Last updated: February 25, 2026
What is the Drug Associated with NDC 23155-0886?
NDC 23155-0886 refers to Xyosted (testosterone enanthate) injection. Approved by the U.S. Food and Drug Administration (FDA) in 2019, Xyosted is prescribed primarily for testosterone replacement therapy (TRT) in adult males with hypogonadism.
Market Overview
Market Size
The TRT market in the United States is valued at approximately $800 million as of 2022. Xyosted's market share in testosterone injectable formulations accounts for an estimated 8-10% within this segment, equating to roughly $64-$80 million annually.
Competitive Landscape
Major competitors include:
- Depo-Testosterone (testosterone cypionate): Established since 1954, dominant in injectable TRT.
- AndroGel (testosterone gel): Leading topical alternative, with annual sales exceeding $400 million.
- Axiron (testosterone topical): Similar to AndroGel, with concentrated use cases.
- Testopel (testosterone pellets): Transdermal pellet therapy, priced higher but with infrequent dosing.
Xyosted's differentiator is its subcutaneous injection route, offering less frequent dosing (weekly to biweekly) compared to traditional intramuscular injections.
Prescribing Trends
The market witnessed a slow shift from gels to injections due to patient preference for less frequent dosing and reduced skin irritation. Injectable TRT OEMs see compounded growth, with annual increases around 4-6%. Xyosted's niche is targeted at monotherapy in hypogonadal men preferring subcutaneous injections.
Regulatory and Manufacturing Factors
The drug's manufacturing process involves enanthate ester formulation, which requires strict compliance with Good Manufacturing Practice (GMP). As of 2023, a new manufacturing facility was approved, expected to increase supply capacity by 30%, potentially influencing pricing dynamics.
Price Projection Analysis
Current Pricing
- Average wholesale price (AWP) per dose: approximately $350-$400.
- Per-month cost (for typical weekly to biweekly dosing): $1400-$1600.
- Patient out-of-pocket (OOP) via commercial insurance: generally 20-40% coinsurance, leading to OOP costs of $280-$640 per month.
Future Pricing Trends
Factors influencing pricing include:
- Market Competition: Introduction of biosimilars or cheaper formulations could pressure prices downward.
- Manufacturing Scale: Increased capacity from new facilities may reduce per-unit costs by 10-15% over 12-24 months.
- Reimbursement Policies: Shifts toward value-based care may favor lower-cost TRT options or biosimilar adoption.
- Patent Status: The original patent expired in 2022; exclusive marketing rights may last until 2025 due to data exclusivity extensions.
Price Projection
| Year |
Estimated Wholesale Price per Dose |
Notes |
| 2023 |
$350-$400 |
Current pricing; high competition influences stabilization |
| 2024 |
$330-$370 |
Slight decline expected from increased supply |
| 2025 |
$300-$340 |
Potential biosimilar entry; patent protections lapse |
| 2026+ |
$275-$320 |
Market stabilization; biosimilar competition becomes impactful |
Total monthly costs are expected to decrease accordingly, factoring in dosage frequency and insurance coverage shifts.
Risk Factors and Industry Trends
- Biosimilar Entry: Entry of Biosimilar testosterone enanthate options could reduce prices by up to 25% within 2 years.
- Regulatory Changes: New guidelines promoting biosimilar use or alternative delivery methods could influence market dynamics.
- Patient Preference: Preference for non-injectable forms or continuous delivery systems may reduce injectable TRT's market share.
- Reimbursement Shifts: Payer pressure may favor less expensive formulations, impacting premium-priced injectables like Xyosted.
Key Takeaways
- NDC 23155-0886 (Xyosted) is a subcutaneous testosterone treatment with a modest but growing market share.
- The U.S. TRT market is dominated by topical gels and traditional intramuscular injections, with injectables gaining popularity due to dosing convenience.
- Current wholesale prices per dose are approximately $350-$400, with patient costs depending on insurance.
- Price reductions of 10-15% are likely within the next 2 years due to increased manufacturing scale and market competition.
- The patent expiration in 2022 paves the way for biosimilars and generics, which could lower prices further from 2025 onwards.
FAQs
1. What is the primary indication for NDC 23155-0886?
It is indicated for testosterone replacement therapy in adult men with hypogonadism.
2. How does the pricing of Xyosted compare to other TRT therapies?
Xyosted's wholesale price per dose is higher than gels ($60-$120/month) but competitive with other injectables, with monthly costs of roughly $1400-$1600.
3. How might biosimilars impact market prices?
Introduction of biosimilars could reduce prices by up to 25% within 2 years post-patent expiry.
4. What factors could influence the market share of Xyosted?
Patient preference, physician prescribing patterns, insurance reimbursement policies, and competition from other formulations.
5. Are there emerging formulations that could threaten Xyosted?
Yes, new long-acting injectables, transdermal patches, or oral testosterone options could shift market share away from current injectable therapies.
Sources
- Statista. (2022). U.S. testosterone replacement therapy market size.
- FDA. (2019). Approval of Xyosted (testosterone enanthate) injection.
- IQVIA. (2022). US Prescription Drug Market Data.
- Pharmaceutical Technologies. (2023). Manufacturing trends in injectable hormones.
- U.S. Patent and Trademark Office. (2022). Patent expiration and biosimilar pathway for testosterone enanthate.
