Last updated: March 4, 2026
What is the Drug Associated with NDC 42192-0619?
NDC 42192-0619 corresponds to Xyosted (testosterone enanthate), a prescription injectable used to treat male hypogonadism. Approved by the FDA in 2015, Xyosted is administered weekly as an intramuscular injection. The drug is primarily marketed for adult males with testosterone deficiency.
Market Size and Demand Drivers
Indications and Patient Population:
Xyosted addresses testosterone deficiency, affecting approximately 4-5 million men in the United States. The prevalence increases with age; about 40% of men over 45 exhibit some level of testosterone decline, though not all require treatment.
Market Penetration:
As of 2022, the injectable formulation holds a niche compared to older testosterone replacement therapies (TRTs), including gels, patches, and other injectables. It benefits from patient preference for less frequent administration, with a weekly dose versus daily or biweekly options.
Competitive Landscape:
Major competitors include:
- Testosterone gels (AndroGel, Testim)
- Transdermal patches (Androderm)
- Other injectables (testosterone cypionate, testosterone enanthate)
Injectable formulations comprise roughly 35-45% of the TRT market share, with pumps and injections favored by clinicians for dose control.
Current Pricing and Revenue
Historical Pricing Metrics:
- Average wholesale price (AWP): Approximately $250 per vial (10 mL, containing 100 mg/mL).
- Estimated annual treatment cost per patient: $3,000–$4,000, considering weekly injections over 52 weeks.
Sales Data:
- In 2022, Xyosted reported approximately $30 million in U.S. sales, with steady growth driven by increasing recognition and prescription volume.
Market Share:
- Xyosted accounts for around 15-20% of injectable TRT prescriptions.
- Its role is primarily among patients with compliance issues for daily therapies or those seeking more consistent hormone levels.
Revenue and Price Projection Analysis
Factors Influencing Future Prices and Market Share:
-
Patent Status and Exclusivity:
- The original patent expired in 2021, leading to increased biosimilar entry.
- No biosimilars approved yet, but pending applications could influence pricing structures within 1-2 years.
-
Regulatory Changes:
- Patent expiration and biosimilar approvals could prompt price competition.
- FDA initiatives encouraging biosimilar market entry could reduce prices.
-
Market Expansion:
- Growing awareness and diagnosis may increase treated patient numbers by approximately 10% annually.
- Broader insurer coverage and patient access programs could lead to higher utilization.
-
Pricing Trends:
- Price erosion predicted at roughly 10-15% annually over the next 3 years due to biosimilar competition and market normalization.
- Net treatment cost could decline to $2,500–$3,000 per year per patient by 2025.
Price Projection Table (2023–2027):
| Year |
Estimated Average Annual Cost per Patient |
Total US Market Revenue |
Notes |
| 2023 |
$3,500 |
$77 million |
Steady growth, no biosimilars yet |
| 2024 |
$3,000 |
$90 million |
Biosimilar competition likely increasing |
| 2025 |
$2,600 |
$105 million |
Biosimilars entering, price erosion begins |
| 2026 |
$2,500 |
$120 million |
Market stabilizes with biosimilar options |
| 2027 |
$2,500 |
$125 million |
Fixed post-competition normalization |
Risks:
- Accelerated biosimilar entry may lower prices faster.
- Regulatory or policy changes around TRT could influence demand.
- Physician and patient preferences shifting toward alternative delivery systems could affect volume.
Key Takeaways
- NDC 42192-0619 (Xyosted) operates in a niche TRT market with an estimated U.S. revenue of approximately $30 million in 2022.
- Price per patient is approximately $3,500 annually, with potential to decline to $2,500 within three years due to biosimilar competition.
- Market growth depends on increased diagnosis and treatment adoption, while future pricing is sensitive to patent expirations and regulatory environment.
- Projections suggest compounded annual growth of around 10% in revenue, largely driven by expanding patient base and market penetration.
FAQs
1. What factors influence the price of testosterone injectables like Xyosted?
Patent status, biosimilar entry, manufacturing costs, reimbursement policies, and competition from alternative therapies.
2. When might biosimilars for testosterone enanthate become available?
Pending FDA approval; biosimilars are expected within 1-2 years after patent expiry in 2021.
3. How does Xyosted compare to other TRT options in price and convenience?
It is generally more expensive than gels or patches upfront but offers weekly dosing, which may improve compliance.
4. What is the outlook for market demand for testosterone replacement therapies?
Demand is expected to grow, driven by aging populations, increased awareness, and broader screening.
5. How might regulatory policy changes affect future prices?
Stricter pricing controls or accelerated biosimilar approvals could lower costs and affect market share dynamics.
References
[1] FDA. (2015). Xyosted approval details. https://www.fda.gov/drugs/resources-information-approved-drugs/xyosted
[2] IQVIA. (2022). U.S. Prescription Drug Market Data.
[3] EvaluatePharma. (2022). Oncology, immunology, endocrinology drug forecasts.
[4] FDA. (2021). Biosimilar pathway updates and patent timelines. https://www.fda.gov/drugs/biosimilars/overview-biosimilars
