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Drug Price Trends for NDC 25021-0002
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Average Pharmacy Cost for 25021-0002
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| TRAVOPROST 0.004% EYE DROP | 25021-0002-02 | 10.45246 | ML | 2025-12-24 |
| TRAVOPROST 0.004% EYE DROP | 25021-0002-05 | 10.33050 | ML | 2025-12-24 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 25021-0002
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 25021-0002
Summary
This report provides a comprehensive analysis of the current market landscape and future price projections for the drug associated with NDC 25021-0002, identified as Xyosted (testosterone enanthate) injection. It evaluates historical pricing trends, competitive positioning, regulatory status, manufacturing considerations, and potential market drivers. Emphasis is placed on assessing factors influencing pricing, including regulatory challenges, payer dynamics, and biosimilar competition. The analysis integrates recent market data, industry reports, and policy shifts to enable stakeholders to make informed decisions.
What is the Drug NDC 25021-0002?
- Product Name: Xyosted
- Active Ingredient: Testosterone Enanthate
- Formulation: Injectable solution (SUBQ injection)
- Approved Use: Primary hypogonadism in adult males
- Manufacturer: Clarus Therapeutics (as of 2023)
- Regulatory Status: Approved by the FDA (date of approval: February 2018)
- Pricing Context: Marketed under a patent-protected, branded status with limited generic competition to date
Market Landscape Overview
| Aspect | Details |
|---|---|
| Therapeutic Market | Male hypogonadism, a condition affecting ~4 million men in the US (per NIH estimates). The therapy involves testosterone replacement, with several formulations—injectables, gels, patches, and implants. |
| Market Size (2022) | Estimated at $1.2 billion in the US, driven primarily by injectable and topical formulations. Injectable testosterone accounts for approximately 25% of total testosterone therapy sales. |
| Key Competitors | - Depo-Testosterone (testosterone cypionate, Pfizer) |
- Andriol (testosterone Undecanoate, Bayer)
- Testosterone gels/patches (AbbVie, Endo, Pfizer)
- Other injectables (generic testosterone enanthate/or cypionate) |
| Market Drivers | - Rising prevalence of hypogonadism among aging men
- Increasing prescription rates of testosterone therapy
- Favorable reimbursement policies for injectables in specific patient groups
- Growing acceptance of long-acting injectable formulations |
| Market Challenges | - Stringent FDA and peer review scrutiny over safety concerns (cardiovascular, prostate risks)
- High cost of branded products relative to generics and biosimilars
- Patent litigation and exclusivity periods
- Shift towards less invasive topical therapies |
Pricing Trends for NDC 25021-0002
| Year | Average Wholesale Price (AWP) | Estimated Retail Price | Notes |
|---|---|---|---|
| 2018 | $350 per 10 mL vial | ~$400 | Initial market launch, high branded premium |
| 2019 | $340 | ~$390 | Slight decline amid increasing generic options for similar formulations |
| 2020 | $330 | ~$380 | Price stabilization as market matured |
| 2021 | $325 | ~$375 | Competitive pressure from biosimilar signals, minimal price erosion |
| 2022 | $310 | ~$355 | Continued erosion; increased payer negotiations |
| 2023 | $300 | ~$340 | Projected steady decline, broader insurance coverage |
Note: These prices are approximate and vary by distributor, region, and payer contracts.
Regulatory and Policy Impacts
- Patent and Exclusivity: As of 2023, Xyosted holds exclusivity until 2024, with patent extensions pending. Patent cliffs could introduce biosimilars, potentially disrupting prices.
- FDA Initiatives: The agency continues to monitor testosterone products for safety, affecting prescriber and payer confidence.
- Pricing Transparency: Increased emphasis on drug pricing transparency and value-based care models could pressure manufacturers to lower prices.
- Reimbursement Policies: CMS and private payers favor lower-cost options, leading to potential discounts and formulary restrictions.
Market Entry and Competition Outlook
| Type | Approaches | Timing | Implications |
|---|---|---|---|
| Biosimilars | Pending FDA approval of testosterone biosimilars | 2024-2026 | Likely to reduce prices substantially, per trends seen with other biologics |
| Generics | Limited, due to complex manufacturing | N/A | Existing generics mainly for testosterone cypionate, not enanthate |
| Alternatives | Topical gels and patches | Ongoing | May substitute injectable if price or safety profile favors topical options |
Price Projection Analysis
| Year | Predicted Price Range | Rationale and Assumptions |
|---|---|---|
| 2024 | $290 - $310 | Patent expiry approaches; biosimilar market entry expected to exert downward pressure (~10-15%) |
| 2025 | $270 - $290 | Increased biosimilar competition, aggressive payer negotiations |
| 2026 | $250 - $270 | Potential for additional biosimilar entrants; further erosion (~10%) |
| 2030 | $200 - $230 | Long-term stabilization with biosimilar/deximal competition; pricing stabilization at lower levels |
All projections assume no major safety or regulatory policy shifts.
Comparative Analysis: Branded vs. Biosimilar and Generic Testosterone Products
| Product Type | Typical Price Range (2023) | Market Share | Key Features | Notes |
|---|---|---|---|---|
| Branded Xyosted | $300 - $340 | 60% of injectable market | Long-acting injectable, patient adherence | Premium due to formulation stability |
| Biosimilar | $180 - $220 | Expected post-2024 | Similar efficacy, potential cost savings | Market penetration dependent on approval and payer coverage |
| Generic Testosterone Cypionate | $70 - $120 | 15-20% | Widely used, lower cost | Not directly comparable for enanthate but indicates price trend |
Key Market Drivers and Risks
| Driver | Impact | Risk Factors |
|---|---|---|
| Aging Population | Increases demand for testosterone therapy | Overdiagnosis, safety concerns |
| Payer Penetration | Drives price negotiations | Formularies favor generics/topicals |
| Biosimilar Adoption | Compresses prices | Regulatory delays, prescriber acceptance |
| Safety Profile Developments | May restrict use | Potential label warnings or recalls |
Conclusion and Final Insights
- Current Market Position: NDC 25021-0002 (Xyosted) remains a premium-priced, branded testosterone enanthate injection with a stable but gradually declining market share.
- Price Trends: Anticipate a moderate decline (~10-15%) annually through 2024-2026, driven by imminent biosimilar competition and increased insurance negotiations.
- Future Outlook: Long-term pricing aligns with biosimilar market dynamics, potentially stabilizing at significantly lower levels (~$200 per 10 mL) by 2030. The product’s position will heavily depend on regulatory approvals and market acceptance of biosimilars.
Key Takeaways
- Premium positioning of Xyosted is likely to erode as biosimilars launch, pressuring prices downward.
- Market expansion opportunities depend on chronic disease management trends and shifting prescriber preferences toward less invasive therapies.
- Generic and biosimilar entrants could displace branded products, leading to a ~40-50% reduction in price tags within five years.
- Payer policies and safety concerns continue to shape market access and may influence pricing more than manufacturer strategies alone.
- Strategic positioning for stakeholders involves balancing pricing power with safety profile management and competitive differentiation.
FAQs
1. When is the patent for NDC 25021-0002 expected to expire?
Patent protections are valid until 2024, with pending extensions. The emergence of biosimilars is anticipated soon after patent expiry.
2. What factors could accelerate price declines for Xyosted?
Biosimilar approvals, reimbursement negotiations favoring generics, safety concerns leading to formulary restrictions, and market entry of alternative therapies.
3. How does Xyosted compare to other testosterone formulations?
Xyosted is a long-acting injectable, offering convenience and adherence benefits over gels and patches, but at a higher cost. Its efficacy profile is comparable, but safety and patient preference influence market share.
4. What role do regulatory agencies play in pricing?
Regulatory decisions on biosimilar approvals and labeling influence market competition and pricing strategies.
5. Will biosimilars significantly reduce prices?
Yes, biosimilars typically reduce branded biologic prices by 30-50%, contingent on market acceptance and payer policies.
References
- NIH Hypogonadism Statistics, 2022
- FDA Drug Approvals Database, 2018-2023
- IQVIA National Sales Perspective, 2022
- CMS Reimbursement Policies, 2023
- Industry Reports on Biosimilar Entry and Testosterone Market, 2023
Note: All data and projections are estimates based on current market trends and publicly available information. Continuous market developments may alter these forecasts.
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