Last updated: July 27, 2025
Introduction
NDC 60687-0622 corresponds to Xyosted (testosterone enanthate injection), a branded hormonal therapy primarily indicated for testosterone replacement therapy (TRT) in adult males diagnosed with hypogonadism. As the demand for TRT continues to rise, driven by increased awareness and diagnosis of testosterone deficiencies, understanding the market landscape and pricing outlook for Xyosted is vital for stakeholders including pharmaceutical companies, healthcare providers, payers, and investors.
Market Landscape
Therapeutic Demand and Patient Demographics
Testosterone deficiency affects an estimated 2-4 million men in the United States alone, with prevalence increasing in aging populations [1]. With lifestyle factors and chronic health conditions contributing to hypogonadism, the demand for testosterone therapies like Xyosted persists. Physicians favor injectable formulations due to consistent serum levels and ease of administration, positioning testosterone enanthate as a preferred modality among options such as gels, patches, and pellets.
Competitive Environment
Xyosted competes with numerous TRT formulations, notably:
- Transdermal gels (e.g., AndroGel, Testim)
- Transdermal patches (e.g., Androderm)
- Implantable pellets (e.g., Testopel)
- Other injectable testosterone products (e.g., testosterone cypionate, testosterone propionate)
While gels and patches offer convenience, injectables like Xyosted are often preferred for their biweekly dosing and stable plasma testosterone levels. The market leader remains AndroGel, with a significant share, but injectables constitute an increasing segment attributed to their efficacy and patient preference.
Regulatory and Reimbursement Trends
Since its FDA approval in 2014, Xyosted has gained a niche market. However, reimbursement policies, insurance coverage, and Medicare/Medicaid formularies influence prescribing patterns. The relatively high cost of branded injectables underscores the importance of patent protections and potential biosimilar entries, which could disrupt the market dynamics.
Pricing Analysis
Current Pricing Landscape
As of late 2022, the average wholesale price (AWP) for Xyosted ranges between $1,200 to $1,400 per month (per 2 mL vial, 75 mg/mL), depending on pharmacy discounts and insurance negotiations [2]. The actual out-of-pocket cost for patients varies significantly based on insurance and copayment structures.
Cost Comparison with Competitors
- Gels: Typically $300–$600/month, but with higher adherence issues.
- Other Injectables: Testosterone cypionate vials approximate $50–$100 per dose, but require multiple injections and may involve clinic administration or multiple prescriptions.
Given its branded status, Xyosted's pricing reflects its premium positioning, emphasizing a balance of efficacy, convenience, and reduced injection frequency (biweekly versus weekly or multiple injections for other formulations).
Market Projections
Factors Influencing Price Trends
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Patent Life and Generic Entry:
Xyosted's patent protection is expected to expire within the next 2-3 years, opening opportunities for biosimilar or generic competitors that could significantly reduce prices [3].
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Biologics and Biosimilars:
As testosterone enanthate formulations potentially qualify as biosimilars, market entry could drive competition, leading to price erosion.
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Regulatory Dynamics:
Regulatory pathways for biosimilars are evolving, affecting future pricing strategies. US biosimilar approval pathways have been streamlined, fostering increased competition.
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Market Penetration and Adoption Rates:
Increasing awareness of hypogonadism and expanding diagnosis may sustain demand but may plateau if generic competition reduces costs.
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Insurance Coverage and Reimbursement Policies:
Wide insurance adoption and favorable pricing negotiations could stabilize or decrease net costs for payers and patients over the next 3-5 years.
Price Projection Outlook (2023–2028)
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Short-term (2023–2025):
Prices are expected to remain relatively stable, with minor reductions (~5-10%) driven by institutional negotiated discounts. The absence of immediate biosimilar competition maintains premium pricing.
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Mid-term (2025–2028):
With patent expiration and biosimilar approvals, prices for testosterone enanthate formulations could decline by 40–60%, aligning with trends observed in other biologic classes post-patent expiry [4].
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Long-term:
Market consolidation and increased biosimilar competition may stabilize prices at approximately $300–$600/month, comparable to existing generic injectables, expanding patient access.
Key Market Risks and Opportunities
Risks
- Patent expiry leading to generic competition.
- Potential regulatory restrictions on compounded testosterone.
- Reimbursement limitations that could lower provider prescribing incentives.
- Market saturation as diagnosis and treatment rates plateau.
Opportunities
- Development of long-acting formulations or novel delivery systems.
- Strategic collaborations with biosimilar manufacturers.
- Expansion into emerging markets with growing testosterone deficiency awareness.
- Integrated telehealth platforms to streamline treatment access.
Conclusion
NDC 60687-0622, representing Xyosted, occupies a defined niche within the testosterone replacement therapy landscape. Its current premium pricing reflects unique formulation benefits but faces significant downward pressure once patents expire. The evolving biosimilar environment and regulatory landscape are primary drivers of future price trajectories. Stakeholders must monitor patent statuses, regulatory changes, and market acceptance to align strategies effectively.
Key Takeaways
- Xyosted commands a premium price (~$1,300/month), reflecting its branded injectable testosterone enanthate formulation.
- Market growth hinges on increased diagnosis of testosterone deficiency, with injectables maintaining preference among certain patient subsets.
- Patent expiry and biosimilar approvals within the next 2–3 years are likely to precipitate substantial price reductions.
- Competitive dynamics, reimbursement policies, and evolving regulatory standards will shape future pricing and market share.
- Manufacturers should prepare for biosimilar entry by optimizing costs and increasing value propositions to sustain profitability.
FAQs
1. What factors influence the pricing of testosterone injectable drugs like NDC 60687-0622?
Pricing is influenced by manufacturing costs, formulation complexity, patent status, market competition, insurance reimbursement rates, and pharmacy discounts.
2. How does biosimilar entry impact the market for testosterone therapies?
Biosimilar entry generally reduces prices through increased competition, expands access, and prompts existing manufacturers to adjust pricing and marketing strategies.
3. Are there any recent regulatory changes affecting testosterone injectable drugs?
Regulatory agencies are focusing on ensuring safety and efficacy, with increased oversight on compounded testosterone and incentivizing biosimilar development, which may influence market entry and pricing.
4. What is the outlook for patient affordability of testosterone injectable therapies?
Post-patent expiry and biosimilar introduction will likely improve affordability, especially for insurance-covered patients, potentially reducing out-of-pocket expenses by up to 60%.
5. How does the demand for testosterone therapy influence future pricing trends?
Rising diagnosis and treatment of hypogonadism sustain demand; however, market saturation and competition will pressure prices downward over time.
References
[1] Corona G, et al. "Prevalence of testosterone deficiency syndrome in men." J Endocrinol Invest. 2018.
[2] GoodRx. "Cost of Xyosted (testosterone enanthate injection)", 2022.
[3] FDA. "Patent Expiry and Biosimilar Pathways," 2022.
[4] IMS Health. "Biologics Market Trends," 2022.
