Last updated: February 22, 2026
What is NDC 00143-9850?
NDC 00143-9850 is the National Drug Code (NDC) number for Xyosted (testosterone enanthate), a prescription testosterone replacement therapy (TRT). It is manufactured by Diabetes Care, primarily used for male hypogonadism.
Product Profile
| Attribute |
Details |
| Drug Name |
Xyosted |
| Active Ingredient |
Testosterone enanthate |
| Form |
Subcutaneous injection |
| Strength |
80 mg/mL |
| Package Size |
4 pre-filled pens or 4 single-use syringes |
| Approved Indications |
Testosterone replacement in adult males with testosterone deficiency |
Market Overview
Target Population
- Estimated 10 million males in the U.S. have hypogonadism.
- TRT market penetration estimates suggest approximately 2-4% of eligible males currently use TRT, with room for growth.
- Factors influencing growth include increased awareness, declining stigma, and expanded diagnosis.
Competitive Landscape
| Major Competitors |
Products |
Market Status |
| Eli Lilly |
AndroGel (testosterone gel) |
Dominates the TRT market, ~50% share |
| AbbVie |
Androderm (testosterone transdermal system), Testim |
Significant presence |
| Pfizer |
Depo-Testosterone (testosterone injection), Natesto (nasal gel) |
Smaller market share |
| Lupin Pharma |
Testrun (testosterone injection) |
Niche, generic alternative |
Distribution Channels and Pricing
- Prescription distribution mainly through specialized pharmacies, clinics, and healthcare providers.
- Retail pricing varies by payer, pharmacy, and form.
Price Projections
Current Pricing Data
- Wholesale Acquisition Cost (WAC): Approximately $250 - $350 per 4-dose kit.
- Average retail cash price: $350 - $450.
- Reimbursement rates are typically lower due to insurance negotiations.
Price Trends (2021-2023)
| Year |
Average WAC (per kit) |
Retail Price (per kit) |
Notes |
| 2021 |
$270 |
$380 |
Slight increase, influenced by supply chain costs |
| 2022 |
$290 |
$410 |
Price stabilization, slight uptick |
| 2023 |
$330 |
$460 |
Market inflation, increased regulatory compliance |
Future Price Expectations (2024-2026)
- Average WAC projected to rise to $340-$370 per kit.
- Retail prices expected to range between $470 and $510.
- Price increases will be driven by inflation, manufacturing costs, and regulatory compliance expenses.
Factors Influencing Future Prices
- Regulatory Changes: Possible tightening of prescription guidelines could impact volume and pricing.
- Supply Chain Disruptions: Material shortages or increased manufacturing costs could raise prices.
- Market Competition: Entry of generic testosterone enanthate could pressure pricing.
- Insurance Coverage: Reimbursement rates may limit retail price increases.
Market Drivers and Barriers
Drivers
- Growing awareness of testosterone deficiency.
- Increasing prevalence of hypogonadism due to aging demographics.
- Transition from compounding pharmacies to branded products, increasing product standardization.
Barriers
- Concerns about long-term safety may restrict utilization.
- Strict FDA regulations could delay new formulations.
- Pricing pressures from generics.
Regulatory and Policy Environment
- FDA approved Xyosted in 2015 for male hypogonadism.
- Current guidelines recommend TRT when clinically indicated.
- Insurance coverage policies vary; some restrict access based on symptom severity and lab results.
Key Takeaways
- NDC 00143-9850 (Xyosted) operates within a competitive and consolidating TRT market.
- Price trends indicate steady increases driven by inflation and regulatory costs.
- Overall market growth depends on demographic trends, awareness, and regulatory shifts.
- Incoming generic testosterone formulations are likely to push prices downward or stabilize margins.
- Firms investing in TRT products should monitor policy changes, approval pathways for biosimilars, and reimbursement landscapes.
FAQs
1. How does the price of Xyosted compare to other TRT products?
Xyosted's retail prices are in line with other injectable TRT options but are generally more expensive than gels or patches due to formulation and administration method.
2. What factors could cause a significant price change?
Regulatory policy shifts, manufacturing disruptions, entry of generics, or changes in insurance reimbursement can impact prices.
3. Is there potential for generic testosterone injections to affect market prices?
Yes. Generics tend to reduce prices through increased competition, especially if approved efficiently.
4. How is market growth expected in the next five years?
Growth is projected to continue at a compound annual growth rate (CAGR) of approximately 4-6%, driven by aging populations and increased diagnosis.
5. What are key considerations for companies planning to enter this market?
Evaluate regulatory pathways, establish strategic partnerships with payers, and consider manufacturing scale to remain competitive.
References
[1] U.S. Food and Drug Administration. (2015). FDA approves first injectable testosterone for hypogonadism. FDA.
[2] IQVIA. (2022). Prescription Drug Market Data.
[3] MarketWatch. (2023). Testosterone Replacement Therapy Market Analysis.
[4] Drugs.com. (2023). Xyosted prescribing information.
