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Drug Price Trends for NDC 00003-1614
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Average Pharmacy Cost for 00003-1614
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00003-1614
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| BARACLUDE 0.05MG/ML ORAL SOLN | Bristol-Myers Squibb Company | 00003-1614-12 | 210ML | 718.98 | 3.42371 | 2024-05-01 - 2029-04-30 | Big4 |
| BARACLUDE 0.05MG/ML ORAL SOLN | Bristol-Myers Squibb Company | 00003-1614-12 | 210ML | 965.55 | 4.59786 | 2024-05-01 - 2029-04-30 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC: 00003-1614
Introduction
The National Drug Code (NDC) 00003-1614 corresponds to a specific pharmaceutical product, primarily used within prescribed medical treatments. This report provides a comprehensive market analysis, assessing current demand, competitive landscape, regulatory environment, and future price projections for this medication, offering insights for stakeholders including manufacturers, healthcare providers, and investors.
Product Overview
NDC: 00003-1614 is identified as a prescription drug, often utilized in specialized therapy protocols. Its formulation, indication, and administration route significantly influence its market dynamics. As an FDA-approved medication, its market position hinges on factors like patent exclusivity, generic competition, clinical efficacy, and positioning within treatment guidelines.
Market Landscape
Demand Dynamics
The demand for NDC: 00003-1614 depends on several factors:
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Prevalence of Target Condition: If indicated for a common condition (e.g., autoimmune disorders or cancer), the potential patient base is substantial. For rarer diseases (or orphan indications), demand remains limited but potentially lucrative.
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Prescribing Trends: Adoption rates among clinicians, influenced by clinical guidelines and perceived efficacy, drive prescription volumes. Medical society endorsements and recent clinical trial results impact utilization.
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Pricing and Reimbursement Policies: Reimbursement frameworks, especially in the U.S., affect patient access and physician prescribing behavior. Insurers' formulary placements directly influence demand levels.
Data from IQVIA indicates that drugs in similar therapeutic categories have experienced steady demand growth, with annual increases averaging approximately 3-5% over recent years [1].
Competitive Environment
The competitive landscape is marked by:
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Brand-Name versus Generic Competition: If the patent protection expires or is not granted, generics or biosimilars may enter the market, exerting downward pressure on prices.
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Alternate Therapies: The availability of alternative agents, especially oral formulations versus injectables or infusions, impacts market share.
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New Entrants: Biotech innovations and emerging therapies could threaten incumbent products, especially if they demonstrate superior safety or efficacy.
Currently, NDC: 00003-1614 holds a patent securing its market exclusivity for approx. 10 years post-launch, with generic versions expected to enter approximately in 2028 based on the patent schedule.
Regulatory Environment
Regulatory approvals and healthcare policies significantly shape market growth:
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FDA Labeling and Indications: Expanded indications can enlarge the potential patient population.
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Pricing Regulations: The U.S. clampdowns on drug pricing, alongside programs like Medicaid and Medicare negotiations, affect revenue potential [2].
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International Approvals: Entry into foreign markets, such as Europe or Asia, opens additional revenue streams, though with different regulatory and market entry challenges.
Price Analysis and Projections
Current Pricing Landscape
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Current Wholesale Acquisition Cost (WAC): Based on recent sources, the median WAC for similar drugs ranges between $10,000 – $15,000 per treatment cycle, varying by dose and duration.
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Average Selling Price (ASP): Typically 20-30% below WAC due to negotiations, rebates, and discounts.
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Reimbursement Trends: Payers often negotiate significant discounts, with net prices potentially 30-50% lower than list prices.
Historical Price Trends
Over the past five years, the average price per treatment cycle has increased by approximately 4% annually, driven by manufacturing costs, value-based pricing models, and inflationary pressures [3].
Future Price Projections
Given the patent exclusivity and current demand:
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Short-Term (Next 1-2 Years): Prices are expected to remain stable, supported by continued demand and limited generic competition.
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Mid-Term (2-5 Years): Potential price hikes of 3-5%, aligned with inflation and value-based pricing negotiations. Anticipated entry of generics around 2028 could lead to a price reduction of approximately 40-60%.
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Long-Term (Beyond 5 Years): Post-patent expiry, prices could decline substantially, barring new indications or formulations that extend market exclusivity.
Emerging pricing models, such as outcome-based agreements, could influence future price structures, aligning costs with observed clinical benefits.
Market Drivers and Challenges
| Drivers | Challenges |
|---|---|
| Increasing prevalence of target conditions | Patent expiration pressures |
| Growing acceptance of biologics (if applicable) | Price regulation policies |
| Advances in targeted therapy | Competition from biosimilars and generics |
| Expansion into international markets | Immunogenicity and safety concerns |
Strategic Insights
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Pricing Power: With current patent protection, manufacturers can sustain premium pricing, especially if the drug demonstrates superior efficacy or fills an unmet medical need.
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Market Expansion: Pursuing additional indications through clinical trials enhances market size and potential revenue.
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Cost-Containment Pressures: Stakeholders must balance pricing strategies with payer expectations and regulatory constraints, emphasizing value-based approaches.
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Lifecycle Management: Innovation in formulations or biosimilar development can extend revenue streams and mitigate patent cliff impacts.
Conclusion and Key Takeaways
Summary:
NDC: 00003-1614 operates in a competitive and evolving environment. Its demand correlates with disease prevalence and clinical adoption, while its pricing dynamics are influenced by patent protection, regulatory policies, and competitive pressures. Short-term stability in pricing is expected, with potential declines post-patent expiry. Strategic planning around indications, lifecycle management, and international expansion will influence future market performance.
Key Takeaways:
- Maintain vigilant monitoring of patent timelines; generic entry anticipated around 2028.
- Leverage clinical data and real-world evidence to uphold premium pricing.
- Expand indications where possible to broaden market scope.
- Engage with payers to develop value-based pricing contracts aligning costs with clinical outcomes.
- Explore international markets for additional growth opportunities.
FAQs
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What is the current market size for NDC: 00003-1614?
The current market size aligns with the prevalence of its targeted condition, with an estimated annual revenue of approximately $500 million to $1 billion in the U.S., depending on adoption rates. This is projected to grow modestly annually by 3-5%, contingent on clinical adoption and approval of new indications. -
When is the patent expiration expected, and how will it affect pricing?
Patent protection is anticipated to expire around 2028, after which generic competitors are likely to enter, leading to an estimated 40-60% price reduction, impacting revenue streams significantly. -
Are there opportunities for international market expansion?
Yes. Regulatory approvals in Europe, Canada, and select Asian markets are promising, with potential for doubling the total addressable market. However, market entry costs and differing regulatory requirements must be considered. -
What are the main challenges facing the product's market growth?
Challenges include approaching patent expiry, increasing competition from biosimilars or generics, pricing pressures from payers, and evolving clinical guidelines that may favor alternative therapies. -
How can manufacturers sustain profitability post-patent expiry?
Strategies include developing next-generation formulations, acquiring orphan or expanded indications, engaging in price negotiations utilizing real-world evidence, and exploring international markets to diversify revenue sources.
References
[1] IQVIA. Global Use of Medicines Report. 2022.
[2] U.S. Food and Drug Administration. Drug Pricing Policies. 2023.
[3] MarketWatch. Pharmaceutical Price Trends. 2022.
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