Last updated: February 13, 2026
What is NDC 70700-0114?
NDC 70700-0114 identifies a drug product listed in the FDA’s National Drug Code Directory. This specific NDC refers to Xyosted (testosterone enanthate), a long-acting testosterone injection approved for testosterone replacement therapy (TRT) in adult males with hypogonadism.
Market Size and Competitors
Market Overview:
- The global testosterone replacement therapy market was valued at approximately $1.6 billion in 2022.
- The U.S. accounts for roughly 80% of this market.
- Annual growth expected at 3.5% from 2023 to 2028.
Key Players & Competition:
| Product Name |
Brand / Manufacturer |
Dosage Forms |
Price Range (per 10 mL vial) |
| Xyosted |
TherapeuticsMD |
Injections |
$200 - $250 |
| AndroGel |
AbbVie |
Gel |
$500 - $700 per 100g |
| Testim |
Lupin |
Gel |
$300 - $450 per tube |
| Axiron |
Lilly |
Topical solution |
$420 - $600 per bottle |
Xyosted's pricing is competitive relative to other intramuscular testosterone formulations. Its long-acting nature differentiates it from daily gels and topical options.
Pricing Trends and Projections
Historical Price Data:
- Since FDA approval in 2015, Xyosted has maintained a stable price range, around $200–$250 per 10 mL vial.
- Price stabilization is common in this market due to high competition and regulatory oversight.
Factors Influencing Future Price-Setting:
- Patent and Exclusivity: Xyosted has no current patent barriers after its initial exclusivity period, potentially exposing it to biosimilar competition.
- Manufacturing Costs: Expected to decline due to process optimizations.
- Market Penetration: Increasing adoption in primary care practices could stabilize or reduce prices due to economies of scale.
- Reimbursement Landscape: insurer coverage favors established formulations; new entrants or biosimilars could pressure prices downward.
Projected Price Range (2023-2028):
| Year |
Price Range (per 10 mL vial) |
Justification |
| 2023 |
$200 – $250 |
Current stability; competition remains moderate |
| 2024 |
$200 – $240 |
Slight decline expected with increased competition |
| 2025 |
$190 – $230 |
Biosimilar entries and market saturation effects |
| 2026 |
$180 – $220 |
Price reductions driven by biosimilar and decreased costs |
| 2027 |
$180 – $210 |
Market stabilization at lower price points |
| 2028 |
$170 – $200 |
Market maturity; pricing driven by biosimilar competition |
Regulatory and Market Expansion Prospects
- Expansion into markets outside the US could alter pricing dynamics.
- Biosimilar development is advancing; FDA approvals could be expected within 3-4 years, likely pressuring prices downward.
- Reimbursement policies continue to evolve, influencing access and pricing.
Key Market Drivers
- Growing incidence of hypogonadism: An aging male population increases demand.
- Preference for long-acting formulations: Patient convenience favors injectable products like Xyosted.
- Provider familiarity: Established usage patterns favor market retention.
Potential Challenges
- Patent expirations and biosimilar entrants.
- New legislation affecting compounding and off-label distribution.
- Competitive pricing pressures from alternative formulations.
Summary
- The current market price for NDC 70700-0114 (Xyosted) is approximately $200–$250 per 10 mL vial.
- Market forces project a slight downward trend over the next five years due to biosimilar competition and cost-saving measures.
- The long-term outlook indicates prices stabilizing around $170–$200 per vial by 2028, barring significant regulatory or market disruptions.
Key Takeaways
- Xyosted maintains a competitive pricing position primarily due to its formulation and market segment.
- Biosimilar development portends price reductions within the next 3-4 years.
- Market growth is driven by an aging population and preference for injectable TRT.
- Regulatory factors and reimbursement trends will influence price stability.
- Price projections assume steady market conditions; unforeseen patent disputes or legislation could alter these estimates.
FAQs
1. What are the primary competitors to Xyosted?
Competitors include topical gels like AndroGel and Testim, as well as other injectable testosterone products like Delatestryl and testosterone cypionate.
2. How does biosimilar competition impact prices?
Biosimilar entries typically cause prices to decrease by 20–40%, depending on market acceptance and regulatory approval timelines.
3. Are there upcoming regulatory changes that could affect pricing?
Potential changes in biosimilar regulation, patent law, and reimbursement policies could influence prices but are currently uncertain.
4. How does market growth affect pricing?
Market growth driven by demographic trends can sustain or increase demand, maintaining stability or slightly reducing prices due to scale effects.
5. What is the regional outlook for this drug?
While primarily marketed in the U.S., expanding into international markets often involves different pricing environments, potentially altering global pricing trends.
References
- Future Market Insights, “Testosterone Replacement Therapy Market Size & Share Analysis,” 2022.
- IQVIA, “U.S. Prescription Drug Spending Analysis,” 2022.
- FDA Drug Approvals and PATENT Data, 2022.
- MarketWatch, “Testosterone Market Trends,” 2023.
