looks like it pertains to Canada only.  Gleevec to expire April 1, 2013.  That will be very interesting.  I wonder how many CML Patients, in the U.S. who can not afford the Gleevec, will be finding a way to get Gleevec from Canada?

PamSouth

[hannibellemo]

Hi, all,

I believe the terminology is that Gleevec will go "off patent" in 2015. Whether or not a generic version is ready to go on January 4, 2015 remains to be seen. No generic, no price break. I certainly hope so for everyone on Gleevec but I have also heard that there are some issues with the biological equivalents.. Has anyone else heard anything?

Pat

[pamsouth]

HI Susan, 

Everything about the same here. 

Labs Sept 19, 2012 -  FISH AT 5% AND PCR AT 6.09 %.

June 2012, -  Fish 6.5% and PCR 8.4 %.

March 2012,  - Fish 1.5% and PCR 7.623 %.

CBC, CMP,  good,  glucose was a little high 114, but then it jumps around between 85 to 120.  Probably should have fasted.

Kidneys's about the same, GFR EST MDRD 60,  GFR COCKROFT GAULT EST 57 LOW, Would like for them to be a little higher.  <60 puts me in chronic stage., so I am border line there, sort of jumps up and down a little.

Creatine .86 normal.  Bun 13 normal. Everything else normal. WBC 6.2, RBC 4.05, HGB 12.7 Platelet 415, Differential granulyctes in normal range.

All of the above labs were done at Indiana University Simon Cancer Center.   Indiana University is a school of medicine where they have students from all over the world come to study and do their internship.  The cancer center  is in  busy downtown Indianapolis. I have to pay to park, but it is only 15 miles from my home.   I believe they are the only ones in Indiana that actually do the FISH & PCR in house.  I don't know why he, the oncologist keeps ordering the  PCR since my FISH is positive.  I asked the nurse if the onc would not do the PCR, as it cost the insurance over $3000,00 but I guess he still wanted it.

Doc was kind of upset with me in that he wanted me to have labs and see him, ever two months, instead of three months, because he says I am in a small window.  Wonder why he doesn't have me do a monthly CBC??  Kind of strange as I have only done labs every three months for about the last 6 years.   My previous oncologist had me do a CBC ever month for about 5 1/2 years, then every two months last year.   The oncologist nurse said Pam, if you want just call me and I will fax a script to wherever you want to go to get your labs, I think she meant CBC, I don't know.  I said I can do that, she said sure, we got people who travel from afar and have their labs done  where they live.  I am thinking the labs must be sent UPS to IU for the FISH AND PCR.  Anyhow the onc, looked up at the nurse and was irritated, he said a big fat "NO" I want all her labs done here, she doesn't live that far away, and she is my patient.  Dang He jumped down the nurse's throat for mentioning it.  I don't know what is up with that.  Except I am wondering, if he is so worried that I am in a small window  (have been for a long time)  why doesn't he just let me go to a lab close by my home, and have a monthly CBC, instead of charging  the insurance $3,000.00 to $4,000.00 for FISH and PCR every two months.  I mean my FISH has pretty much been between negative and 8% for 7 years. Anyhow my next lab is scheduled for Dec, 3 months from my last labs.

Part of the reason I don't do more then every three months is, I have enough trouble with getting my insurance to pay, and since my labs have been stable for several years, I didn't want to push the insurance and be stuck with paying thousands of dollars.  I still don't think he needs to run the PCR period, unless the FISH is a stable negative "0".

I mentioned my Medicare would be effective Dec 1, 2012 and I needed to call to find out how that works.  Onc said he doesn't know anything about insurance.  Nurse said we have older people on Medicare that come here.  However I got some literature from Medicare and our UAW benefits.  It looks like if I have my labs done in Dec I would have to pay my deductibles, and then pay them again in January when I go for my oncology appointment.  That's kind of stupid.  So I think I will call Medicare to make sure I understand and push my lab and onc visit both into Jan.  That will probably upset the oncologist, he already lectured me about not coming every two months, I said NO, because of my insurance.   He has sort of got a short fuse.  I took 2 lorazepam before I went to my appointment and didn't say much to him, he did most all the talking.  In fact he asked me if I knew that Gleevec would be generic 2012.   When he got upset about me not coming every two months, I just repeat myself, I don't think insurance will pay for it because my labs have been the same for quite a few years, including here at Indiana University. Yep  every time he goes over the same issue, I just repeat....  and they say women are bad about repeating, I wondering why does he not hear?

All in All, the appointment really didn't go that bad, he just tells me one thing, and I do another, he is not the one who has to pay the bills, and he could have me do a monthly CBC.  I did push the issue, every 3 months, he seemed to be irritable.   Again I don't understand if he is so concerned why he just doesn't have me do a monthly CBC locally.

PamSouth

[GerryL]

Hi Pan,

The Certificate extending the patent is dated May 28 1996 http://www.uspto.gov...rts/5521184.pdf