Generic Imitrex approved by the FDA

GSK has tentatively lost patent protection on two of its popular drugs: Coreg and Imitrex. Imitrex is the more profitable of the two, with 2004 sales of $1.1 billion in the US, but the loss of Coreg is substantial as well. Together the two had combined sales of almost $2 billion in 2004. 2005’s were even more impressive: $1.4 billion in the US and over $2.42 billion globally for Coreg. The announcement of the FDA’s approval of Mylan’s generic sumatriptan comes hot on the heels of Imigran (the UK name for Imitrex) going over-the-counter in that country in an effort to retain some of its sales.

Mylan will now have a mandatory 180 day monopoly on the sale of three strengths of Imitrex: 50mg, 100mg, and 150mg tablet forms thanks to the Hatch-Waxman Act that I’ve talked about before, provided GSK doesn’t pay them to not sell it so they can extend their effective patent life by another 6 months, which is certainly a possibility. Injectable and intranasal forms of Imitrex remain covered by patent, and I don’t think we’ll see Imitrex tablets going OTC in this country anytime soon.

[tags]Imitrex, GSK, Sumatriptan, medicine, pharmacy, Coreg, carvedilol[/tags]

143 thoughts on “Generic Imitrex approved by the FDA

  1. thanks SO MUCH for the info and link on inhousepharmacy.com. i just ordered imigran 50mg at about 5.15/dose when i was paying $21/dose for imitrex in the US. i hope it works because my wife takes 1 a day and at $21/dose that’s $155/month vs. $630/month.

    this looks to be an illegal practice from what i can tell but i don’t care. freaking catch me if you can, FDA.

  2. Thanks for all the info on migraines and Imitrex. I went to Mexico summer of 2007, some little town right inside the border near Anrade, California, near Yuma, AZ. http://gosw.about.com/od/southwestmiscellaneous/a/Algodones.htm
    Right after you enter Mexico on the left set back from the main road is Mary’s Pharmacy. My friend has used this one often with her parents.
    I purchased Imitrex (sumatriptan) 100 mg. for around $3 per pill. The first price they gave me was more, but I haggled a bit. I used the medication all summer and it worked just the same as the stuff I get from the states. I was thrilled. Now, of course, I am out and need to get more. I just don’t live on the west coast! Hope this helps some other migrainer suffers.
    Also, I am presently trying hormone therapy to reduce my migraines. I have friends who have had great success with this. I’ve just started, so we will see!

  3. Here’s the deal people… Drug companies pay ALOT in research and development of what they percieve to be profitable meds. You suffer from migraines which are debilitating but not life threatening, so it’s a quality of life drug. You could suffer as I did do for 10 years before getting out of the military and finding a doctor who actually listened to my symptoms. As long as you choose to pay whatever they charge…. they will charge whatever they can during their approximately ten year protection til generics come out then the price will drop all over the place. I made it ten years and now that my insurance no longer covers imitrex, at 20 bucks a pill I can’t afford it, so I guess waiting til next year is not a big deal. I barely function without them some days but the kids gotta eat, thank god the generic will be here next year and don’t blame Imitrex, their job is to make money and you can CHOOSE not to buy their drug, your life is not at risk, just your comfort.

  4. I have suggested this before.. and it’s the best I can do…I order from http://www.Inhousepharmacy.com – non-generic..the real thing: Imigran..approximately $6.00 – 50 mg. I take it with an Alleve , cut it in half, and rarely need more. I have learned to listen to the very first signs of a migraine coming…

    I order only one box at a time..(16 tablets for 72.00 (now 69 with my repeat discount) They do not give a discount for larger orders… but a $3.00 discount for repeat bsns, and no shipping charge.

  5. Please keep me informed of any changes and/or helpful information regarding generic Imitrex. I just had a terrible weekend of migraine pain. I use 100mg Imitrex and am tired of paying the high price. I am going to order from inhousepharmacy and try it. Thanks for the information

  6. 100 mg of Imitrex is a high dosage. Have you tried using less and combining it with Aleve or Excedrin? I have never found that Imitrex alone did anything. In fact, the new version of Imitrex is going to be in combination with Aleve. Apparently, GSK also has realized that Imitrex alone doesn’t do much to relieve pain, so they will be adding a painkiller. We don’t need them to give us a new variety of medication when we can combine them ourselves. As I have said before I have found that the generic Imitrex from Canada (100 mg cut in half) is reasonably priced and works just as well as the real thing.

  7. The issue of the outrageous price for Imitrex will be the bane off all of our existence until it finally is pronounced, “generic”!

    I haven’t posted here for some time because I had started the Migraine Program. I’ve written about it before here, it’s a cure not a single drug or blanket technique.

    The Program is presented through a website, very user friendly, but detailed and sophisticated site. http://www.migraineprogram.com. I have now been on it for a year. I started with 45 years of mind blowing migraines, 20 to 30 per month. Now disabled and on Social Security I’ve tried everything I could find for some hopeful help in anyway. It’s worth a look at the website for anyone who writes on this site. It is based on nutritional supplements and bio-identical hormones and it works! It really works! I’m now down to 4 per month and so many other illnesses have improved its amazing.

    Yes, I still need the Imitrex. But instead of 100 mg I use 50mg and the migraines are much smaller and go away quickly instead of 4 to 6 hours. Yes I still need the Imitrex, but the last script I purchased was last December!

    I’m not selling anything, I just want to stand on the tallest building and scream that a brilliant Dr. has found the key to save us. They ask for a special series of blood tests and for you to fill out a very detailed life medical history. From there they create a plan specifically for you. It does cosst $2000 to start for 3 months, but you have them available to you constantly. You stay in touch and they keep refining it until they find the total solution.

    I was on 8 scripts when I started. I’m only on the occasional Imitrex now. My cholesterol went down, my hot flashes are gone, my arthritis is almost all gone, I’m off my bi-weekly allergy shots and meds that I’ve been on since I was seven years old, I had fibrous lumps in my breast and they are gone. My digestion is “Normal for the first time in many years. I’m sleeping and the “fear” from the impossibility of a migraine is gone.

    I have nothing to gain from writing this because I have already benefited so much…because of these wonderful people I have my life back. I just wish for you to check it out…there really is a solution.

    I have met several people on the program and they are all doing great and each of their programs is totally different because they are so well designed for each of us individually. The most amazing thing is that they are there for you. I needed help one really rough night getting off a narcotic and I reached the doctor on a Sunday night while he was at a conference giving a speech! That’s the exception to the rule, but even though it’s through the internet there are wonderful, available people behind it.

    Under Audio testimonials on the website I’ve left my story and it’s several months old. Check it out and those of some others, you owe it to yourselves. Then hopefully we won’t care about Imitrex ever again!

    P.S. I’m eating chocolate again after none for over 10 years, just the icing on the cake so to speak!!!

  8. I read earlier this year that the generic form of Imitrex will be out the 4th quarter of this year (2008). What will it be called and is it going to be available here in the United States?

  9. I’ve been buying sumaptriptan online for years. from Canada or India, depending on price and brand. It either comes from England, or France, or the generic by SunPharma in India. My doctors have no trouble providing prescriptions for these. I’ve had no problem with the meds, and no problem with the mail. If I had to depend on Imitrex in the US, there is no way I could afford it. If our government and phamrm. companies really try to shut this down, they will have a big fight on their hands.

  10. RJS, who do you work for? Lobbyist? Lawmaker?
    You sound like a paid apologist for BigPharma.

  11. None of the above.

    But I do have a basic idea of how the patent system works, and why it was created. If it didn’t exist, you wouldn’t have Imitrex at all. I know, that probably boggles your little mind.

    Maybe you ought to look into the whys and hows of patents before shooting your mouth off like an idiot. I’ll give you the short version: patents foster innovation.

    http://digital-law-online.info/lpdi1.0/treatise53.html
    http://people.howstuffworks.com/patent2.htm
    http://www.ftc.gov/opp/intellect/020226bronwynhhall.pdf

  12. yes, inhouse pharmacy no prescription. “imigran” is the EXACT same formula as imitrex. it works exactly the same and costs $5.15 per pill.

    yes patents foster innovation but the market finds alternatives when the price is prohibitive.

  13. The truth of the matter is that drug companies almost never pay for research and development of new drugs… It’s a big lie! Most worthwhile breakthrough drugs have been developed in government labs or universities at tax-payer expense. The drug company pays almost nothing for the patents and reap billions off other peoples hard work. Any research they do themselves, is in derivative drugs (drugs that already exsist) and the main goal is to figure out how to re-market them for new made up aliments making billions more. And how does all this happen? Drug company lobbyists, toothless FDA, and spineless politicians giving them what they want.

  14. I too suffer from migranes. I cut my tablets in half to survive. I know there is a safe website pharmacy you have listed from the UK. Is there a SAFE website pharmacy in Canada that I can use?

  15. Look for friends traveling … Bought Imigran all over Italy for about 7 .00 US a tablet… 50 mg, and in Columbia for 6 or 7.00- US .for a 100 mg tablet generic..worked fine.and I cut them all…no trouble.. But still ordereing from Uk…Inhousepharmacy.com

    Great prices, no prescrition needed. and non generic.Imigran by GSK, 72.00, 16 tablets 50 mg.

  16. I am just so frustrated as the rest of you. I did wonder if all of you know about Migravent. It contains, magnesium,riboflavin, feverfew, and butterspur(butterspur is only sold in UK). I have been taking it about a year and my migraines are lessened by 85 per cent. Our scientific literature has substantiated the first few to decrease migraines, but only now do they allow adding butterspur. You get it by going to http://www.migravent.com and it is about $32. a bottle. I found it difficult to get used to. That is probably because of the large amounts of substance in it, so start only 1 pill a day and if you can stay 1 per day would be good. The adjustment time was difficult for me because it is also alterating brain function. I would get dizzy, disoriented at night and drowsy. It was worth it to relieve the migraines to only a few a month and those were from walking 2 miles. It took several weeks to get used to it, but it was worth it. I did learn about it through a Neurologist office, not by him, but through staff. Good luck and if any of you find a generic source of imitrex in this country, let me know. I need to walk to keep my stamina, but can’t without a migraine med.
    Jeanine K. Nehrling

    http://www.migravent.com
    http://www.migravent.com

  17. My wife suffers from very severe (3-5 days long) migraines, but fortunately they are also very sporadic maybe 3-4 times a year. After trying just about everything in the market Imitrex finally kind of did the trick not completely curing it but making it much bearable. Lately she has been taking the first dose with 500mg of naproxen and this seems to work much better than just the Imitrex. Today she got a migrane and I noticed that she was out of medication so I called our local CVS farmacy and when I picked it up; much to my surprise they only charged me $15.00 for my deductible. When I got home I realized that they had dispensed a Dr. Reddy’s brand generic equivalent. I went to the internet and found tons of articles realed to the release of generic Imitrex in the US. though I don’t know the actual cost of the entire prescription I am pretty sure that is a lot chaper than the GSK original. I certainly hope that this bit can help some of you and I also hope that is cheaper and easier than to have to order from abroad. good luck to all.

  18. Today I paid cash $140 for nine 100 mg. tabs at Costco. Previously, they had been charging $220. I don’t think they are the generic, however. But, my greatest help has come from taking Topamax (sp) daily. I used to have headaches quite frequently and now have them much less often and with much less severity. When I first started taking the Imitrex it worked 50 mg. very well, then over time I had to take more and was increased to 100 mg. I learned about “rebound” headaches and I believe that’s what happened to me, but the Topamax has helped me reduce my imitrex intake and I think that got me out of that cycle. I don’t know if it’s the same, but it seems alot like a caffiene withdrawal, only much worse. I hope this helps someone.
    Dave

  19. Has anyone ever bought from the Med Store.. an on line pharmacy? They are cheaper than inhouse for the Imitrex..but it is a generic… 50 mg , 30 tablets for 138.08. No shipping cost over 149.00 . I compared all my meds, and some are less, some more. especially important when I reach the donut with my pharmaceutical plan. and Yes, CVS can get the generic Dr Reddy imitrex, but my plan didn’t have it listed ..YET!! CVS quoted me 120.00 for 9 tablets. 50 mg. retail.. Don’t know what it will be when my plan kicks in..

  20. By the way, i had horrible reactions to Topomax..(as did my neice) .. so, be aware of just not feeling well..if you start it…I wasn’t and didnt know what hit me for days after the symptoms started.

    I will probably not buy the new version of Imitrex.. I just take an Aleve with it.. Most importatn for me is to catch it right away..not wait to see if it “goes away by itself..or try something else first.. “..

  21. I had horrible reactions to Topomax too. I depended on Imitex too and now take it once in a while, I still have frequent migraines but I try to use Midrin or Epidrin or anything I can to avoid the Imitex. The reason…It causes major rebounds!!!! If I take it for every headache, I’ll have a headache everyday. I’m telling you, if you are taking it every day you should suffer through a few and see if you can bring down the number of pills needed. At $20 per day it was killing me. I know it’s hard but it worked for me. I get a migraine once sometimes twice a week, but if I take the imitex at every start of a headache my body becomes completely dependant, they work so well and put me in a state of bliss!!! I guess if I was getting them cheap enough I’d take them often too, don’t get me wrong.

    Here’s another funny thing I was at my neorogist today and she swears that generic imetrex is available she says it’s called Sumatriptan and then I call Costco and they say “people keep calling us and asking for that but we can’t get it it’s not available from our supplier.” I’m confused! I guess I’ll try CVS?

  22. I have read this forum since the “Get-Go” and have participated in some discussions, It has been stated numerous times about getting Generic Imitrex (sumatripan) from in house pharmacy ( Thanks Bobbi), price is approx $5 per 50mg tab, I’ve ordered from them several times–I don’t understand being in a state of “Bliss” by your comment Shawna, I’ll tell you what bliss is, I am child of the 60’s and I’ve done some stuff that is “Bliss” but Imetrix ain’t one, When my migraines start and they usually last for 3 days,To break the cycle I do 50mg Benadryl and go to bed–

  23. Hi Everyone, I found this forum while googling a release date for imitrex generic– to everyone GREAT JOB FOR ALL YOUR COMMENTS & INFORMATION. All I have to offer is the following: I’ve suffered from migraines for approximately 11 years– the best advice I can give is to try to find an anaphylicatic drug, such as an antihypertensive drug to take every day to hopefully minimize the frequency and severity of the migraines. Ever since taking Inderal(Brand Name) or propranolol(generic equivalent) as well as naproxen sodium daily I did find a great relief in the frequency and severity. When I get a migraine now it’s a walk in the park. When I do get migraines I take a combination of 50mg imitrex and 2 Fioricet(Brand name) or Butalbital/Acetaminophen/Caffeine(generic equivalent) and my migraines are usually gone in 15-40 minutes. Of course I realize that what works for me is not going to be a cure-all, but for some of you this may help. I made my husband a believer when he asked his doctor for a similar combination– instead of Fioricet, he takes Fiorinal (Butalbital/Aspirin/Caffeine). And when it’s a killer migraine, I occassionally take the imitrex nasal spray. Just my 5 cents worth. I think most of the forum users are having an issue with the cost– so I’ll just say that both Fiorinal and Fioricet have generics and they are dirt cheap. I don’t have any affiliations to any pharmaceutical companies, and I too hate to pay the $40 a month and sympathize with everyone for the enormous sacrifices everyone makes in order to function everyday– and try to be “normal” like everyone else. I too, ask my doctor for samples when I see him annually and he usually coughs up 5-6 tablets, which is wonderful.

    On a different issue– pill splitting, I’d like to say that every drug has different inactive ingredients for various reasons, and in the case of Imitrex, the coating is to protect it from the stomach acid in order to maximize absorption– most of the drug is excreted, so there’s where the pink coating comes into place. However, I too, cut my 100mg tablets, yes they’re uneven, but I save the smallest ones for less severe migraines and that works for me. I too like to save money, and I’ve been doing it for almost 4 years, and haven’t seen a change in efficacy. Good Luck & Happy Holidays to Everyone! May the new year bring fewer headaches and a generic Imitrex generic!

  24. For pill cutting, I hope you are all use the pill cutter at the drug store.. I only found it recently.. and store my extra half in it in my purse. cuts it quite equally.

  25. Hey Great News!!!!!!!
    Yesterday, I was able to buy Dr Reddy’s sumatriptan succinate, which is generic Imitrex! I received 10 pills, 100 mg each, for $20.00 at Community Pharmacy in Bucksport, Maine. If they can get it, so can any other pharmacy, but the phone no there is as follows” 207-469-7030. I did tell them it was available in generic form, after reading it here, and they know I have been looking for it. Thank you to the person sharing the info about Dr. Reddy’s generic immitrex. I am thrilled!!!
    Jeanine Nehrling

  26. Jeanine, Was the Sumatriptan price you quote for the Dr Reddy generic the price of your insurance co-pay, or their retail, anyone can walk in the door price? SOme insurance providers have it listed, and some don’t have it yet. thanks, bobbi

  27. Bobbie!
    Yes, the $20.00 was the co-pay and I did have a prescription for 100 mg Immitrex and it was filled through the pharmacy and not available just off the shelves I don’t think. I have been refusing to pick up medicine at $50.00 for 9 tabs and I have a number of refills I can get filled, don’t know if more than 10 could be picked up for that co-pay, but I will check it out!

  28. My meds goes thru medco, and I talked to them today- I am covered. They have generic! I will mail order, but it will cost 35.00 if I buy one month at the drugstore.
    (for 9 100mg tablets) yea! I split them in half of course..

  29. To all!
    I spoke with the pharmacist here at Bucksport Community Pharmacy and she told me, generic immitrex had become available on her wholesale order form and she ordered it. Should be available if you keep checking with pharmacies. I still do not know if I can get more than 10 on my $20.00 copay.

    This is the best Christmas present I could receive and I hope some of the rest of you will be successful soon! Merry Christmas to all and a new year of less headaches!
    Jeanine

  30. Jeanine, Thanks for the follow – up.. I have enough for a month or two…wonder if the out of county generics will reduce in price to compete, since we can now obtain them right here.. Guess time will tell.. We who are on medicare have to watch our med nsurance not to go into our “bubble” too quickly, so that even though the co-pay is small, the amount that they consider “retail” is counted up until you reach a certain level, and then I have to pay out of pocket the next 2500.00.or so.. .. It is just a game you have to play…just wait, you young’uns..I will call Human later in the month to see what they are offering as a co pay for the immitrex.. bobbi

  31. Hi Bobbi! I’d love to know who you have your Medicare part “D” insurance with? Mine has an amount of $4800 for out of pocket in the donut hole for 2009!

    Yesterday I attempted to fill a script for generic imitrex with no success! My insurance company insists that “since there is only one company making it, that the copay is still for a “Brand name” drug!” I asked my pharmacist what it would cost me for 18 pills of 100 ml not on insurance and was quoted $220.00.

    If your insurance really has a donut hole of $2500. I need to know fast please! And have any of you run into this situation of being charged for a Brand name even though it’s generic?

    Many thanks,
    Ellen

  32. ..AFTER MUCH RESEARCH, I AM CONTINUING TO USE HUMANA FOR MY PRESCRIPTIONS… I HVE NO DEDUCTIBLE THIS TIME, AND I WIL BE CAREFUL NOT TO GET TO MY DONUT.. WHICH IS 2500… NO CHARGE FOR GENERIC ANITIBIOTICS.. BUT I WILL BE CAREFUL TO KEEP TRACK OF THEIR RETAI… I’LL LET YOU KNOW HOW IT GOES.. IF A FRINED IS GOIN G OUT OF THE OCUNTRY AND CAN GET THE GENERIC CHEAPLY, I WILL USE IT.. OR EVEN IF MY OVERSEAS CONNECTION IS REASONALBE ENOUGH OT KEEP ME AWAY FROM GETTING INTO THE DONUT.. WE’LL see if i can play the game….bobbi

  33. Thank you Jeanine and Bobbie! I’m going to check both insurance companies out fast! I almost fainted when I saw that my donut hole was $4800! I would have thought since it is a government program that the donut holes were all the same…no way!

    Good luck Bobbie playing the game! Last year the donut hole almost killed me! They tell you that what you contribute up to whatever amount gets you to the donut hole. No one tells you that it’s not what you contribute but the full retail price of everything you’ve gotten!!!! I think it’s a crime and I pray that President Obama is going to do something about this too!
    I have to say, as I did months ago, that the Migraine Program, now called The Dzugan Method, after the amazing doctor who is responsible for it, http://www.dzugan.com, has made it so that I’ve had much fewer migraines and didn’t hit the donut hole this year!!!! It isn’t cheap, but it works and heals a lot of other ailments too and is definitely cheaper than hitting that donut hole! Check it out and thanks again!

  34. I heard (and have read) the generics went Thusday. I’ve yet to confirm…check with your damn doctor.. or pharmasist… or my mamma… I don’t know. Sing if you know, please.

  35. I can confirm the generics are here. Received my 3 mo supply (27 tablets, 100 mg) of Dr. Reddy’s Sumatriptan Succinate today – $20 from Caremark (CVS Online Pharmacy).

  36. Kerry,

    This from the FDA Office of Generic Drugs (full content can be found at http://www.fda.gov/cder/ogd/)

    A generic drug is identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price. According to the Congressional Budget Office, generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies. Even more billions are saved when hospitals use generics.

    Health professionals and consumers can be assured that FDA approved generic drugs have met the same rigid standards as the innovator drug. To gain FDA approval, a generic drug must:

    – contain the same active ingredients as the innovator drug(inactive ingredients may vary)
    – be identical in strength, dosage form, and route of administration
    – have the same use indications
    – be bioequivalent
    – meet the same batch requirements for identity, strength, purity, and quality
    – be manufactured under the same strict standards of FDA’s good manufacturing practice regulations required for innovator products

    Long story short, they work for me, and the side effects seem to remain the same for me, i.e.; entire body muscle pain and a weird smell or sensation for a brief time before the headache starts to diminish. The side effects are more pronounced with 100mg (especially the muscle pain), so I try to get by with 50mg, which usually work.

    Checked out your link and maybe some are having a placebo effect in reverse, if such a thing is even possible. I know that when I was given a capsule instead of a regular pressed pill of a mild barbiturate (butalbital) that I take sometimes, it didn’t seem to work the same as the regular pill and I had them replaced. Maybe just personal my preference.

    Not being a medical professional I can’t address whether inactive ingredients interact differently with the main components of the drug.

  37. Kerry!
    I have only used a few and I did wonder if they were as strong of the original imitrex. It could be, two could be necessary. I waited it out and took other analgesics and the headache went away.

    There is another generic med that I know unequivacally that it is not as strong as the original med. It works, but you need more.
    Jeanine

  38. After ordering a refill of my Imitrex I was surprised to receive the generic – Dr. Reddy’s. I haven’t used it yet as I still have some of the “real” Imitrex left. My concern is that the package says it is made in Singapore. I know the active ingredients have to be the same as Imitrex but I am concerned about the inactive ingredients. With the rat poison in pet food a while back and melamine in infant formula this past year, it has me a litte worried. I’d be interested to read what any others have to say about the generic – was it as effective or did you have any side effects different from Imitrex?

  39. I Discussed the generic imitrex with the pharmacist and she looked at the package and it is produced at the same place the Glaxo-Smith-Kline imitrex is produced suggesting that this Dr. Reddy’s sumatriptan succinate is the same as the original imitrex that has been on the market 10-15 years.

  40. FYI: I haven’t checked this recently, but I did read the whole disclosure sheet on Imitrex several years ago. It indicated that GSK’s studies did not show any greater effectiveness in using a 100 mg dose instead of 50 mg. That is the basis on which I have obtained 100s from my MD and cut them in half, contrary to GSK’s recommendation not to cut them.

    I have been using Imitrex for well over 10 years, and am delighted that it is finally off-patent.

    Another point of interest is that I required on-average 3 Imitrex per week until about a year ago. I studied and plotted this for many years. But now my headache frequency is approx. one per month. I have no explanation for this twelve-fold reduction of headache frequency. I am 68 years old. Maybe your headaches will also remit when you hit 67.

  41. I just got off the phone with Prime Pharmaceuticals. They claim that the generic version of Imitrex is not approved by Medicare so it is not included in their formulary. Her explanation was that it is approved for sale in the US but is not approved as a generic equivalent to Imitrex. Figure that one out. Does anyone know how to handle this?

  42. I got the generic Imitrex (Dr. Reddy’s) at my local Safeway Pharmacy. Seems to work the same as the original.

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