Compounded injectable testosterone medications like cypionate are presently being pushed out of the market.
Compounding pharmacies provide a low cost alternative to standard and more expensive manufactured brand name medications. In the case of testosterone, compounding pharmacies are able to obtain the FDA approved raw material to compound testosterone into strengths, solutions, forms, and combinations not available on the market. Testosterone Cypionate is not under a patent, and is available as a raw material to be compounded as a sterile injectable in various custom strengths.
Technically, a compounding pharmacy is not supposed to compound a drug in the same strength and form already available as a brand name.
Since Testosterone Cypionate is available as a brand name (Pfizer, Watson, etc) in 10ml 200mg/ml form, many compounders alter the finished product to justify compounding it. For example they may offer it in a different strength, volume, or as a combination drug.
Similar to the lack of enforcement regarding the compounding of Sildenafil (Viagra), the compounding of Testosterone Cypionate 200mg/ml at 10ml is not enforced due to the fact this particular medication has been around for a long time, is cheap to produce, and was not a potential profit generator for big pharmaceutical companies until the recent rise in TRT availability and marketing.
In addition, it is also difficult to enforce this rule when a drug is compounded in a sterile injectable due to the compounders ability to subtly change the finished product by using different oils (like grapeseed instead of more common cottonseed), altering the strength (250mg/ml instead of 200mg/ml), or even combining different esters not available on the market as a brand (ex. Cypionate 80%/Propionate 20%).
Instead of being able to enforce patent violations, another method is being used to stop the compounding of Testosterone Cypionate. Through the continued establishment of redundant regulatory obstacles a compounder must go through to produce a sterile injectable, it is becoming more expensive to make sterile compounds including injectable testosterones.
To seize on the fast growing market big pharmaceutical brands like Pfizer’s Depot Testosterone are reducing their prices to become more competitive in order to gain the very high volume of residual sales generated from the prescribing of long term TRT. In addition, more generics are becoming available at a low price.
To provide cost comparison, the AWP for Depot Testosterone is roughly $122. The AWP for Westward generic Test Cyp 200mg/ml 10ml is roughly $112 (as of March 2016).
Note that there is only a $10 difference between the brand and generic, when typically the gap is far greater. The retail price for compounded Testosterone Cypionate 200mg/ml 10ml is typically around $50, give or take depending on the particular compounders volume and overhead. The wholesale price (what Walgreens pays for it before selling to you) of Depot Testosterone 200mg/ml 10ml is $46 while wholesale for Westward is roughly $41.
You can see by this comparison that the gap in price between brand and generic is closing, while the cost to compound this same medication is increasing due to continued layers of regulation designed to limit the compounding industry.
In recent weeks, the FDA has been visiting sterile compounders to specifically request samples of their compounded testosterone cypionate to test using their own lab to confirm sterility, potency, and endotoxin content.
Remember, this is in addition to the already required FDA approved third party testing that a compounder must send each batch through before dispensing to a patient. So basically the FDA is re-testing a medication that has already passed approval from a FDA-approved third party lab.
They are hunting for anything to be used as ammunition against compounders at this point. The third party testing is required on top of the compounding pharmacies own in-house testing, which must also be completed and documented using FDA approved methods. The high cost for third party batch testing contributes to the increased cost to compound testosterone cypionate.
At this time I will not mention the additional layers of costs added to establish beyond use dating as now required for compounders. Also not to mention the scheduling of testosterone as a controlled substance which creates more costs for both pharmacists and doctors to prescribe and dispense it.
This stuff is important because what is occurring behind the scenes will possibly result in limiting availability of testosterone cypionate (and many other medications) on the market resulting in increased price and decreased access to these medications.