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Yes, There Is a Generic for Testosterone Enanthate Injection: What to Know About Availability and Formulations

4 min read

In recent years, injectable testosterone products have been a prominent choice for patients, accounting for a significant majority of all testosterone prescriptions filled. For those considering this option, a common question is, is there a generic for testosterone enanthate injection? The answer is yes, though it depends on the specific formulation you are prescribed.

Quick Summary

Yes, generic intramuscular testosterone enanthate is widely available, with FDA-approved equivalents replacing the discontinued Delatestryl brand. However, the newer subcutaneous autoinjector version, Xyosted, remains available only as a brand-name medication.

Key Points

  • Generic availability: Yes, there is a generic for the traditional intramuscular (IM) testosterone enanthate injection, which is typically supplied in multi-dose vials.

  • Brand-name autoinjector: The subcutaneous autoinjector form, Xyosted, is only available as a brand-name product and does not have a generic version.

  • Affordability: Generic intramuscular injections are typically a more cost-effective option compared to the brand-name subcutaneous autoinjector.

  • Discontinued brand: The former brand-name IM product, Delatestryl, is no longer marketed in the U.S., but generic equivalents are widely used.

  • Enanthate vs. Cypionate: Testosterone enanthate is pharmacologically very similar to testosterone cypionate, another common injectable ester, though they differ in their carrier oil and potential injection frequency.

  • Informed decision: Choosing between generic enanthate, brand-name Xyosted, or other testosterone formulations should be based on a discussion with a healthcare provider about cost, convenience, and treatment goals.

In This Article

The Different Forms of Testosterone Enanthate

Testosterone enanthate is a long-acting esterified variant of the hormone testosterone, designed for injection to provide a sustained release of the hormone into the body. This extended-release profile helps to maintain more stable hormone levels compared to faster-acting preparations. However, the availability of a generic version hinges on whether the formulation is for intramuscular (IM) or subcutaneous (sub-Q) use.

For the traditional intramuscular injection, FDA-approved generic versions are readily available. These are typically supplied in multi-dose vials at a concentration of 200 mg/mL and are a cost-effective option for many patients. The original brand-name version for the IM injection, Delatestryl, has been discontinued in the United States, leaving the generic formulation as the standard treatment.

In contrast, the subcutaneous (under-the-skin) autoinjector product, Xyosted, is available only as a brand-name medication and does not have a generic version. Xyosted offers the convenience of at-home self-administration, eliminating the need for clinic visits for injections. This convenience, however, comes at a higher cost compared to the generic intramuscular vials.

Comparing Testosterone Enanthate with Other Injectables

When discussing injectable testosterone, the most common comparison is with testosterone cypionate. While often considered interchangeable for treating male hypogonadism, they have minor differences in their chemical structure, carrier oil, and half-life, which can influence injection frequency and patient experience. Both are Schedule III controlled substances due to their potential for misuse and dependence.

Testosterone Enanthate vs. Testosterone Cypionate

Feature Testosterone Enanthate Testosterone Cypionate
Generic Availability Yes, for intramuscular vials Yes, for intramuscular vials
Brand Name Options Xyosted (sub-Q autoinjector, no generic); Delatestryl (discontinued IM) Depo-Testosterone (IM)
Typical Carrier Oil Sesame oil Cottonseed oil
Oil Consistency Thicker, can be more difficult to draw and inject Thinner, generally easier to draw and inject
Release Half-Life Approximately 7-9 days Approximately 8 days
Injection Frequency Typically every 7 to 10 days for stable levels Typically every 7 to 10 days, or sometimes every 2 weeks

The Pharmacology Behind the Ester

The enanthate ester is a fatty acid chain attached to the testosterone molecule. This esterification makes the testosterone molecule more lipophilic (fat-soluble). When injected into the muscle, the oil solution containing the ester forms a depot, or reservoir. Esterase enzymes in the body then slowly break down the ester bond, gradually releasing free, active testosterone into the bloodstream. The length of the ester chain determines the rate of release, with longer esters resulting in a slower, more prolonged release. Testosterone enanthate and cypionate have similar ester lengths, which is why their pharmacokinetic profiles are so comparable in practice.

Why Generic Availability Matters

The availability of a generic version can significantly impact the affordability and accessibility of medication. Generic drugs contain the same active ingredients as their brand-name counterparts and are required to meet the same strict quality and effectiveness standards set by the FDA. With the price of brand-name medications often being considerably higher, generic alternatives provide a critical pathway to affordable treatment for conditions like hypogonadism. For patients with insurance plans that do not cover brand-name products or who pay out-of-pocket, the availability of generic intramuscular testosterone enanthate can make the difference in their ability to continue therapy consistently.

Factors Influencing Your Choice

The decision between a generic and a brand-name medication, or even between different testosterone esters, should be made in consultation with a healthcare provider. Factors to consider include:

  • Cost: Generic options are almost always more affordable, especially for the multi-dose vials used for IM injection.
  • Convenience: The brand-name autoinjector Xyosted offers a more convenient self-injection method for those who prefer it.
  • Injection Experience: The carrier oil can affect the injection experience. Some patients may have a preference or a sensitivity to either sesame oil (enanthate) or cottonseed oil (cypionate).
  • Insurance Coverage: Different insurance plans have varying levels of coverage for brand versus generic drugs. Some may require a prior authorization for the brand-name product.
  • Response to Treatment: While the therapeutic effect is similar for both enanthate and cypionate, some individuals may find they tolerate one formulation better than another.

Conclusion

For patients seeking a generic for testosterone enanthate injection, the traditional intramuscular formulation is a readily available and cost-effective option. The once-brand-name Delatestryl has been replaced by multiple FDA-approved generic equivalents. However, the newer subcutaneous autoinjector, Xyosted, is only available as a brand-name product. Patients should discuss their treatment goals, budget, and lifestyle with their healthcare provider to determine the most appropriate testosterone formulation, weighing factors like cost, convenience, and individual tolerance to make an informed decision.

Visit the FDA's Drugs@FDA database to search for specific drug approvals and generic equivalents.

Frequently Asked Questions

Yes, there is a generic version of the traditional intramuscular testosterone enanthate injection. The once-available brand-name version, Delatestryl, has been discontinued in the U.S., and generic equivalents are now standard.

Generic testosterone enanthate is for intramuscular injection from a multi-dose vial, whereas Xyosted is a brand-name subcutaneous autoinjector. Xyosted does not have a generic equivalent, making the generic intramuscular version a more budget-friendly option.

Yes. The FDA requires that all generic medications, including injectable testosterone enanthate, have the same active ingredient, strength, safety, and quality as their brand-name counterparts. The therapeutic effect should be identical.

Generic testosterone enanthate is typically administered via deep intramuscular injection. The brand-name autoinjector, Xyosted, is for subcutaneous (under-the-skin) injection.

Generic intramuscular testosterone enanthate injections are significantly less expensive than brand-name alternatives like the Xyosted autoinjector, making them a more accessible and affordable treatment option.

For most patients, testosterone enanthate and cypionate are therapeutically equivalent. The main differences are the carrier oil used and minor variations in their pharmacokinetic profiles. Your doctor will help determine the best option based on your needs and how your body responds.

Some patients prefer Xyosted for its convenience, as it is a single-dose, prefilled autoinjector for at-home use. It eliminates the need for vials, needles, and drawing the medication, though this convenience comes at a higher price.

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.