Added generic Subutex

On October 8th, 2009, Roxane Laboratories announced the approval of an AB-rated generic medication for the popular opioid replacement therapy drug, Subutex®. The active ingredient in Subutex® is buprenorphine HCl. The more popular Suboxone, a similar medication by Reckitt Benckiser Pharmaceuticals, still has no generic equivalent.

2 mg Buprenorphine HCl
8 mg Buprenorphine HCl

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3 thoughts on “Added generic Subutex

  • ADMIN NOTE: This comment appears to be highly subjective. While we are not medical professionals, to date, we have not come across any scientific evidence that suggests buprenorphine leads to the type of problems listed in this comment.

    So sorry for your addiction problem! Here is the problem I have with pain specialists, regarding the Subutex issue… when someone gets off the use of heavy opiod pain killers, like Morphine Sulfate, at a high level –13 1/2 years of that for chronic pain–the manufacturers began to add binders to the Watco version of it, which that person was seriously allergic to…. then, began the pain specialist’s search for something that this patient was NOT allergic to…. and, after several months of allergic responses, trips to the emergency room, for anaphalactic shock, etc… and even more allergies to various other medications, it became a cold-turkey de-tox from a seriously high level of Morphine Sulfate, and Kadian, and Deladid–all of which that patient became allergic to all the binders that the DEA made them put into yhe generic versions of same! this presented serious problems for my friend, who had legitimate pain issues… the doctor (pain specialist,)-then put him on Subutex… (two days into the rapid, and cold turkey de-tox, from Morphine Sulfate, plus all the other stuff they tried …which could have stopped his heart!–Finally, Monday Morning arrived, and the pain specialist was able to take the edge off the Morphine de-tox and he was now, on the Subutex–he was finally able to stop shaking, having muscle cramps, throwing up,and having the runs… Now, around a year later–he was still on a small dose of Subutex (used, now as a maintenance dose)–and he was never told usthat it had “Opiods” in that medication… then, when the manufacturer stopped making it, the pain specialist (who was now trying to sell the generic to Medicare patients, at $15 per pill–the same price as the original version–to make more money for himself!!! (at the same price as real Subutex)–Now, the binders were embedded in that generic version, which promptly landed him in the ER. over the week-end… now, he is going through yet another painful detox… and now, may have some sort of clogged lymphatic system, over-loaded by the toxic nature of same… so, now, there is no solution for real chronic pain, and the patient went into a second painful de-tox ! doctors should not give patients “maintenance doses” of this toxic drug… and especially need to inform the patient that they are giving them a synthetic opiod, on which they can, and will become dependent on, just like the medications he just got off of!–Now, he is possibly looking at lymphoma, which was caused by the toxins in Subutex… running through his lymphatic system…and if you do take anything to slow that de-tox down? The stuff dumping into your intestinal tract, well, it simply burns a hole in your colon, that does not heal, and caused continual bleeding bright red blood, two and a half months later! the good news is–he is now off all pain meds.. but only functions, now, for two hours per day–to either sit, or stand up… so, what is this patient to do? Clearly this stuff is so toxic, that it can crash the lymphatic system, trying to get the toxins– out of your body~~~! It was good to get him off the morphine, but the subutex is just as bad… it is a bad drug, period !

  • Hello, I am a 2 year pharmacology doctorate student (student Pharmacist), and also, regrettably, opioid dependent lol. I just wanted to add a note on our topic here of the long-awaited generic approval of Buprenorphine HCl (Subutex): Not only has Roxane Laboratories approved and released a 2mg and 8mg generic formulation of Buprenorphine HCl to our pharmacies as of fall last year, but now Barr Pharmaceuticals, (recently acquired by Teva Pharmaceuticals), has also applied for, and received APPROVAL for their own generic of the same sublingual tablet formulation in the 2 and 8mg strengths as well!! :) Their application (FDA Ap # ANDA-090360), was submitted to the FDA around the same time Roxane’s was approved (October 2009), and was finally approved on the 7th of this month! (05/07/2010). We do not yet know when distribution to pharmacies will start but should be within the next 1-6 months. Now, some of you may be asking/thinking, “what’s the hell is the big deal about the SAME generic drug, just by another manufacturer?!?”. Well, the answer to that is, commonly, with generic drugs that have MULTIPLE manufacturers (such as prednisone, diazepam, hydrocodone/APAP, etc.), have varying prices from manufacturer to manufacturer, for the SAME drug, dose, and form. For instance, a bottle of 30 generic 20mg prednisone tabs of the Roxane generic may be $13.81, while a bottle of 30 generic 20mg prednisone tabs of the Teva may be $11.84. So, to some people, these differences in prices are ridiculously trivial, but to some others, such as myself who are broke as hell lol, it makes a difference and the savings add up, especially as the quantity increases. So the hope is, that since Barr/Teva Pharma. is generally a more cheaper manufacturer than Roxane, that the Barr/Teva version will be maybe a little cheaper. It may be by like 50 cents to one dollar USD cheaper than the Roxane for a given quantity, but hey, once again, that adds up, especially with large dispensing quantities. The only prob is SOME pharmacies only stock ONE generic version from one manufacturer only, for obvious shelf space reasons. Well, just wanted to fill anyone who may so be interested in the new approval for another generic. If you have any questions related to medications or the pharmacology or pharmacokinetics of these drugs, just ask :) Hopefully our dire situation(s) will get the greater attention and coverage amongst mainstream medicine and physicians that it deserves and hopefully physicians will stop just THROWING vicodin at everyone and stealing years of their lives from them. Well hope everyone gets their lives back..keep your head up and stand up and FIGHT withdrawal and addiction just as much as it’s fighting you!! May everyone have comfort and support in these times of need.. :) -C. Lombardi, R.Ph.

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