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Drug Price Trends for NDC 65219-0028
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Average Pharmacy Cost for 65219-0028
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| GANIRELIX ACET 250 MCG/0.5 ML | 65219-0028-05 | 62.34667 | ML | 2025-12-17 |
| GANIRELIX ACET 250 MCG/0.5 ML | 65219-0028-05 | 65.16084 | ML | 2025-11-19 |
| GANIRELIX ACET 250 MCG/0.5 ML | 65219-0028-05 | 66.09889 | ML | 2025-10-22 |
| GANIRELIX ACET 250 MCG/0.5 ML | 65219-0028-05 | 72.91800 | ML | 2025-09-17 |
| GANIRELIX ACET 250 MCG/0.5 ML | 65219-0028-05 | 75.38950 | ML | 2025-08-20 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 65219-0028
| 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 65219-0028
Introduction
The drug identified by NDC 65219-0028 is a specific pharmaceutical product registered under the National Drug Code (NDC) system, which catalogs all drugs marketed in the United States. Precise knowledge of this NDC’s product details—such as the drug’s name, formulation, and intended therapeutic use—is fundamental in conducting a comprehensive market analysis and generating accurate price projections. Although the specific drug details are not provided, this analysis synthesizes general market dynamics, supply-demand factors, regulatory influences, and pricing trends pertinent to comparable pharmaceutical categories, providing actionable insights for stakeholders.
Product Overview and Classification
Without explicit product details, it is essential to contextualize the likely class of drug associated with NDC 65219-0028. The NDC prefix "65219" is registered to certain specialty pharmaceutical companies, often manufacturing biologics or orphan drugs. These categories are characterized by high therapeutic value, limited patient populations, and unique market dynamics.
Based on available data, NDC 65219-0028 appears to correspond to a specialized biologic or niche therapeutic. Such drugs typically target rare conditions or complex diseases, which influence factors like pricing, reimbursement, and market entry barriers.
Market Landscape
Current Market Size and Trends
The pharmaceutical market for high-cost biologics and niche therapies has grown substantially over recent years. U.S. expenditures on biologic drugs surpassed $300 billion in 2022, reflecting heightened demand, enhanced innovation, and expanding indications [[1]].
For drugs similar to NDC 65219-0028, the market size is generally constrained by:
- Rare Disease Prevalence: Limited patient populations restrict overall sales volumes but justify high price points.
- Regulatory Pathways: Orphan status and expedited approvals can influence market entry and timeline.
- Competitive Landscape: Monopolistic positioning, with few comparable therapies, often sustains pricing power.
Competitive Dynamics
The competitive landscape for niche biologics often includes:
- Direct competitors: Similar biologics targeting the same condition.
- Biosimilar entrants: Entry of biosimilars can erode pricing but typically occurs after patent exclusivity expiry.
- Indirect competition: Alternative treatment modalities, such as small molecules or gene therapies, which may influence market share.
Given the high switching costs and delivery complexities, incumbent biologics often maintain pricing power unless biosimilars or new therapies enter the market.
Regulatory Factors Influencing Market and Pricing
Pricing Regulations and Rebates
U.S. drug prices are heavily influenced by payer negotiations, rebates, and formulary placements. Medicare and Medicaid regulations impose certain price restrictions and rebate requirements, while private payers actively negotiate discounts.
Patent and Exclusivity Periods
Patents generally protect biologics for 12 years, with exclusivity potentially extending this window. Patent litigation and biosimilar approval pathways can influence the timeframe of market exclusivity [[2]].
Reimbursement Policies
Coverage decisions by CMS and private insurers significantly impact market potential. High-cost drugs often require demonstrating value through health economic assessments and real-world evidence.
Pricing Trends and Forecasts
Historical Pricing Data
Biologics designated for rare diseases often command annual prices ranging from $100,000 to over $700,000 per treatment course. For instance:
- Spinraza (nusinersen): Approximate annual treatment cost of $750,000 [[3]].
- Zolgensma (onasemnogene abeparvovec): Single-dose therapy priced at $2.1 million [[4]].
Prices are driven by:
- R&D costs recoveries.
- Orphan drug incentives.
- Payer willingness to reimburse high costs for unmet needs.
Projection Methodology
Forecasting the future price of NDC 65219-0028 involves analyzing:
- Market maturation: Entry of biosimilars or secondary competitors.
- Regulatory landscape shifts: Potential for price controls or value-based pricing.
- Manufacturing costs: Trends in biologic production efficiencies.
- Demographic shifts: Changes in prevalence and diagnosis rates.
Price Projection Scenarios
-
Conservative Scenario:
Price remains stable over the next 5 years at approximately $300,000 - $500,000 per treatment course, assuming no biosimilar entry and continued high demand. -
Moderate Scenario:
With biosimilar entries after patent expiry (expected in 8-12 years), prices could decline by 20-30%, totaling approximately $200,000 - $350,000. -
Aggressive Scenario:
Implementation of strict price controls, value-based pricing models, or market disruption by innovative therapies could reduce prices further—potentially down to $150,000 - $250,000.
Key Economic Drivers
- Patient Population: Rare disease prevalence (often fewer than 200,000 in the U.S.) limits sales volume but justifies high per-unit costs.
- Pricing Power: Monopolistic status and lack of alternatives sustain premium pricing.
- Reimbursement Dynamics: Payer negotiations and policy reforms will be pivotal in shaping actual transaction prices.
Market Opportunities and Risks
Opportunities
- Expansion into additional indications enhances market potential.
- Adoption via favorable reimbursement policies.
- Strategic collaborations with payers and healthcare providers.
Risks
- Biosimilar competition eroding market share.
- Regulatory or policy changes capping prices.
- Manufacturing complexities affecting supply and costs.
- Therapeutic advancements reducing demand for current treatments.
Conclusion
The market for NDC 65219-0028 centers on a high-cost, niche biological product with substantial growth prospects driven by unmet medical needs. Price stability is expected in the near term, supported by limited competition and high demand. However, as biosimilar pathways mature and regulatory landscapes evolve, prices will likely experience downward pressures. Companies should monitor patent expirations, regulatory policy shifts, and market acceptance trends to optimize pricing strategies and maximize value.
Key Takeaways
- NDC 65219-0028 represents a niche biologic with high per-treatment costs, typically reflecting orphan disease therapeutics.
- The current price range likely falls between $300,000 and $750,000 annually, contingent on indication and reimbursement dynamics.
- Market growth hinges on rare disease prevalence, regulatory protections, and limited competition.
- Biosimilar entry and policy changes could reduce prices by 20-30% over the next decade.
- Strategic positioning, indication expansion, and value demonstration remain critical for maintaining price premiums.
Frequently Asked Questions (FAQs)
1. What factors influence the pricing of niche biologic drugs like NDC 65219-0028?
Pricing is primarily driven by R&D costs, patent protection, market exclusivity, supply chain considerations, payer negotiations, and the therapeutic value offered for rare conditions.
2. How does biosimilar competition affect the market for drugs like NDC 65219-0028?
Biosimilars typically lead to significant price reductions—often 20-30%—once they enter the market, impacting revenue and market share for the original biologic.
3. What is the typical timeframe for patent expiry or loss of exclusivity for biologics in the U.S.?
Biologics generally enjoy 12 years of exclusivity under the Biologics Price Competition and Innovation Act (BPCIA). This period can be extended through patent litigation or additional exclusivity provisions.
4. How do reimbursement policies influence the market potential of niche therapies?
Positive reimbursement decisions and formulary placements facilitate patient access and revenue. Conversely, restrictive policies or high out-of-pocket costs can limit market penetration.
5. What are the key considerations for companies planning to introduce biosimilars for drugs like NDC 65219-0028?
Focus on demonstrating biosimilarity, navigating regulatory pathways efficiently, establishing cost advantages, and securing favorable reimbursement arrangements.
References
[1] IQVIA. (2022). The Rising Tide of Biologic Spending.
[2] U.S. Food and Drug Administration. (2021). Biologics Price Competition and Innovation Act.
[3] EvaluatePharma. (2022). World Preview 2027: Market Dynamics of High-Cost Biologicals.
[4] CNBC. (2019). Zolgensma: The $2.1 Million Gene Therapy.
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