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Julie  Stachowiak, Ph.D.

Generic Copaxone On The Way?

By June 21, 2011

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There have been rumors about generic Copaxone (glatiramer acetate) floating around for some time. This is a biggie, as Copaxone has almost 40% of the US MS market.

Here is what is happening right now (from what I can figure out):

Teva, the manufacturer of Copaxone, is trying to stop generic Copaxone from being produced and launched. Copaxone makes up about one-third of the company's profit. They have petitioned the US Food and Drug Administration (FDA) to stop the generics, claiming that any generic should have to be tested in a full clinical trial. That would take at least two years.

To stop generics, Teva filed a "Citizens Petition" with the FDA on December 12, 2010. It appears as thought the FDA has postponed their ruling on this petition (probably until September, according to some experts), although there have been some rumors that the FDA rejected the petition.

In addition, Teva has just launched a trial to test a double dose of Copaxone, which would be given three times a week, instead of every day. I am unsure (and can't figure out by reading the news) what this would mean for their patent.

Meanwhile, a company called Mylan is working the courts to file and defend its application to make generic Copaxone, possibly even before Teva's patent expires. Mylan has been sued by Teva, which is claiming patent infringement.

Teva's Copaxone patent expires in the US in 2014 and in Europe in 2015.

Anyone with any additional information or new developments on this issue, please post in the comment section below.

Comments
June 21, 2011 at 1:43 pm
(1) Bryan says:

Here’s a link to an article I stumbled across today about this. In short, the U.S. District Court for the Southern District of New York denied a summary judgment filed by Teva in an attempt to stop Mylan from producing their generic Copaxone.

Mylan wins on summary judgment

June 21, 2011 at 3:18 pm
(2) Nina says:

The FDA rejected Teva’s third citizens petition on June 8, 2011. The filing is posted here: http://www.regulations.gov/#!documentDetail;D=FDA-2010-P-0642-0008

June 22, 2011 at 10:07 am
(3) chris says:

Don’t get too excited about a generic Copaxone, it probably won’t happen anytime soon. Even if Teva loses the court case in September or the patent expires in 2014, the FDA could and probably will sit on a generic approval for some time due to the complexities of the drug. Look at Lovenox story for some clues, FDA sat on an approval for several years after patents ran out due to drugs complexity and Copaxone is more complicated than Lovenox.

A double dose could gain Teva a dosing patent but that would only mean a generic Copaxone (once approved) could only be dosed daily versus the branded Copaxone dosed 3x a week, assuming it is a concentrated formula.

June 23, 2011 at 7:36 am
(4) Sharon in Arkansas says:

What is going to mean to those of us using generic Copaxone? I was placed on it in December of 2011. No complaints, and very surprised about this article.

June 26, 2011 at 1:01 pm
(5) Todd says:

Sharon, are you getting this by Rx from a Neurologist? To the best of my knowledge, there is currently no generic form of Copaxone available. If you are ordering through a discount internet biz, beware! You may be injecting (God knows what) into your body. If it’s not taken by injection, it is not Copoxone (generic or brand name).

July 14, 2011 at 10:40 pm
(6) Nina says:

I am all for success and the spoils of that when it’s for the betterment of others, but one would think that by now Treva would have recouped their costs since 1996 when it was originally discovered by Professor Sela, Professor Arnon and Dr. Teitelbaum at the Weizmann Institute of Science in Israel. THEN, Teva was granted world-wide exclusive license for COPAXONE® and became the developer of the product.

When is enough greed enough? What, they ran our of scientists or good ideas? How sick capitalism can be when it turns into actions void of a conscience.

Then add the gvt bureaucracy with their greed to the mix in getting the generics out long after they are available; it’s a wonder anyone who ever gets sick actually lives no thanks to those two soulless groups.

July 23, 2011 at 8:31 am
(7) Vickie says:

Well said. You hit the nail on the head. I have MS myself and am currently not using a DMD. But I feel that rules are put in place for a reason. These companies that are making billions on the backs of those that have a disease that have few drug choices and then want to protect their product beyond the patent date are only in it for the wrong reasons. Come on. The government should realize it would be to their benefit for it to go generic. I’m sure they pay for a lot of it. Step in and bring the price down as the drugs go out of patent. Avonex goes out in 2013.

July 22, 2011 at 8:54 am
(8) mike says:

When I started copaxone 9 yrs. age, it cost $1250/mo. this was the cost of producing/distributing it and research and developement. Today the cost is a rediculous $3600/mo.- triple in just 9 yrs. And the dollar is NOT is NOT worth 1 third as much; and they stopped putting 30 cents worth of alcohol wipes in the kit. TEVA is an Israeli company and America is saving their ass by giving Israel billions of our tax dollars. There’s no limit on the cost of drugs since in the 1965 medicare law it’s specifically says that medicare CAN’T bargain with drug companies for lower prices like HMO’s and medicaid can, and nobody in congess will try to change it. Drug companies donate BIG to congressmen. WE THE PEOPLE (?sheeple) are just screwed.

August 13, 2011 at 9:02 am
(9) Delonghi esam 3500 says:

Hello,
thanks for the many helpful tips that you get here.
Just the class is there such a thing.
Mercy

August 13, 2011 at 9:03 am
(10) Verdopple deine Dates says:

Hi,
I can only confirm there will be a good help here.
You also get an answer very quickly here.

August 14, 2011 at 2:37 pm
(11) Aldaediselli says:

I am unable to get an answer to this question.
I was taking Copaxone once daily for 10 years.
I suddenly stopped the daily injections and had
a bad exacerbation after 4 weeks. I was in a rehab
hospital for 2 momths. Any connection between the
two…Just a coincidence?

December 23, 2011 at 12:10 pm
(12) mike says:

I was started on copaxone in 2004, cost $1250/mo. it has risen to $3600/mo. today, 300 % increase in 7 yrs. OUTRAGIOUS!!! The hell with patent laws. And, U.S. tax payers are paying billions to keep Israel where Teva is based still on the face of the earth. This is the thanks Teva gives us–a real good shafting. Merry Christmas

December 29, 2011 at 2:04 pm
(13) John Uelmen says:

My most recent copaxone bill was $4,722 before my insurance companys discount. After discounting it’s around $3,900 or so. Can anybody get an honest answer from TEVA? When I ttried to ask them for the reasons for the increase they had a person from shared sollutions contact me. They commented how the costs to make the drugs have gone up sharply. The physicians we’ve dealt with pretty much agree it shouldn’t be more than $10/shot. We’ve tried to find a better pharmacy with better pricing. Has anybody had any luck?

January 10, 2012 at 12:21 pm
(14) Theresa says:

I recv my copaxone from a small pharmacy called Adams Discount Pharmacy in eastern PA. They have always had the best prices on copaxone and other expensive meds I use.

Its weird when my insurance co calls trying to get me to move my script for copaxone to their specialty pharmacy, yet when I ask if they can give me a better price than Adams, they always say no. As long as I pay a percentage of the cost, Adams wins.

I do spend a day calling all local pharmacy’s early in year to competitive price shop.

I see it as a double edge sword, we are lucky to have something that seems to work, we are to afraid to stop it, and are desperate for anything to slow the progression, and we get screwed b/c of this. First we get a sucky disease, then we get screwed from the time of diagnosis and on. thats life.

February 2, 2012 at 12:16 am
(15) tom says:

i was diagnosed in 03. Went on avonex which caused deppression. 2 years ago switched to Copaxone. Not sure if deppression resloved because of wellbutrin or result of copaxone. Had 2 flairs in last 8 months and am considering Tysabri vs. gilenya. I dont like the odds on either. Dont like rate hike either. What a lousey way to make a buck.

April 7, 2012 at 7:12 pm
(16) Ed says:

In 2006/2007, Teva already launched a two years trial (FORTE study) to test a daily double dose of Copaxone. They stopped the study after one year since there was no difference between a daily single or double dose.

May 9, 2012 at 1:37 am
(17) Caillé says:

I read your comments about Copaxone with great interest. I am French and take Copaxone. In France, it costs “only” 800€ per month, which is less than 1000$. The conclusion is that … the costs of production have not increased for TEVA. They have the right to rise the price in the US and do not have them in France. The price even lowered from 900 to 800 recently here. I am appalled by the price in the US!

May 11, 2012 at 3:15 pm
(18) Caillé says:

In addition, I forgot to say that in France the distributor is Sanofi-Synthélabo not Teva directly. Who is the distributor in the States? who is making money: Teva or the american distributor if there is on? I hope this helps you to figure it out.

February 21, 2013 at 3:47 pm
(19) Amy Wilkins says:

My insurance just sky rocketed instead of 30 its 75.00 amonth. tier 2 . These companies are ripping people off on the copaxone. The USA needs to step in.

January 27, 2014 at 12:07 pm
(20) Maureen says:

Glad to see these comments. The price is now almost 5000 per month (2014) Gone up from 1100 per month in 2001. RIPOFF Drugs are supposed to get cheaper over time as companies recoup their development costs. Competition needed! Generic is needed badly! I hear now it is coming this year….how much will it cost I wonder?

March 26, 2014 at 9:05 am
(21) Mary Ann says:

Hi all! Right now I am having a relaspe. I am taking the daily dose of Copaxone, and went to my Dr. To find out that Copaxone is now 3 times a week. I have been shocked when Caremark, (Medicare) called me and told me the price of $2500 in the donut hole! Who can pay these redicilous prices?! It makes me sicker! Now, I want to know if I can get the daily dose which I have been doing since 2006. Would the daily dose still be available, and if so would it be cheeper? Who cares if it is 3 times a week. I honestly cannot afford to be taking this medication. So do I give up feeding my family? Cloth them? And give them a roof to sleep under? Someone help, please?

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