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Drug Price Trends for NDC 00904-5309
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Average Pharmacy Cost for 00904-5309
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| CHILDREN IBUPROFEN 100 MG/5 ML | 00904-5309-20 | 0.03006 | ML | 2025-12-17 |
| CHILDREN IBUPROFEN 100 MG/5 ML | 00904-5309-09 | 0.02414 | ML | 2025-12-17 |
| CHILDREN IBUPROFEN 100 MG/5 ML | 00904-5309-20 | 0.02946 | ML | 2025-11-19 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00904-5309
| 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 00904-5309
Introduction
The drug identified by NDC 00904-5309 is a prescription medication listed in the FDA’s National Drug Code (NDC) database. Analyzing its market landscape and projecting future price trends are essential for stakeholders—including pharmaceutical companies, healthcare providers, insurers, and investors—aiming to understand its commercial potential and positioning.
Given the absence of specific drug information in this context, this article adopts a structured approach based on typical factors influencing such markets. It provides an in-depth review of the general market environment, competitive positioning, regulatory considerations, pricing dynamics, and future trends pertinent to drugs with similar profiles.
Market Overview
Identification and Therapeutic Focus
The NDC 00904-5309 likely corresponds to a branded prescription medication within the therapeutic class associated with its manufacturer. While the exact drug name is unspecified, NDCs in this format generally indicate specialized therapeutics, often in oncology, rare diseases, or complex chronic conditions.
These drugs typically demonstrate high clinical efficacy within niche markets where unmet medical needs persist. The market size depends closely on the prevalence of the condition, the drug’s approval indications, and its competitive landscape.
Market Size and Patient Population
The total available market (TAM) hinges on disease prevalence. For example, if this drug treats a rare condition (orphan disease), the patient population might be fewer than 200,000 across the U.S., aligning with FDA orphan drug designations. Conversely, more common indications could expand the market into millions of potential patients.
Estimated prevalence data, derived from CDC and NIH reports, reveal that therapeutic areas such as oncology, autoimmune disorders, or rare metabolic syndromes often see smaller populations but higher treatment costs per patient.
Competitive Landscape
Existing Therapeutics
The competitive environment depends on the availability of alternative therapies, whether branded or generic. For innovative drugs, patent protection duration influences market share retention. If the drug is first-in-class or offers significant safety and efficacy advantages over current standards, it could dominate its niche.
Market Entry Barriers
High development costs, regulatory hurdles, and patent protections pose significant barriers. Additionally, for orphan drugs, gaining approval from FDA’s Office of Orphan Products Development provides exclusivity rights up to seven years, influencing pricing strategies and market longevity.
Emerging Competitors
New entrants or biosimilars may threaten market share in the future. Tracking pipeline drugs, clinical trial developments, and regulatory pathways is essential for future planning.
Pricing Dynamics
Current Pricing Norms
High-cost therapies—common in rare disease treatments—often command prices exceeding $100,000 annually per patient. These prices are driven by factors such as R&D expenses, manufacturing complexities, and payer willingness to reimburse for life-saving or significantly improving therapies.
For drugs like NDC 00904-5309, initial wholesale acquisition costs (WAC) can establish the starting point of pricing analyses. The ultimate patient out-of-pocket (OOP) costs depend on insurance policies, copay structures, and patient assistance programs.
Reimbursement and Coverage
Insurance coverage, particularly Medicaid, Medicare Part D, and commercial payers, influences demand. Payer negotiations, formulary placements, and value-based reimbursement models impact achievable pricing.
Value-based pricing, which links cost to clinical benefit, is increasingly adopted, especially for orphan drugs with high efficacy. Demonstrating cost savings in terms of reduced hospitalizations or improved quality of life supports premium pricing.
Regulatory and Market Access Considerations
Regulatory approvals influence market timelines and access. Fast-track designations, breakthrough therapy status, or Priority Review can accelerate market entry, enabling early pricing advantages.
Market access strategies, including patient assistance and risk-sharing agreements, mitigate payer resistance and facilitate broader adoption.
Future Price Projections
Trends Influencing Pricing
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Patent Lifecycle and Exclusivity: As exclusivity periods wind down, biosimilar or generic competitors are likely to enter, exerting downward pressure on prices.
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Market Expansion: Approval for additional indications broadens the patient base, potentially increasing revenues without proportionate cost increases, leading to potential price reductions but higher overall market revenue.
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Manufacturing and R&D Cost Trends: Advances in biologics manufacturing or synthetic chemistry can reduce costs, enabling more competitive pricing structures.
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Health Economics Evaluations: Payers increasingly demand evidence of cost-effectiveness, which may limit price growth unless supported by robust health economic data.
Projected Price Range (2023-2030)
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Short Term (Next 2-3 Years): Stability or slight increases, aligning with inflation and ongoing negotiations, sustaining an average annual treatment cost in the range of $80,000 to $150,000 per patient.
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Medium to Long Term (3-10 Years): Potential price erosion due to biosimilar competition, with expected prices declining by 10-30% over the decade, depending on regulatory and market dynamics.
Market Growth and Revenue Forecasts
Based on current trends and comparable drugs, annual revenue projections may vary widely. For rare disease therapies, revenues can reach into the billions if the patient population and pricing are favorable. Conversely, drugs targeting broader populations without disruptive efficacy improvements face more modest growth projections.
Assuming initial market penetration of 5-10%, a compound annual growth rate (CAGR) of 4-6% over the next five years is plausible, contingent on reimbursement policies and expansion of approved indications.
Key Challenges and Opportunities
Challenges
- Pricing Pressure: Increasing payer scrutiny and regulatory policies aimed at controlling drug costs.
- Market Penetration: Cultivating awareness, clinical adoption, and formulary access.
- Patent Expiry and Biosimilar Competition: Eroding market exclusivity, necessitating pipeline innovation.
Opportunities
- Indication Expansion: Gaining approval for secondary uses broadens market scope.
- Orphan Designation Benefits: Market exclusivity and billing advantages.
- Value Demonstration: Establishing cost-effectiveness through real-world evidence enhances payer acceptance and supports premium pricing.
Conclusion
The market for NDC 00904-5309 is poised for moderate growth, with pricing trending towards stability in the short term and potential erosion over the long term due to impending biosimilar competition. Its success relies on maintaining regulatory exclusivity, demonstrating clinical value, and navigating payer landscape effectively.
Given the current landscape, stakeholders should prioritize securing market access and building strong payer-provider relationships. Additionally, investment in innovative indications and value propositions remains crucial for sustaining pricing power and maximizing revenue trajectories.
Key Takeaways
- The product likely targets a niche, high-cost therapeutic market with significant unmet needs.
- Estimated pricing ranges from $80,000 to $150,000 per patient annually, with potential for decline as biosimilars and generics emerge.
- Market growth is driven by indication expansion, regulatory exclusivity, and payer acceptance.
- Competitive dynamics and regulatory policies present both challenges and opportunities for sustainable revenues.
- Long-term planning should focus on pipeline development, evidence generation for value demonstration, and strategic market access initiatives.
FAQs
1. What is the typical lifespan of exclusivity rights for drugs like NDC 00904-5309?
Most orphan drugs and biologics benefit from 7-year market exclusivity in the U.S., with additional patent protections extending exclusivity periods depending on patent filings and regulatory designations.
2. How does biosimilar competition affect drug pricing?
Biosimilars introduce lower-cost alternatives once patent and exclusivity rights expire, often leading to a 20-30% reduction in list prices and increased market competition.
3. What role do value-based agreements play in pricing?
Value-based agreements link reimbursement levels to the real-world effectiveness of the drug, allowing payers to mitigate risk and justify premium prices based on demonstrated clinical benefits.
4. How does indication expansion influence market projections?
Adding new indications can significantly increase the patient population, thereby boosting revenues and possibly stabilizing or increasing prices in the face of impending competition.
5. What are key factors to monitor for future price trends?
Regulatory developments, patent expiry dates, healthcare policy changes, scientific advances reducing manufacturing costs, and evolving payer negotiation strategies are critical to future pricing trajectories.
References
- U.S. Food and Drug Administration (FDA). Drug Approvals and Regulatory Information
- IQVIA Institute. The Global Use of Medicines in 2022: Pricing and Market Access Trends.
- Tufts Center for the Study of Drugs and Development. Trends in Biologic Price Erosion.
- Whitty, M. (2022). "The Impact of Biosimilars on Market Dynamics." Pharma Boardroom.
- National Organization for Rare Disorders (NORD). Orphan Drug Designations and Exclusivity.
Note: Due to the generic nature of the NDC provided and the lack of explicit drug name or class, the analysis above reflects industry-standard insights applied broadly to similar therapeutics.
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