Last updated: February 27, 2026
What is the drug associated with NDC 17139-0562?
NDC 17139-0562 corresponds to Xyosted (Testosterone Enanthate) Injectable, indicated for testosterone replacement therapy (TRT) in adult males with confirmed hypogonadism.
Current Market Position
Xyosted is marketed by Antares Pharma, approved by the FDA in August 2018. It provides a weekly subcutaneous injection, positioning itself as an alternative to intramuscular testosterone therapies.
The drug targets a niche for patients preferring subcutaneous injections, which are associated with fewer injection site reactions and easier administration.
Market Size and Trends
Market Demand
- Hypogonadism prevalence: Approximately 2.4 million men in the U.S. diagnosed with hypogonadism, with a growing diagnosis rate due to increased awareness and testing.
- Market penetration: Testosterone replacement therapies (TRTs) in 2021 had an estimated U.S. market size of $2.4 billion, with injectable formulations accounting for roughly 30%—around $720 million.
- Growth prospects: The compounded annual growth rate (CAGR) for TRT was projected at 4% over the next five years, driven by aging population and increased diagnosis.
Competitive Landscape
- Major competitors: Depo-Testosterone (intramuscular, Pfizer), AndroGel (topical, AbbVie), Axiron (topical, eli Lilly), and generic testosterone enanthate injectables.
- Differentiators: Xyosted's subcutaneous administration provides convenience and potentially improved compliance, appealing to a subset of patients.
Pricing Analysis
Current Pricing
- Recommended Wholesale Price (RWP): Approximately $98 per 1 mL prefilled syringe (per unit). Actual pharmacy acquisition costs tend to be lower.
- Per Dose Cost: Around $18-$25 per weekly injection, depending on pharmacy discounts and insurance coverage.
Comparison with Competitors
| Drug |
Formulation |
Approximate Cost per Dose |
Market Segment |
| Xyosted |
Subcutaneous injection |
$20 |
Alternative to intramuscular |
| Depo-Testosterone |
Intramuscular injection |
$10-$15 |
Traditional TRT |
| AndroGel |
Topical gel |
$30-$50 (monthly) |
Non-invasive TRT |
| Axiron |
Transdermal solution |
$40-$60 (monthly) |
Non-invasive TRT |
Price Trends
- The price of injectable testosterone has decreased over past five years owing to increased generic competition.
- Xyosted's premium positioning persists due to subcutaneous delivery's convenience, which justifies a higher price point compared to traditional intramuscular products.
Regulatory and Policy Factors
- FDA approval ensures patent and exclusivity periods, typically 5 years, impacting pricing strategies.
- Insurance coverage favors branded drugs like Xyosted, with reimbursement rates comparable to traditional formulations.
- Price transparency initiatives and pharmacy benefit managers' (PBMs) negotiations influence out-of-pocket costs for patients.
Revenue Projections
- 2023: Approximately $25 million in U.S. sales, based on current market penetration.
- 2026: Expected to reach $45-$55 million if market share grows from 4% to 8%, driven by increasing diagnoses and favorable physician adoption.
- Key growth drivers: Patient preference for subcutaneous injections, aging population, expanded insurance coverage.
Market Expansion Opportunities
- International markets: Limited penetration outside the U.S., with potential in Europe and Asia where TRT is gaining recognition.
- Line extensions: Longer-acting formulations or combination products could expand usage.
- Physician education: Increasing awareness of subcutaneous delivery benefits may attract new patients.
Risks and Barriers
- Entry of biosimilars or generics could pressure prices.
- Strictly regulated pricing environments and reimbursement policies can limit profit margins.
- Competition from emerging non-injectable options may erode market share.
Key Takeaways
- NDC 17139-0562 (Xyosted) occupies a niche within the TRT market with moderate current value but high growth potential.
- Price per dose remains competitive with intramuscular formulations, with slight premiums justified by delivery advantages.
- Market growth relies on expanding diagnosis rates, physician acceptance, and patient preference shifts toward subcutaneous injections.
- International expansion and line extension development are critical for long-term revenue growth.
- Price pressures from biosimilars and regulatory policies may influence profit margins.
FAQs
Q1: What is the main differentiator for Xyosted in the TRT market?
The convenience of weekly subcutaneous injection compared to intramuscular options.
Q2: How does the pricing of Xyosted compare to intramuscular testosterone injections?
It costs approximately $20 per weekly dose, marginally higher than intramuscular options at $10-$15, reflecting delivery method advantages.
Q3: What are the growth drivers for Xyosted's market?
Increasing hypogonadism diagnoses, patient preference for subcutaneous delivery, and expanded insurance reimbursement.
Q4: What risks could impact Xyosted's market share?
Introduction of biosimilars, decreasing pricing power, and competition from topical or long-acting formulations.
Q5: Are there opportunities for price increases?
Limited, due to competitive pressures and regulatory constraints, but premiums can persist if delivery benefits are emphasized.
References
[1] IQVIA. (2022). Pharmaceutical Market Overview.
[2] FDA. (2018). Xyosted (Testosterone Enanthate) Prescribing Information.
[3] EvaluatePharma. (2021). Global Testosterone Market Analysis.
[4] Centers for Disease Control and Prevention. (2022). Hypogonadism Statistics.
