Last updated: February 15, 2026
What is the current market landscape for NDC 16714-0140?
NDC 16714-0140 is the product code for Xyosted, a long-acting testosterone enanthate injection used for testosterone replacement therapy. Market entry occurred upon FDA approval. Its primary competitors include other testosterone formulations such as gels, patches, and competing injectables.
Market size trends indicate increasing demand driven by aging male populations and indications of hypogonadism. The global testosterone replacement therapy (TRT) market was valued at approximately $2.75 billion in 2022, with a compound annual growth rate (CAGR) of 4-6%, expected to reach $4 billion by 2027 [1].
From a pricing perspective, Xyosted launched at a list price around $1,060 per 10 mL vial, equating to roughly $106 per mL. This price aligns with other injectable testosterone formulations but remains higher than gels or patches, which typically cost between $30-$60 monthly.
How does price competitiveness compare with similar products?
| Product |
Formulation |
Typical Monthly Cost |
Estimated Dose (per month) |
Price per mL |
| Xyosted (NDC 16714-0140) |
Long-acting injection |
$106 (per vial) |
10 mL vial, enough for ~40 days |
$106 |
| AndroGel 1.62% |
Gel |
$50-$60 |
Approx. 60-80 g/month |
N/A (pricing varies) |
| Androderm patch |
Patch |
$60-$80 |
30 patches/month |
N/A (roughly $2.67 per patch) |
| Testim |
Gel |
$60-$70 |
50g/month |
N/A |
Injectable formulations typically justify higher prices through longer dosing intervals and perceived efficacy. Xyosted’s once-weekly or bi-weekly administration offers convenience versus daily gels or patches.
What are the key factors influencing future price projections?
Market Dynamics: Increasing prescribing trends coupled with patent protections keep prices stable or trending upward. However, potential generic entry post-patent expiry (expected around 2030) could pressure prices downward.
Regulatory and Reimbursement Environment: Insurance coverage, Medicare, and Medicaid policies significantly affect patient access and pricing. Reimbursement rates influence provider willingness to prescribe at certain price points.
Competitive Innovation: New delivery systems, biosimilar developments, or alternative therapies could alter market share and pricing. The absence of biosimilars for testosterone injections prolongs current pricing structures.
Manufacturer Strategies: Pricing strategies prioritize market share growth, profit margins, and patient affordability. Data suggest Pfizer's focus on maintaining premium pricing for branded formulations like Xyosted.
What are the future price projections for NDC 16714-0140?
Analysts forecast that Xyosted's price per mL will remain stable over the next 2–3 years, with minimal decline unless patent expiration or biosimilar competition emerges. Predictions suggest maintaining current list prices for at least 12-24 months, with slight reductions in reimbursement rates possibly pushing net prices down.
Long-term, the entry of biosimilars or alternative delivery systems could lead to a decrease of 15-25% in average injectable testosterone prices over 5–7 years.
Summary of projections:
- 2023–2024: Stable list price at approximately $106 per mL.
- 2025–2027: Possible slight decline of 5–10% in net prices due to market pressures and reimbursement adjustments.
- Post-2030: Potential price reductions of 20–25% coinciding with patent expiry and biosimilar entry.
Key considerations for stakeholders:
- Patents on Xyosted expire in 2030, opening opportunities for biosimilar entry.
- Reimbursement policies are evolving, potentially impacting retail pricing and access.
- Competitive injection therapies and patient preferences for less invasive options will influence market share and pricing pressure.
Key Takeaways
- The current price for NDC 16714-0140 (Xyosted) is about $106 per mL, positioning it as a premium injectable testosterone therapy.
- Market growth driven by demographic trends and clinical preferences supports stable pricing in the near term.
- The lack of biosimilar competition maintains pricing power, but patent expiration around 2030 could alter dynamics.
- Future price declines are projected to be modest initially but could accelerate with biosimilar or alternative therapy approvals.
- Reimbursement policies and market acceptance will significantly impact net prices and patient access over the next several years.
FAQs
1. When are biosimilars expected for testosterone injections like Xyosted?
Biosimilars typically enter the market 10-12 years after initial patent filings. Given patent expiry around 2030, biosimilar options could debut circa 2030-2032.
2. How does the price of Xyosted compare to other testosterone injection therapies?
Xyosted’s price per mL is comparable to other long-acting injectables. It consistently exceeds gel or patch costs but offers less frequent administration.
3. What factors could cause price fluctuations for NDC 16714-0140?
Patent expiration, market entry of biosimilars, reimbursement policy changes, and competitive product launches.
4. How does insurance coverage impact the retail price of Xyosted?
Reimbursement agreements and formulary placement influence out-of-pocket costs. High coverage levels can stabilize net prices for providers and reduce patient costs.
5. What is the global market outlook for testosterone replacement therapies?
Market size is expected to grow steadily at 4-6% CAGR through 2027, driven by demographic shifts and increasing acceptance of hormone therapy.
References
[1] Transparency Market Research. "Testosterone Replacement Therapy Market," 2022.
