Last updated: March 13, 2026
What is NDC 13668-0141?
NDC 13668-0141 corresponds to Xyosted (testosterone enanthate injection). It is indicated for testosterone replacement therapy in adult males with hypogonadism. The drug received FDA approval in 2014. It is supplied as a single-dose prefilled syringe (1 mL, 75 mg/mL).
Current Market Landscape
Market Size and Demand Drivers
- The global testosterone replacement therapy (TRT) market was valued at approximately USD 2.3 billion in 2021.
- It is projected to grow at a compound annual growth rate (CAGR) of 4.9% through 2030 (Grand View Research, 2022).
Key Market Segments
| Segment |
Details |
| Demographics |
Men aged 40 and above, hypogonadism prevalence is approximately 4-5% of this group. |
| Treatment Settings |
Urologists, endocrinologists, primary care physicians. |
| Delivery Formations |
Injections, gels, patches, pellets. |
Competitive Landscape
- Major competitors: Pfizer's AndroGel, Eli Lilly's Axiron, and Endo's Testim.
- Injectable testosterone, like Xyosted, faces less competition because of administration route and convenience.
- The injectable form accounts for about 20% of TRT prescriptions in the U.S. (IQVIA, 2022).
Regulatory and Reimbursement Dynamics
- Xyosted is FDA-approved, with a REMS program due to potential misuse.
- Reimbursement reimbursement rates vary; insurance coverage is generally favorable due to recognized clinical efficacy.
- The evolving guidelines for TRT influence prescribing patterns.
Price Trends and Projections
Current Pricing Overview
| Parameter |
Data |
| Average Wholesale Price (AWP) per syringe |
USD 300–350 (approximate, varies by distributor) |
| Prescription Prevalence |
Estimated 250,000 to 300,000 annually in the U.S. (IQVIA, 2022) |
| Cost to Patients |
Typically USD 350–400 per month, depending on coverage |
Factors Influencing Price Movements
- Manufacturing costs: Slight reduction expected with scale.
- Competitive pressures: Limited, given unique injection route.
- Reimbursement policies: Shifts toward value-based care may influence negotiated prices.
- Regulatory changes: Post-market surveillance controls can impact supply chain costs.
Projected Market Price Trends (Next 3–5 Years)
| Year |
Estimated Price Range per Syringe |
Notes |
| 2023 |
USD 290–340 |
Stable, with minor fluctuations within this band. |
| 2024 |
USD 280–330 |
Slight decrease expected due to increased competition in injectables. |
| 2025 |
USD 275–320 |
Continued price stabilization, potential downward pressure from emerging biosimilars or generics. |
Price Projection Summary
- Prices will largely stay within the USD 275–340 range through 2025.
- Price declines may accelerate if biosimilar injectables enter the market.
- Conversion rates for insurance reimbursements remain consistent, supporting stable cash flows.
Outlook and Strategic Implications
- Companies targeting this segment should monitor regulatory shifts and reimbursement policy changes.
- The injectable route's niche status offers pricing power but remains sensitive to manufacturing and raw material costs.
- Market growth driven by aging male population and increased TRT acceptance supports volume expansion more than price hikes.
Key Takeaways
- NDC 13668-0141, Xyosted, competes mainly in the injectable TRT segment.
- The market is valued at around USD 2.3 billion globally, with projected growth.
- Current wholesale prices hover around USD 300–350 per syringe.
- Future price declines are likely modest, constrained by limited competition.
- Reimbursement and regulatory factors will influence pricing dynamics as the market matures.
FAQs
1. How does the price of Xyosted compare internationally?
Prices vary significantly, with European and Asian markets typically offering injections at 20-40% lower due to different regulatory and reimbursement frameworks.
2. What is the impact of biosimilars on injections like Xyosted?
If biosimilars enter the market, prices could decline by 15-25%, driven by increased competition and lower manufacturing costs.
3. How recent regulatory changes could affect pricing?
Enhanced post-market surveillance and REMS requirements could increase compliance costs, potentially raising prices marginally.
4. Are there specific reimbursement challenges for Xyosted?
Insurance coverage favors TRT injections; however, shifts toward generic pricing and value-based care may pressure margins.
5. Which factors are most likely to influence price trends over the next five years?
Market competition, biosimilar entry, manufacturing costs, and reimbursement policies.
References
- Grand View Research. (2022). Testosterone Replacement Therapy Market Size, Share & Trends.
- IQVIA. (2022). Prescription Drug Data Review.
- U.S. Food and Drug Administration. (2014). Xyosted Approval Announcement.
