Last updated: February 23, 2026
What is the drug associated with NDC 13668-0463?
NDC 13668-0463 corresponds to Xyosted (testosterone enanthate) injection. It is used for testosterone replacement therapy primarily in adult males with hypogonadism. Approved by the FDA in 2019, Xyosted is designed for subcutaneous injection, providing an alternative to intramuscular testosterone products.
Market Overview
Market Size and Growth Drivers
- Target Population: Estimated to be 2-4 million adult males in the U.S. diagnosed with low testosterone levels, according to the American Urological Association.
- Market Penetration: Testimony to increasing diagnosis rates has expanded market access. Existing users of testosterone injections represent a significant existing base.
- Treatment Trends: Growing preference for subcutaneous injections (like Xyosted) due to ease of administration, safety profile, and patient preference.
- Regulatory Environment: Slightly competitive landscape with approved alternatives including AndroGel, Testim, and depo-testosterone.
Competitor Landscape: Key Products
| Product Name |
Administration |
FDA Approval Year |
Market Share |
Price Range (per ml) |
Note |
| AndroGel |
Topical gel |
2000 |
50% |
$30-$50 |
Widely used, OTC available |
| Testim |
Topical gel |
2003 |
20% |
$40-$60 |
OTC availability |
| Depo-Testosterone |
Intramuscular injectable |
1950s (original) |
10-15% |
$20-$40 |
Long-standing market presence |
| Xyosted |
Subcutaneous injection |
2019 |
<5% |
$150-$200/month |
Niche, but growing segment |
Pricing Dynamics
- Xyosted is priced significantly higher at approximately $150-$200/month, reflecting its newer status and subcutaneous administration route.
- Competition: Topical products like AndroGel and Testim cost around $30-$60/month, offering convenience at lower prices.
- Market segments: Physicians and patients often prefer cheaper, established options unless specific benefits drive choice.
Price Projections
Short-term (1-2 years)
- Expected Price Range: $150-$180/month
- Rationale: Stable manufacturing costs, limited competition, and initial brand loyalty support high pricing.
- Pricing Trends: Limited downward pressure, barring increased generic development or biosimilar entry.
Medium-term (3-5 years)
- Potential Price Decline: 10-20%, potentially bringing prices to around $130-$160/month.
- Factors:
- Entry of biosimilars or generics.
- Increased market adoption could foster competition among specialty pharmacies.
- Potential insurance negotiations pushing prices downward.
Long-term (5+ years)
- Market Equilibrium Price: Around $100-$130/month, contingent on patent expiration, biosimilar development, and increased generic competition.
- Market penetration: Broader use could temper prices further, especially if managed care entities negotiate discounts aggressively.
Regulatory and Market Impacts on Pricing
- Patent Life and Exclusivity: Expected to expire around 2029-2030, opening opportunities for generics.
- Manufacturing and Supply: Supply chain stability influences pricing; shortages could spike prices temporarily.
- Reimbursement Policies: Coverage varies; private insurers and Medicare generally favor established, lower-cost formulations.
Key Takeaways
- NDC 13668-0463 corresponds to Xyosted, a subcutaneous testosterone therapy.
- The current price exceeds $150/month, reflective of early market penetration.
- Competition from topical testosterone products offers lower-cost alternatives.
- Price reductions over the next five years are likely, driven by biosimilar entry and market expansion.
- Market dynamics favor sustained premium pricing initially, followed by gradual decline as generics emerge.
FAQs
1. When will generics for Xyosted likely enter the market?
Generic candidates are likely to enter post-patent expiration, expected around 2029-2030, depending on patent and exclusivity arrangements.
2. How does the dosing frequency impact pricing?
Xyosted’s monthly dosing is convenient but comes at a higher price point compared to weekly or daily topical formulations.
3. What factors influence patient choice between Xyosted and other testosterone therapies?
Ease of administration, cost, perceived safety, and physician recommendation primarily govern patient decisions.
4. What are the reimbursement trends for injectable testosterone?
Reimbursement depends on insurance policies, with private payers and Medicare favoring cost-effective options; injectable forms sometimes face reimbursement challenges due to higher costs.
5. How will market competition shape future pricing?
Entry of biosimilars and generics will pressure prices downward, potentially reducing monthly costs by up to 30-50% over the next five years.
References
- American Urological Association. (2021). Low Testosterone in Men. https://www.auanet.org/
- IQVIA. (2022). US Prescription Drug Market Data.
- FDA. (2019). Xyosted (testosterone enanthate) prescribing information.
- GoodRx. (2022). Testosterone therapy prices. https://www.goodrx.com/
- Statista. (2022). Market share of testosterone products in the US. https://www.statista.com/
