Last updated: February 25, 2026
What Is the Drug Associated With NDC 60687-0883?
NDC 60687-0883 is identified as Xyosted (testosterone enanthate), a prescription injectable used for testosterone replacement therapy (TRT) in adult males with hypogonadism. It is administered via intramuscular injections typically once weekly.
Market Landscape Overview
Approved Indications and Usage
- Testosterone deficiency in adult males.
- Replacement therapy for low testosterone levels.
- Market size driven by aging male population and diagnoses of hypogonadism.
Key Competitors
- AndroGel (AbbVie) – Top-selling topical testosterone gel.
- Testim (Endo Pharmaceuticals) – Testosterone gel.
- Axiron (Eli Lilly) – Topical testosterone solution.
- Depot-Testosterone (Pfizer) – Injectable testosterone.
Treatment Trends
- Shift towards less invasive options: gels, patches.
- Growing acceptance of injectables like testosterone enanthate for lower frequency administration.
- Increased diagnosis rates linked to aging population.
Regulatory Status
- Filed and approved via FDA’s 505(b)(2) pathway.
- Classed as a Schedule III controlled substance due to abuse potential.
Market Size and Demand Projections
| Parameter |
2022 |
2023 |
2024 |
CAGR (2023–2028) |
| Global TRT Market Value |
$3.5 billion |
$3.65 billion |
$3.82 billion |
6% |
| U.S. TRT Market Share |
65% |
67% |
69% |
— |
| Injectable Testosterone Market Share |
20% |
22% |
25% |
— |
Market growth driven mainly by increasing aging male population and rising diagnostics of hypogonadism.
Pricing Analysis
Current Price Range
- Per-dose cost of testosterone enanthate injections varies between $50 and $100 in the U.S.
- Price fluctuation depends on dosage, supplier, pharmacy discounts, and insurance coverage.
Wholesale Acquisition Cost (WAC)
- Estimated at $20–$40 per 1 mL vial (10 or 100 mg/mL concentration).
- Typically, patients administer 100–200 mg weekly.
Average Patient Cost
- Out-of-pocket costs range between $25 and $75 per injection.
- Insurance coverage reduces patient expenses, but copayments vary.
Price Volatility Factors
- Generic availability influences pricing downward.
- Pharmacy benefit managers (PBMs) negotiate drug prices.
- Competition with other formulations impacts pricing strategies.
Price Projection (Next 5 Years)
| Year |
Estimated Price per 1 mL Vial |
Notes |
| 2023 |
$25–$40 |
Current range, influenced by market competition and generic entry. |
| 2024 |
$23–$38 |
Slight decline expected as generics penetrate further. |
| 2025 |
$22–$36 |
Competitive pressures and manufacturing efficiencies. |
| 2026 |
$21–$34 |
Continued price stabilization; potential for minor reductions. |
| 2027 |
$20–$32 |
Possible price ceiling due to generic saturation. |
Key Drivers of Price Trends:
- Increased generic competition will likely lead to further downward pressure.
- Manufacturing cost reductions.
- Regulatory changes or patent expirations.
- Greater market adoption may stabilize prices.
Regulatory and Policy Impact
- FDA's encouragement of biosimilar and generic insulin markets could set a precedent for testosterone formulations.
- Policy shifts towards cost-effective therapies may favor generic injectable testosterone over branded products.
- Controlled substance regulation may impact supply chains and pricing.
Strategic Implications
- Companies entering this space should plan for declining prices driven by generics.
- Higher-margin opportunities may exist with branded formulations or novel delivery methods.
- Patent considerations and exclusivity periods are critical for pricing control.
Key Takeaways
- The TRT market is expanding, with injectables like testosterone enanthate representing a significant segment.
- Current prices range between $25 and $40 per vial, with potential declines over the next five years.
- Market growth is driven by demographic shifts and increased diagnoses.
- Generic entries will exert downward pressure on prices.
- Companies should consider regulatory landscape and patent status to optimize market positioning.
FAQs
1. Will prices for NDC 60687-0883 decline significantly in the next five years? Yes. The entry of generic products is expected to depress prices, especially from 2024 onwards.
2. What factors influence the variation in patient out-of-pocket costs? Insurance coverage, pharmacy discounts, and negotiated rates with PBMs influence out-of-pocket expenses.
3. How does the competitive landscape affect pricing? Increased competition from generics and biosimilars drives prices downward while branded products may maintain premium pricing.
4. Are there emerging therapies that could replace injectable testosterone? Alternatives such as gels, patches, and nasal gels are gaining market share due to ease of use, but injectables remain relevant for specific patient groups.
5. How do regulatory policies influence the price projections? Policies promoting biosimilar approval and cost containment typically lead to lower prices via increased competition.
References
[1] MarketWatch. (2023). Testosterone Replacement Therapy Market Size & Trends.
[2] IQVIA. (2023). Prescription Drug Trends and Market Share Reports.
[3] U.S. FDA. (2022). Testosterone and related products: regulatory updates.
[4] EvaluatePharma. (2023). Global pharmaceutical market forecasts.
[5] Kaiser Family Foundation. (2022). Prescription drug costs and insurance coverage stats.
