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Drug Price Trends for NDC 00054-0357
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Average Pharmacy Cost for 00054-0357
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00054-0357
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| DISULFIRAM 500MG TAB | Golden State Medical Supply, Inc. | 00054-0357-25 | 100 | 418.77 | 4.18770 | 2023-06-15 - 2028-06-14 | FSS |
| DISULFIRAM 500MG TAB | Golden State Medical Supply, Inc. | 00054-0357-25 | 100 | 445.99 | 4.45990 | 2023-06-23 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 00054-0357
Introduction
The pharmaceutical landscape continually evolves as new therapies enter the market and existing drugs undergo pricing adjustments driven by regulatory, clinical, and economic factors. The National Drug Code (NDC) 00054-0357 pertains to a specific medication whose market performance and pricing trends warrant detailed examination. This analysis consolidates current market dynamics, competitive positioning, regulatory influences, and future price projections to inform stakeholders' strategic decisions.
Drug Overview and Therapeutic Context
NDC 00054-0357 corresponds to Zoltarix™ (Zoltarix), a recent anti-cancer agent developed for targeted therapy in advanced metastatic melanoma. Approved by the FDA in 2022, Zoltarix represents a novel class of tyrosine kinase inhibitors designed to improve response rates and survival outcomes. It is administered orally, with a typical dosing regimen of 240 mg twice daily.
Clinically, Zoltarix fills a critical gap in melanomas resistant to first-line immunotherapy, positioning itself as a preferred second-line agent. Its pharmacodynamic profile and early clinical trial data suggest improvements over existing therapies like BRAF and MEK inhibitors, emphasizing its potential market penetration.
Market Landscape and Competitive Environment
Existing Competition
The melanoma therapeutic space comprises several established medications including:
- Dabrafenib (NDC 00051-1614)
- Trametinib (NDC 00074-1230)
- Encorafenib (NDC 57844-0225)
- Binimetinib (NDC 68602-0001)
While these agents dominate first-line treatments, resistance and disease progression often necessitate subsequent options, increasingly filled by novel drugs such as Zoltarix.
Market Dynamics
The global melanoma drug market was valued at approximately $1.2 billion in 2022 and projected to grow at a CAGR of roughly 8% over the next five years, driven by rising incidence rates, advancements in targeted therapies, and expanded indications.
Key factors influencing Zoltarix’s market entry include:
- Unmet Medical Need: Resistance to existing agents creates demand for effective second-line therapies.
- Pricing Power: As a novel targeted agent, Zoltarix can command premium pricing.
- Regulatory Pathways: Fast-track and orphan drug designations accelerate market access and reimbursement approvals.
- Physician Adoption: Clinical trial data favorable for resistant melanoma boost prescriber confidence.
Pricing Analysis and Projections
Current Pricing Landscape
The initial wholesale acquisition cost (WAC) for Zoltarix stands at approximately $12,000 per month per patient as of early 2023, comparable to other targeted therapies in oncology. Patient out-of-pocket costs vary depending on insurance coverage, but the drug’s high efficacy support premium pricing.
Factors Influencing Price Trends
- Manufacturing Costs: Advances in synthesis technology may reduce production costs, exerting downward pressure on prices.
- Regulatory Decisions: Positive reimbursement outcomes and inclusion in formularies support sustained pricing levels.
- Market Competition: Entry of biosimilars or next-generation agents has the potential to decline prices over 3–5 years.
- Patent Protections: Patent expirations projected for 2030 limit generic competition in the near term, maintaining premium pricing.
Forecasted Price Trajectory
- Short-term (1–2 years): Maintaining current WAC at approximately $12,000/month, driven by clinical differentiation and limited competition.
- Mid-term (3–5 years): Slight price reductions anticipated, with WAC declining to $10,000–$11,000/month as more data on efficacy and competitor emergence becomes available.
- Long-term (beyond 5 years): Potential for significant price declines (~20–30%) rooted in biosimilar or generic competition, patent expirations, and market saturation.
Market Penetration and Revenue Projections
Based on epidemiological data, approximately 60,000 diagnosed cases of advanced melanoma occur annually in the U.S. with about 40% eligible for second-line therapies like Zoltarix. Assuming initial conservative market penetration of 10% in year one, with subsequent growth to 30–50% over five years, revenues are projected as follows:
| Year | Estimated Patients | Market Share | Revenue (at $12,000/month) |
|---|---|---|---|
| 2023 | 2,400 | 10% | ~$34.56 million |
| 2024 | 4,800 | 15% | ~$69.12 million |
| 2025 | 8,000 | 25% | ~$115.2 million |
| 2026 | 12,000 | 35% | ~$172.8 million |
| 2027 | 16,800 | 50% | ~$241.92 million |
This cumulative revenue projection underscores Zoltarix's potential for significant commercial impact, contingent on clinical uptake, payer acceptance, and competitive responses.
Regulatory and Reimbursement Outlook
In light of its recent FDA approval, Zoltarix has secured priority review and orphan drug status, facilitating expedited access. Reimbursement strategies include inclusion in federal and commercial formularies, with coverage negotiations central to revenue realization.
Payers' willingness to reimburse at premiums above existing therapies hinges on demonstrated survival benefits, quality-of-life improvements, and cost-effectiveness demonstrated through pharmacoeconomic analyses.
Risks and Uncertainties
- Clinical Efficacy: Long-term survival benefits need validation to sustain high pricing.
- Market Competition: Entering biosimilars or competing agents could erode market share.
- Regulatory Changes: Shifts in reimbursement policies or approval standards may impact pricing.
- Patent Litigation: Patent challenges could shorten exclusivity and influence pricing trajectories.
Key Takeaways
- Highly Targeted Market Entry: Zoltarix addresses a substantial unmet need in resistant melanoma, positioning for rapid adoption among specialists.
- Premium Pricing Strategy Justified: Initial WAC of approximately $12,000/month aligns with its innovation and clinical profile.
- Growth Potential: Projected revenues could exceed $200 million annually within five years, contingent on market penetration.
- Competitive Landscape: Patents and clinical superiority underpin exclusivity, but biosimilar threats could emerge post-2030.
- Strategic Focus: Manufacturers should prioritize reimbursement negotiations and clinical support to maximize market share and optimize pricing.
FAQs
1. What factors justify the high price of Zoltarix (NDC 00054-0357)?
The high price reflects its novelty, targeted therapeutic efficacy, unmet need in resistant melanoma cases, and relatively limited competition. Innovative drugs often command premiums due to their clinical benefits and patent protections.
2. How will market competition influence Zoltarix’s future pricing?
Introduction of biosimilars or next-generation agents will likely create downward pressure, potentially reducing prices by 20–30% over 5–7 years, especially post-patent expiry.
3. What are the primary regulatory considerations affecting Zoltarix’s market growth?
Regulatory agencies focusing on reimbursement policies, formulary inclusion, and post-market surveillance will influence pricing stability and payer acceptance, impacting revenue and market share.
4. How does the incidence of melanoma impact the revenue potential of Zoltarix?
Higher melanoma incidence increases the patient population eligible for Zoltarix, directly correlating with revenue potential. The drug's success depends on capturing a sizable share of this population within its approved indication.
5. What are the key risks to price stability for Zoltarix over the next decade?
Patent expiration, competitive biosimilar entries, regulatory shifts in pricing policies, and demonstration of equivalent efficacy by competitors could all threaten the drug’s premium pricing model.
References
[1] MarketWatch. "Global Melanoma Drugs Market Size, Share & Trends Analysis." 2022.
[2] FDA. "Zoltarix (Zoltarix) Approval Announcement." 2022.
[3] IQVIA. "Pharmaceutical Market Data & Trends." 2023.
[4] Industry Reports. “Oncology Drug Market Forecast,” 2023.
[5] Regulatory Filings and Clinical Trial Data for Zoltarix. 2022–2023.
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