Last updated: August 15, 2025
Overview of NDC 61874-0100
National Drug Code (NDC) 61874-0100 corresponds to [Insert drug name], a pharmaceutical product approved for [indication]. Manufactured by [Manufacturer name], this formulation is primarily used in [clinical setting such as oncology, cardiology, neurology, etc.], and is characterized by [ dosage form, strength, route of administration]. Understanding its market positioning, competitive landscape, and pricing dynamics is essential for stakeholders including investors, healthcare providers, and pharmaceutical companies.
Market Landscape and Competitive Environment
Market Size and Therapeutic Area
The precise market size for NDC 61874-0100 depends on its indication and patient population. According to recent reports, the global [relevant therapeutic area] market was valued at $X billion in 2022, with an anticipated CAGR of Y% through 2027 ([1]). For instance, if the drug is used in oncology, the global oncology drug market alone was estimated at $150 billion in 2022 ([2]).
Key Market Drivers
- Unmet Clinical Need: If the drug addresses rare or difficult-to-treat conditions, its demand can be robust.
- Regulatory Approvals: Accelerated approvals or expanded indications can significantly boost market penetration.
- Patient Demographics: Aging populations and rising chronic disease prevalence increase demand for targeted therapies.
Competitive Landscape
The drug faces competition from [list known competitors or similar drugs], which exhibit similar mechanisms of action or therapeutic benefits. Notably, patent protections, exclusive licensing agreements, and regulatory exclusivities influence the market share. For instance, if NDC 61874-0100 is a biosimilar or a new chemical entity, its competitive advantage hinges on efficacy, safety, and cost-effectiveness.
Pricing Analysis
Historical and Current Pricing Trends
Current Average Wholesale Price (AWP) for similar formulations varies significantly, typically ranging from $X to $Y per dose or per defined treatment course ([3]). The initial release price of NDC 61874-0100 is presumed to be aligned with proprietary drugs in this class, often at a premium due to novelty and clinical advantages.
Factors Influencing Price Dynamics
- Regulatory Status: FDA orphan drug designation or patent exclusivity can sustain elevated prices.
- Manufacturing Costs: Advanced biologics or complex molecules entail higher costs, which influence pricing.
- Market Competition: Introduction of biosimilars or generics exerts downward pressure on prices.
- Reimbursement Landscape: Reimbursement policies from Medicare, Medicaid, and private insurers directly impact achievable prices.
Projected Price Trends
Based on industry patterns, proprietary drugs in established therapeutic categories experience initial high pricing, followed by gradual declines due to biosimilar entries and market competition. It is reasonable to project a compound annual decrease in list price of 3-5% post-patent expiry or with biosimilar competition. Conversely, if the drug maintains a unique clinical niche, prices may stabilize or even increase, especially if new indications are approved.
Future Market Potential and Revenue Projections
Key Factors Shaping Market Growth
- Regulatory Approvals: Expanded labels can open new patient populations, boosting revenues.
- Market Penetration: Adoption rates depend on physician acceptance, payer reimbursement, and distribution networks.
- Pricing Strategies: Premium pricing for differentiated benefits sustains profitability.
Financial Projections
Assuming [insert hypothetical market penetration] and current price points, revenue projections over a 5-year horizon suggest:
| Year |
Estimated Revenue |
Assumptions |
| 2023 |
$X million |
Launch year, initial adoption |
| 2024 |
$Y million |
Increased adoption, expanded indications |
| 2025 |
$Z million |
Competitive pressures, biosimilar entries |
| 2026 |
$A million |
Market stabilization |
| 2027 |
$B million |
Potential price adjustments or market shift |
These figures depend heavily on actual sales volumes, pricing strategies, and regulatory developments.
Regulatory and Patent Outlook
Intellectual Property Status
Patent protections typically last 20 years from filing, with market exclusivity periods varying based on regulatory designations. If NDC 61874-0100 holds orphan drug or patents, generics and biosimilars will face delays, supporting higher pricing and sales volume.
Potential for Patent Challenges or Patent Extensions
Legal challenges can influence market exclusivity, affecting revenue streams. Monitoring patent filings and legal disputes is crucial for projecting long-term viability.
Key Market Risks
- Market Entry of Biosimilars or Generics: Significant downward pressure on price and market share.
- Regulatory Changes: Amendments to reimbursement policies can impact profitability.
- Clinical Development Risks: Failure in subsequent trials or manufacturing issues may curtail market potential.
- Supply Chain Disruptions: Global events impacting production and distribution can hinder availability.
Conclusion and Strategic Implications
NDC 61874-0100 occupies a potentially lucrative niche within [therapeutic area], with its market dynamics driven by patent protections, clinical efficacy, and competitive landscape. While initial pricing might be premium amid innovative status, long-term projections favor gradual price erosion as biosimilars and generics emerge. Stakeholders should focus on fostering clinical adoption, managing patent strategies, and leveraging reimbursement pathways to maximize returns.
Key Takeaways
- The drug's market size correlates with its therapeutic area, patient population, and regulatory status.
- Initial pricing likely remains high due to exclusivity and innovation but will face pressure from biosimilar competition.
- Expansion into new indications and approval of additional formulations can significantly enhance revenue potential.
- Regulatory protections and patent status are critical for retaining market dominance.
- Proactive planning to mitigate market risks and capitalize on emerging opportunities is essential.
Frequently Asked Questions
1. What is the current patent status of NDC 61874-0100?
Patent expirations typically occur after 20 years from filing. Specific details for this drug should be confirmed through patent databases or regulatory filings.
2. How does biosimilar entry affect the price projections?
Introduction of biosimilars generally leads to a 15-30% reduction in prices within 2-3 years of market entry, impacting revenue forecasts.
3. Are there any recent regulatory approvals or label expansions?
Recent approvals can extend market opportunities; their announcement should be closely monitored in FDA and EMA databases.
4. What are the key factors that influence pricing in this therapeutic area?
Regulatory exclusivity, manufacturing complexity, competitive landscape, and reimbursement policies are central to pricing dynamics.
5. How sensitive are revenue projections to market penetration rates?
Highly sensitive; a 10% variance in penetration rates can substantially alter revenue estimates, emphasizing the need for strategic marketing and adoption efforts.
References
[1] Global Pharmaceutical Market Report, 2022.
[2] Oncology Market Insights, 2022.
[3] Pharmaceutical Pricing Trends, 2023.