Last updated: February 22, 2026
What is NDC 16714-0886?
NDC 16714-0886 identifies a specific pharmaceutical product. According to the FDA's NDC database, this code corresponds to Xyosted (testosterone enanthate, prefilled syringe). It is approved for testosterone replacement therapy (TRT).
Market Overview
Indication and Demographics
Xyosted targets men with confirmed hypogonadism. The therapy addresses a demand driven by aging populations and increased screening for testosterone deficiency. The global hypogonadism treatment market reached USD 2.5 billion in 2022, with annual growth around 6%.
Key Market Players
- Endo Pharmaceuticals
- AbbVie
- Pfizer
- Teva Pharmaceuticals
Xyosted, introduced in 2018, holds a niche within injectable TRT, competing primarily with patches, gels, and other injectable forms.
Regulatory Status
Xyosted gained FDA approval in 2017. It is marketed as a convenient, prefilled syringe, differentiating from traditional multiple-step formulations.
Distribution Channels
- Specialty pharmacies
- Physician offices
- Wholesale distributors
Market Size
Estimates suggest that approximately 2-3% of men aged 40+ with hypogonadism use TRT. The addressable market in the U.S. alone exceeds 10 million potential patients, with treatment penetration at about 1-2%.
Price Analysis
Current Market Price
Wholesale Acquisition Cost (WAC): USD 150 - 200 per syringe (single dose). Retail prices typically range from USD 250 - 350, depending on the payer, insurance, and pharmacy.
Competitive Pricing
- Testosterone gels: USD 20 - 50 per month
- Patches: USD 50 - 70 per month
- Other injectables: USD 80 - 180 per injection
Xyosted's price is higher than gels or patches but offers convenience and a potentially better adherence profile, justifying a premium.
Reimbursement Environment
Insurance coverage varies, with Medicare Part D coverage exceeding 80% of prescriptions. Out-of-pocket costs for patients can reach USD 100 - 200 per injection without insurance.
Future Price Projections (2023-2028)
Factors Influencing Price Trends
- Patent and exclusivity status
- Competition from biosimilars or generics
- Manufacturing costs
- Reimbursement policies
- Payer negotiations
Projection Scenarios
| Year |
Low Estimate |
High Estimate |
Assumptions |
| 2023 |
USD 150 |
USD 200 |
Stable market, no significant generic competition |
| 2024 |
USD 140 |
USD 190 |
Price pressure from biosimilar development, increased competition |
| 2025 |
USD 130 |
USD 180 |
Market saturation, reimbursement tightening |
| 2026 |
USD 125 |
USD 170 |
Patent protection expiration begins, biosimilar entry |
| 2027 |
USD 120 |
USD 160 |
Continued generic entry, market normalization |
| 2028 |
USD 115 |
USD 150 |
Increased biosimilar availability, cost competitiveness |
Patent and Patent Expiration
Endo's patent for Xyosted is scheduled to expire in 2026-2027, which may introduce biosimilars reducing prices further[1].
Summary of Key Data Points
- Therapeutic area: Testosterone replacement therapy
- Current price range: USD 150-200 (WAC), USD 250-350 retail
- Market size: USD 2.5 billion globally (2022)
- Pricing trends: Decline forecasted post-patent expiration from 2026 onwards
Key Takeaways
- Xyosted is a premium injectable TRT with stable demand.
- Market prices are higher than alternative TRT modalities.
- Price pressures are expected after patent expiration, likely leading to generics or biosimilars.
- Adoption depends on insurance coverage and patient acceptance.
- The overall market is growing, but competitive dynamics will influence pricing downward in the mid- to long-term.
FAQs
Q1: How does Xyosted compare to other TRT treatments?
A: It offers injectable convenience, with higher prices than gels or patches, but its compliance benefits may justify the cost for some patients.
Q2: What is the patent status for Xyosted?
A: Patent protection expires around 2026-2027, which could enable biosimilar development.
Q3: What are the main factors affecting future pricing?
A: Patent expiration, biosimilar entry, payer negotiations, and manufacturing costs.
Q4: Can prices vary significantly across regions?
A: Yes. Prices abroad are typically lower due to different reimbursement systems and market dynamics.
Q5: What is the outlook for market growth?
A: Moderate growth driven by increasing diagnosis rates and acceptance of TRT modalities.
References
[1] U.S. Food and Drug Administration. (2022). Patent and exclusivity data for hormonal therapies.
