Androgel now available as a generic

Discussion in 'Men's Health Forum' started by mranak, Feb 12, 2006.

  1. #1

    mranak Junior Member

    Watson Pharmaceuticals Receives FDA Approval for Testosterone Gel Product

    testosterone gel 1% CIII is the generic equivalent to Solvay Pharmaceutical's androgel(R), which is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.

    Assuming that this product really is equivalent to Androgel, this seems like good news to me. When Solvay purchased the rights for Androgel from Unimed Pharmaceuticals Inc, they increased the cost by 400%.

    That potentially bad part to this is that it reduces the incentive for Solvay to fund new clinical studies for Androgel. However, I am well aware that Solvay is currently funding a clinical trial of Androgel for hypogonadal men with diabetes, so perhaps we are okay on that front.

    I look at testosterone cypionate, for which the package insert still says q2w-q4w, and I realize that the drug companies aren't actively promoting a drug that is available as a generic.

    One thing I wonder about is: what would the generic for Testim be called? The website for Testim also refers to Testim as Testosterone gel 1% CIII, but it obviously different since it received its own patent. It think that SWALE said that Testim has something else added to it, although I can't remember the word he used to describe what was added.

    It'll be interesting to see if pharmacies start filling prescriptions for 'Testim' with this new generic product. Technically, I believe that they shouldn't. But hey, pharmacies have filled prescriptions from Androgel with Testim, much to the dismay of Solvay which I assumed worked to stop that practice.
    Last edited: Feb 12, 2006
  2. #2

    SWALE Doctor of Osteopathic Medicine

    Nice find, mranak.

    Testim has an emollient added to it. Other than that, it is the same as androgel. Same dosing, same bioavailability.

    The emmollient smells good to some, like skunk cabbage to others.
  3. #3

    mranak Junior Member

    I just remembered the word 'emollient' when looking at the generic approvals list for last year (Tretinoin Cream Emollient: Renova) and I came here to update my post. But you beat me, so you get the points. :D
  4. #4

    Sunkist Junior Member

    General musing:

    It totally amazes me how one can refer to a generic of something where the active indredient is a natural substance found in the body. The only thing that is innate to androgel is I assume the vehicle and packaging. I used one package several years ago right after diagnosis. My compounded 10% creme is many times the product in all constructs that are applicable to the process. The only difference is it is far less expensive.
  5. #5

    mranak Junior Member

    Can you clarify that statement?

    Anyway, while I agree that androgel is overpriced, I am thankful it come onto the market for a variety of reasons:

    - The approval of the product meant that clinical studies were done.

    - FDA approval means that the FDA endorsed transdermal testosterone therapy. And that means that more physicians endorse it. This is very significant.

    - It gave us a consistent product that is available in any standard pharmacy.

    - More physicians became aware of TRT because of Androgel

    - The package insert for Androgel is actually correct, whereas the package insert for testosterone cypionate (dosing q 2-4w) is inappropraite. Thus, perhaps physicians that aren't good with TRT tend to do a better job with Androgel

    - More men receive the TRT they need because of Androgel

    - Androgel is a good product. It isn't for me, but I'm happy that it is available to the men that want it ... provided they never take away my testosterone cypionate!

    - Right now, Solvay is funding a clinical trial of TRT for diabetic men. This will hopefully bring more attention to the fact that many diabetic men can be helped with TRT.

    The existing compounded testosterone transdermals are still available to those that want them, so no problem there.
  6. #6

    marianco Doctor of Medicine

    Actually, I think the bioavailability of Androgel is much better than Testim.

    Looking at the prescribing information: the average ( SD) daily testosterone concentration produced by AndroGel 10 g on Day 30 was 792 ( 294) ng/dL. In contrast, the average daily testosterone concentration produced by Testim 100 mg at Day 30 was 612 ( 286) ng/dL.

    Inactive ingredients in AndroGel are ethanol 67.0%, purified water, sodium hydroxide, carbomer 980 and isopropyl myristate

    Inactive ingredients in Testim are purified water, pentadecalactone, carbopol, acrylates, propylene glycol, glycerin, polyethylene glycol, ethanol (74%), and tromethamine.

    Androgel is a much more effective formulation. If anything, the emollient in Testim impairs the absorption of testosterone. Isopropyl myristate in Androgel, I believe, accelerates the absoroption of testosterone, better than what is in Testim, despite the higher alcohol content of Testim.

    If an alcohol-based testosterone gel is preferred, I would prefer using a higher potency compounded testosterone gel - which would be less expensive if bought out-of-pocket compared to the commercial gels.
  7. #7

    pmgamer18 Junior Member

    Every thing I was told before going from Androgel to Testim was the Testim's absorption was better then Androgel. So when my Dr. put me on Testim he cut the dose back to 5 grams from 10. In two weeks I was crashing levels dropping big time. So my Dr. upped it back to 10 grams. Now on Androgel my levels were around 550 for Total T and on Testim I stayed at 650 so for me it has a higher absorption then Androgel. Then later I came across a study saying this. But I will be dammed I can't find the study.
  8. #8

    marianco Doctor of Medicine

    It thus looks like "Your mileage may vary".
  9. #9

    pmgamer18 Junior Member

  10. #10

    doughbooy Junior Member

    Has anyone been able to get the generic gel yet?

    I am switching from shot to gel and androgel is $50 - ouch. Just curious if this is indeed out yet, when I went to Watson's website I could not find any info on the gel, when it came to testosterone all I could find was the cyp and androderm.

  11. #11

    jimdmcd Junior Member

    Solvay has patient help programs for people on perscriptions to help defray the cost of androgel.
    I believe most doctors can get a Solvay "debit card" from their samples salesmen. This will pay a $15 copay.
    There are also programs for more help at the website .

    1-800-981-9816 is the customer service phone number listed on the "debit card"
  12. #12

    doughbooy Junior Member

    Thank you but I do not think I will qualify. The local pharmicist said there was no generic. Im going to call Watson tomorrow to see what is up. Hopefully others can chime in.


  13. #13

    pmgamer18 Junior Member

    Look if money is a problem go to Collage Pharmacy send them an Email saying you want a compounded T gel that is = to androgel and get a price. I feel this is even better the using Androgel because if your levels are not up high enough they just make it stronger.
  14. #14

    doughbooy Junior Member

    Im working with Dr Crisler so for now Ill stick to what he wants. Ill have to do mail order which brings the price down to $33 per month.

    Spoke with Watson, yes they have been approved, no it hasnt been made yet and the woman I spoke with was unable to provide a launch date.

  15. #15

    masterpp Junior Member

    random question. how much broadly does it cost to do testosterone shots (either encanthanate or cynthinate = sorry bout spelling). testogel costs about 40 pounds a month if one doesnt have health care

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