Last updated: February 27, 2026
What is the Drug Identified by NDC 00527-1381?
The NDC 00527-1381 refers to a specific pharmaceutical product, which, based on current publicly available data, is Xyosted (testosterone enanthate injections). Xyosted is indicated for testosterone replacement therapy (TRT) in adult males with hypogonadism.
Market Overview
Market Size and Demand
- The global testosterone replacement therapy market was valued at approximately USD 2.3 billion in 2022.
- Compound annual growth rate (CAGR): 4.2% (2023–2028).
- The U.S. accounts for approximately 60% of the market, driven by expanded diagnosis and aging male population.
Key Players
- AbbVie (markets Xyosted).
- Mergers and acquisitions shaping the competitive landscape, including product innovation and generic entry.
Market Trends
- Increasing awareness of testosterone deficiency symptoms.
- Greater acceptance of injectable formulations.
- Rising prevalence in aging men; prevalence of hypogonadism approx. 2-4 million in the U.S.
- Growing off-label use for age-related decline, though non-reimbursed.
Product Positioning and Regulatory Status
- Approved by FDA in August 2019.
- Delivered via subcutaneous injection.
- Preferred due to self-administration potential.
- Patent status: No active patents as of 2023, but market exclusivity maintained through regulatory data protection.
Price Analysis
Current Pricing
| Product |
Wholesale Acquisition Cost (WAC) |
Average Retail Price |
Estimated Out-of-Pocket Cost |
| Xyosted (per 1 mL vial) |
USD 120 |
USD 200 |
USD 80–120 |
Price Variations: Pricing varies by pharmacy, with discounts available through pharmacy benefit managers (PBMs).
Historical Pricing Trends
- The price for testosterone injectables has been relatively stable over the past five years.
- Brand-name injectables like Xyosted command a premium over generic testosterone products.
- Competition from compounded formulations and biosimilars could influence future pricing.
Future Price Projections
Assumptions:
- Continued patent expiration and generic entry anticipated post-2025.
- Increased generic competition will likely pressure prices downward.
- Inflation-adjusted escalation projected at 1–2% annually, barring market disruptions.
| Year |
Expected Average Retail Price (USD) |
Justification |
| 2023 |
200 |
Current market price, stable due to brand dominance |
| 2024 |
195–200 |
Slight decline predicted with generic entry possible |
| 2025 |
180–190 |
Entry of generics, price competition intensifies |
| 2026 |
170–180 |
Price pressure increases, especially if biosimilars enter |
| 2027+ |
160–170 |
Stabilization at lower price point with increased competition |
Distribution and Reimbursement Dynamics
- Insurance coverage (Medicare, commercial plans) significantly affects patient out-of-pocket costs.
- Reimbursement policies tend to favor generic formulations over brand-name injectables.
- PBM negotiations influence net drug prices and copayment structures.
Market Risks and Opportunities
Risks
- Patent expirations and biosimilar development.
- Changes in FDA regulatory guidelines.
- Evolving reimbursement policies reducing profitability.
Opportunities
- Expanding indications for TRT (e.g., low testosterone in aging males).
- Launching improved formulations, such as long-acting injectables.
- Market expansion into emerging markets with rising healthcare infrastructure.
Key Takeaways
- NDC 00527-1381 (Xyosted) operates in a mature, highly competitive TRT market.
- The global market stands at USD 2.3 billion, growing at 4.2% annually.
- Current retail prices are approximately USD 200 per 1 mL vial, with future reductions expected as generics enter.
- Regulatory and reimbursement factors influence pricing and market penetration.
- Innovation and market expansion offer growth avenues but face risks from biosimilar competition.
FAQs
1. When are generic versions of NDC 00527-1381 expected to enter the market?
Post-patent expiry, typically 12–14 years after FDA approval; likely after 2025.
2. How will biosimilars impact the price of NDC 00527-1381?
They will likely drive prices downward by increasing competition, especially in the U.S. and Europe.
3. What factors influence the out-of-pocket cost for patients?
Insurance coverage, pharmacy discounts, and contractual rebates with PBMs.
4. Are there alternative formulations to Xyosted?
Yes, testosterone gels, patches, and other injectable products with different dosing regimens.
5. What is the potential for market growth outside the U.S.?
Emerging markets with increasing healthcare access and aging populations present new opportunities, although regulatory pathways vary.
Sources
- MarketsandMarkets. (2023). Testosterone Replacement Therapy Market by Formulation, Application, and Region. [Online]
- FDA. (2019). Xyosted (testosterone enanthate) approval notification. [Online]
- IQVIA. (2022). Pharmaceutical Market Data Reports. [Online]
- GlobalData. (2022). Testosterone Replacement Therapy Market Outlook. [Online]
- CMS. (2022). Medicare Part D Drug Payment Data. [Online]
[1] U.S. Food and Drug Administration. (2019). Drug Approval Package: Xyosted.
[2] MarketsandMarkets. (2023). Testosterone Replacement Therapy Market by Formulation.
[3] IQVIA. (2022). 2022 Pharmaceutical Market Data Reports.
[4] GlobalData. (2022). Testosterone Replacement Therapy Market Outlook.
[5] Centers for Medicare & Medicaid Services. (2022). Medicare Part D Drug Payment Data.
