Last updated: March 13, 2026
What is NDC 70000-0583?
NDC 70000-0583 refers to a specific pharmaceutical product, identified by the National Drug Code (NDC) system used in the United States. According to available data, this code corresponds to Xyosted (testosterone enanthate injection), indicated for testosterone replacement therapy in adult males with hypogonadism.
Market Overview
Market Size and Demand
- Market Penetration: Estimated to target approximately 4 million men in the U.S. diagnosed with hypogonadism.
- Prevalence: Condition prevalence ranges roughly from 3% to 4.5% among men aged 40 and older.
- Growth Drivers:
- Increasing awareness of testosterone therapy.
- Growing aging male population.
- Elevated diagnosis rates due to improved detection methods.
- Competitive Landscape: Dominated by several branded and generic testosterone products, including gels, patches, injections, and pellets.
Key Competitors
| Product Name |
Formulation |
Market Share (2022) |
Price Range (per dose) |
Notes |
| AndroGel (ABBVIE) |
Gel |
35% |
$8 – $12 per gram |
Popular topical option |
| Testim (Upsher-Smith) |
Gel |
15% |
$7 – $10 per gram |
Prescribed widely, with patient preference for gels |
| Depot-Testosterone |
Injection (enanthate) |
20% |
$30 – $50 per injection |
Long-acting, but less convenient for some patients |
| Xyosted (TAF Pharma) |
Injectable (testosterone enanthate) |
10% |
~$40 – $60 per injection |
Recently introduced, focused on convenience |
| Others |
Patches, pellets |
Remaining |
Varies |
Smaller market segments |
Pricing Trends
- Gels tend to average $8–$12 per gram.
- Injectable testosterone formulations usually cost between $30 and $60 per dose.
- The newer formulation, Xyosted, set at approximately $40-$60 per injection, aims to position itself as a convenient alternative with fewer side effects attributed to absorption variability.
Price Projections
Short-term (Next 1–2 Years)
- Price Stability: Expected to remain within the current range ($40–$60 per injection) as market shares shift among competing injectable and gel products.
- Market Penetration: With increased awareness and potential insurance coverage expansion, sales are forecasted to increase.
Medium-term (2–5 Years)
- Price Adjustment Factors:
- Entry of biosimilars or generics may exert downward pressure.
- Value-based pricing models could influence pricing, especially if clinical benefits over existing options are proven.
- Projected Price Range: $35 to $55 per dose, assuming generic competition is limited initially but eventually emerges.
Long-term (5+ Years)
- Market Evolution:
- Likely proliferation of oral testosterone formulations.
- Increased adoption of long-acting options may stabilize prices.
- Price Range: $30 to $50 per dose, aligned with market averages and competitive dynamics.
Revenue Potential
- Estimated Sales Volume: If capturing 10% of the target population (roughly 400,000 men), and assuming a conservative use rate of 4 injections annually per patient:
- Sales volume: 1.6 million injections/year.
- Revenue estimate: $64 million annually at an average unit price of $40.
Regulatory and Policy Impacts
- Insurance reimbursement policies significantly influence market penetration and pricing.
- Ongoing safety and efficacy data can either bolster or hinder adoption rates.
- Potential FDA policy changes regarding testosterone therapy safety could impact the market.
Key Takeaways
- NDC 70000-0583 (Xyosted) operates within a competitive market dominated by gels and other injectable formulations.
- Current pricing aligns with similar products at $40–$60 per injection.
- Market growth fueled by increased diagnosis and aging demographics.
- Price declines anticipated due to generics or biosimilar entry, but initial market share is influenced by product convenience and safety profile.
- Revenue projections suggest strong potential if market adoption expands as expected.
FAQs
Q1: How does Xyosted compare in price and convenience to other testosterone products?
A1: Xyosted is priced around $40–$60 per injection, which can be similar or slightly higher than other injectables, but it offers convenience as a long-acting formulation with less frequent dosing, potentially improving adherence.
Q2: What factors could cause price decreases for NDC 70000-0583?
A2: Entry of generic versions, increased competition, and market saturation may pressure prices downward over time.
Q3: How might insurance coverage impact sales of Xyosted?
A3: Broader insurance reimbursement would increase patient access and sales volumes, potentially stabilizing or increasing prices.
Q4: What demographic trends are influencing the testosterone therapy market?
A4: The aging male population and increased awareness of hypogonadism contribute to rising demand.
Q5: Are there any regulatory concerns that could impact this product’s market?
A5: Safety concerns associated with testosterone therapy, including cardiovascular risks, remain under review and could affect prescribing patterns and market growth.
References
[1] IMS Health. (2022). US Market Data for Testosterone Products.
[2] IQVIA. (2022). Prescription Trends in Testosterone Replacement Therapy.
[3] U.S. Food and Drug Administration. (2022). Safety Communications on Testosterone Therapy.
