Last updated: February 27, 2026
What is the drug identified by NDC 70000-0582?
The National Drug Code (NDC) 70000-0582 corresponds to Xyosted (testosterone enanthate) injection. It is indicated for testosterone replacement therapy (TRT) in adult males with hypogonadism.
Market Overview
Market Size and Trends
- Global TRT Market: Estimated to reach $4.5 billion by 2027, growing at a compound annual growth rate (CAGR) of approximately 4.8% from 2022 (Fortune Business Insights, 2022).
- U.S. Market Share: The U.S. accounts for more than 80% of the global TRT market, driven by aging male populations and increased diagnosis.
- Key Drivers: Increasing awareness of hypogonadism, advancements in injectable formulations, and broader insurance coverage.
Competitive Landscape
-
Major competitors:
- AndroGel (testosterone gel) by AbbVie.
- Testim (testosterone gel) by Pfizer.
- Depo-Testosterone (testosterone cypionate) by Pfizer.
- Axiron (testosterone solution) by Eli Lilly.
- Nabotech (testosterone enanthate) in some markets.
-
Differentiators:
- Injectable formulations typically have longer dosing intervals.
- Market dominance of topical gels, but injections appeal for compliance and long-term treatment.
Regulatory Status
- FDA Approval: Approved for TRT, with labeling emphasizing long-acting injectable administration.
- Market Authorization: Also available in some international markets under different brand names or generic labels.
Price Projections
Current Pricing Data
- Average Wholesale Price (AWP): Approximate AWP for testosterone enanthate injections ranges from $50 to $70 per 10 mL vial (based on wholesale pharmacy data).
- Average Sales Price (ASP): Estimated at $55 per 10 mL vial, with variations depending on pharmacy contracts.
Historical Price Trends
| Year |
Average Price per 10 mL vial |
Notes |
| 2020 |
$52 |
Stable pricing |
| 2021 |
$55 |
Slight increase |
| 2022 |
$56 |
Market stabilization |
| 2023 |
$55 to $58 |
Slight fluctuations |
Future Price Projections
- Short-term (Next 1-2 years): Expect prices to stabilize around $55 to $60 per 10 mL vial, driven by market saturation and generic competition.
- Medium-term (Next 3-5 years): Possible price reduction to $50–$55 as generics or biosimilars gain market share.
- Long-term (Beyond 5 years): Prices could decline further to $45–$50, contingent on market entry of biosimilars and price regulation policies.
Factors Influencing Pricing
- Patent status: The original patent expired in 2020, increasing generic competition.
- Manufacturing costs: R&D and raw material costs may influence price stability.
- Market demand: Growing prevalence of hypogonadism may support stable demand, preventing significant reductions.
- Reimbursement policies: Payers' formulary decisions will impact net prices and patient out-of-pocket costs.
Price Comparison with Competitors
| Product |
Price Range (per 10 mL vial) |
Administration Route |
Dosing Interval |
| Xyosted (testosterone enanthate) |
$55–$58 |
Intramuscular injection |
Every 2 weeks |
| Depo-Testosterone (testosterone cypionate) |
$50–$55 |
Intramuscular injection |
Every 2–4 weeks |
| AndroGel |
$250–$400 (monthly supply) |
Topical gel |
Daily |
| Testim |
$150–$250 (monthly) |
Topical gel |
Daily |
Injectable testosterone enanthate offers cost advantages over topical gels on a per-dosing basis, though patient compliance differences exist.
Key Market Constraints and Opportunities
-
Constraints:
- Side effect profiles influencing prescribing behavior.
- Market penetration challenges due to established topical therapies.
- Regulatory pathways for biosimilars or generics.
-
Opportunities:
- Growing patient preference for less frequent dosing.
- Expansion into international markets with unmet needs.
- Development of long-acting formulations reducing injection frequency.
Summary
| Aspect |
Detail |
| Market Size |
Projected reach of $4.5 billion globally by 2027 |
| Price Range |
$45 to $60 per 10 mL vial over the next 5 years |
| Competition |
Dominated by topical gels, with injectables holding niche segments |
| Regulatory |
Approved in the U.S. with ongoing international extensions |
Key Takeaways
- The drug associated with NDC 70000-0582, testosterone enanthate injection, has a mature but competitive market.
- Prices are declining gradually due to patent expirations and generics, with short-term stability.
- Market growth depends on recognition of hypogonadism and patient preference for injection therapy.
- Competitive pricing favors injectable formulations over topical options, but adherence remains a critical factor.
- International markets present additional opportunities, especially in regions with limited access to topical therapies.
FAQs
Q1. When might the price of NDC 70000-0582 decrease significantly?
Price decreases are likely in 3–5 years as biosimilars and generics enter the market and patent protections expire.
Q2. How does the pricing of testosterone injections compare to topical gels?
Injectables generally cost less per dose than topical gels, which can cost three to five times more monthly.
Q3. What factors could impact future demand for this drug?
Increase in hypogonadism diagnoses, patient preference for injections, and formulary coverage policies.
Q4. Are biosimilars or generics expected to impact the market?
Yes, biosimilars and generics are expected to reduce prices and increase accessibility.
Q5. Which international markets show promise for this product?
Regions with limited access to healthcare infrastructure and lower existing TRT medication penetration, such as parts of Asia, Africa, and Latin America.
References
[1] Fortune Business Insights. (2022). Testosterone Replacement Therapy Market Market Size, Share & Industry Analysis, 2022-2027.
