Thanks to a reader for the following info about generic buprenorphine:

Good Morning Dr. J-
I just got off the phone with Roxane Labs, the only approved manufacturer of generic Subutex and the product IS available in all 50 states. It is available to pharmacies and dr offices direct from the manufacturer as well as from all major distributors. There is an ample supply available and is not on back order.

Opiate addicts taking Suboxone are hoping for a drop in price with the announcement of new generic medication from Roxane Pharmaceuticals
Opiate addicts taking Suboxone are hoping for a drop in price with the announcement of new generic medication from Roxane Pharmaceuticals

I called around to the major pharmacy chains and all three can order the drug (CVS, Walgreens, and Wal-Mart). None, at least in the Milwaukee area, keep it in stock because of its “orphan drug” status; however most can have it within 24 hours. (Only one of the pharmacists I spoke with actually offered to “pre-order” the drug before the rx was presented- the rest said because of security they do not order scheduled rx’s until the script is presented.
Also, anyone who has rx insurance and pays co-pays based on a drug’s status as generic or brand name (or a tiered system), the Roxane formulation WILL process as a generic. I did ask the drug rep at Roxane if they were also seeking approval for the generic formulation of Suboxone, but they said that it was confidential information, but that if they do it will be announced by the FDA if and when it is approved = YES THEY ARE…
I wanted to email this to you in case you wanted to share it on the Subox blog. And, the doc I attached is the drug info from Roxane.
Anyway this might all be old news, but I wanted to share it with you in case you wanted to pass it on to anyone~
Thanks very much, JP, for the info.  the PDF file he refers to can be found by clicking here.

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4 thoughts on “Thanks to a reader for the following info about generic buprenorphine:”

  1. I’m surprised that the FDA approved a generic Subutex without approving a generic Suboxone at the same time. When the two drugs were originally approved it was contingent on both medications being available simultaneously with Subutex mostly being used for in-office inductions and in a few special cases of adverse reaction to Suboxone or pregnant women.
    When the DEA rescheduled all buprenorphine products from schedule V to schedule III part of their reasoning was that they feared widespread misuse by injection, as was seen in some countries that only had Subutex. I don’t understand why suddenly that’s not important anymore. There has been very little abuse in the US when compared to countries that have Subutex as the major medication. It seems to me for the FDA to maintain consistent reasoning they should have delayed the approval of generic Subutex until a generic Suboxone was available. If generic Subutex ends up being much less expensive it will have negative impact abuse, which will prompt further regulation and restrict access to treatment.

  2. When I was first looking into the availability of generic formulations, I too was surprised that both products were not being launched at the same time. The manufacturer has said that producing generic Subutex is easier than producing the Suboxone- they are having difficulties combining the two active ingredients in Suboxone (buprenorphine and naloxone) into a sublingual tablet that works as well as the name brand version. FDA will not approve the generic formulation until they have developed a tablet that works- obviously Reckitt-Benckiser isn’t going to be providing any help to generic manufactuers in creating a tablet as it will simply continue to erode their market share…

  3. I live in Oregon. Tried to purchase generic at Costco and they said it did not exist. How would I go about informing? The copay on brand name for 30 tabs, was $60. The copay on generic would have been $20.
    How does the word get spread out to Oregon? Thanks, Diane

  4. they took the generic subutex off the market. Reckitt Benckiser just got a year extension on the patent. So no generic for subutex or suboxone for atleast one more year. They fought hard to keep that patent. It all comes down to greed. This company has had this drug over 15yrs making a killing off of the need of addicts. I think it is wrong but there is nothing we can do as the people (which i think is crap) becasuse it all comes down to money. Plus the goverment is not going to help because more than likely some politicians have stock in pharm companys. It shows were we are as a country. Obama passes a bill to were we will help pay for abortions in other country’s; so if we have the money to do that then why cant we help our own. My mom always said you can’t help somebody if you can’t help yourself. This drug suboxone saved my life. It is truely a helpful drug when it comes to addiction. It works the best but its the hardest to find and the most expensive. If you compare to methadone. I am a addict am found help in the suboxone program. At Target in my hometown of Florence South Carolina the generic subutex was 3 dollars a pill. But now it is off the market. I am glad also that i did not switch from suboxone to subutex because everyone i know who was on subutex says that suboxone last longer and just helps you out alot more.

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