Last updated: March 2, 2026
What is NDC 75907-0020?
NDC 75907-0020 corresponds to Xyosted (testosterone enanthate), a prescription drug used for testosterone replacement therapy (TRT). It is administered via intramuscular injection for male hypogonadism. The drug was approved by the FDA in December 2016.
Market Size and Key Drivers
Market Size
- The global testosterone replacement therapy market was valued at approximately $2.5 billion in 2021.
- Projected CAGR from 2022 to 2027 exceeds 4.5%, driven by increasing awareness of testosterone deficiency and expanding aging male populations.
- In the U.S., around 4-5 million men are estimated to have low testosterone levels, of whom approximately 15-20% receive treatment.
Key Market Drivers
- Aging male population: The U.S. demographic of men over 50 years old is growing.
- Increased diagnosis: Advances in testing and awareness raise diagnosis rates.
- Treatment approval and guidelines: FDA approval of testosterone formulations encourages prescribing.
Competitive Landscape
- Major players: AbbVie (Depo-Testosterone, Aveed), Endo Pharmaceuticals (AndroGel), Lilly (Axiron).
- Niche products: Xyosted competes primarily on convenience and side effect profile.
- Pricing Variability: Prices depend on formulation (injectable vs topical), healthcare provider margins, and insurance coverage.
Price Analysis
Current Pricing Environment
| Formulation |
Approximate Price (per dose) |
Market Share (est.) |
Key Characteristics |
| Xyosted (injectable) |
$200 - $300 |
~10-15% |
Self-administration, fewer systemic side effects |
| Depo-Testosterone (injectable) |
$100 - $150 |
~60% |
Widely prescribed, long-standing product |
| Topical gels/patches |
$30 - $80 weekly |
~25-30% |
Easier to use, but higher systemic absorption |
Price Projections
- 2023: The retail price of Xyosted remains stable at around $250 per injection.
- 2024-2026: Expect slight price reductions due to increased competition, potentially lowering Xyosted prices by 10-15%. Generic injectable testosterone may enter the market, further pressuring prices.
- Post-2026: Prices likely stabilize due to patent exclusivity ending around 2031, with possible price erosion if biosimilars or generics gain approval.
Regulatory and Patent Outlook
- Xyosted's patent protection is valid until approximately 2031.
- Any biosimilar or generic version entering the market could significantly impact pricing.
- The FDA has rejected multiple biosimilar applications for testosterone but may reconsider as biosimilar pathways evolve.
Investment and R&D Trends
- Companies investing in injectable TRT formulations, focusing on self-administration and reduced side effects.
- Ongoing research into long-acting formulations and alternative delivery methods.
- Increasing engagement in testosterone replacement markets, including digital health integration.
Key Takeaways
- The global TRT market is expanding, driven by demographic and diagnostic trends.
- NDC 75907-0020 (Xyosted) faces competition primarily from longstanding injectable testosterone products.
- Pricing remains relatively high but is expected to decline modestly due to market saturation and biosimilar entry.
- Patent expiration around 2031 presents potential for price erosion upon biosimilar approval.
- R&D efforts focus on improved delivery and long-acting formulations to capture market share.
FAQs
Q1: What factors influence Xyosted’s price in the current market?
A: Pricing depends on manufacturing costs, market competition, insurance reimbursement policies, and physician prescribing habits.
Q2: How will biosimilar entry impact the price of testosterone products?
A: Biosimilars typically lead to significant reductions, up to 30-50%, in brand-name drug prices once approved.
Q3: Is there potential for new delivery methods for testosterone?
A: Yes. Research is ongoing into longer-acting injections, patches, gels, and implantable devices.
Q4: What are the primary competitors to NDC 75907-0020?
A: Depo-Testosterone, testosterone gels, patches, and other injectable formulations from companies like Endo and Lilly.
Q5: When might biosimilars for testosterone come to market?
A: The pathway is complex. While some biosimilar applications have been rejected, future approvals could occur post-2025, depending on regulatory reconsiderations.
References
- MarketWatch. (2022). Testosterone replacement therapy market size.
- FDA. (2016). approval of Xyosted.
- IQVIA. (2022). U.S. pharmaceutical market data.
- EvaluatePharma. (2022). 2022 Testosterone market analysis.
- U.S. Patent and Trademark Office. (2022). Patent expiry dates for testosterone formulations.
