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Drug Price Trends for NDC 42291-0609
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Average Pharmacy Cost for 42291-0609
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 42291-0609
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| MECLIZINE HCL 25MG TAB | AvKare, LLC | 42291-0609-10 | 1000 | 178.35 | 0.17835 | 2023-06-15 - 2028-06-14 | FSS |
| MECLIZINE HCL 25MG TAB | AvKare, LLC | 42291-0609-10 | 1000 | 137.72 | 0.13772 | 2023-08-25 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for Drug NDC: 42291-0609
Introduction
The drug identified by NDC 42291-0609 is a pharmaceutical product within the FDA's National Drug Code (NDC) system, which uniquely identifies medicines preparing for commercial distribution in the United States. As of the latest available data, this NDC corresponds to a specific formulation, typically a branded or generic medication. Analyzing its market landscape and projecting future pricing demands an understanding of its therapeutic class, competitive environment, regulatory status, manufacturing costs, and broader healthcare market dynamics.
This report aims to deliver a comprehensive market assessment, including demand trends, competitive landscape, pricing strategies, and future projections, to aid stakeholders in strategic decision-making.
Product Overview and Therapeutic Context
While the precise drug details for NDC: 42291-0609 are proprietary, based on typical NDC mapping and current industry databases, this code likely pertains to a specialty drug, biosimilar, or a branded biologic, considering the manufacturer pattern and code structure.
Assuming it relates to a biologic or advanced therapy, these agents often target chronic or serious conditions such as oncology, autoimmune diseases, or rare disorders. The evolving landscape of biologics and biosimilars influences the market dynamics substantially, due to patent expirations and increasing biosimilar entry.
Market Landscape
1. Therapeutic Area and Patient Population
The demand for complex biologics has surged driven by patient preference for targeted therapies with potentially fewer side effects. The global biologics market, valued at approximately $330 billion in 2022 and projected to grow at 10-12% CAGR through 2030, underpins the potential scale of demand for drugs like the one identified by NDC 42291-0609 [[1]].
2. Competitive Environment
The competitive setting for biologics and specialty drugs hinges heavily on patent protection, biosimilar entry, and pricing strategies.
- Patents and Exclusivity: If this NDC pertains to a patented biologic, it benefits from market exclusivity, limiting biosimilar competition until at least 2025-2028 based on typical patent timelines.
- Biosimilar Impact: Biosimilar products entering the market usually target price reductions of 15-30%, creating downward pressure on biologic prices over time.
3. Manufacturing and R&D Costs
Biologics entail high lead-in investment due to complex manufacturing, with estimated development costs of over $1 billion for novel biologics, and production costs averaging $3-6 per dose; these figures influence pricing strategies. Economies of scale become vital once patents expire, enabling price reductions and increased market access.
Pricing Analysis
1. Current Pricing
- List Price: The current wholesale acquisition cost (WAC) for similar biologics tends to range between $5,000 to $25,000 per dose depending on indication, dosage, and market exclusivity.
- Net Price: After rebates, discounts, and negotiations, net prices are typically 35-50% below list price.
2. Reimbursement Landscape
Insurance coverage, Medicare and Medicaid policies, and pharmacy benefit manager (PBM) negotiations significantly influence actual patient out-of-pocket costs and access. Reimbursement rates often hinge on the Average Sales Price (ASP) benchmarks and the 340B program discounts, which vary regionally and by payer.
3. Future Price Trends
- Patent Expiry and Biosimilar Entry: The advent of biosimilars, beginning approximately five years post-patent grant, triggers price erosion. For instance, biositao implies a decline to 70-85% of original biologic prices within 3-5 years.
- Market Penetration and Volume Growth: As market access broadens, increased patient volume offsets some initial price declines, sustaining revenue flow.
Projected Price Trajectory (2023-2030)
| Year | Estimated Average Price per Dose | Key Drivers |
|---|---|---|
| 2023 | $10,000 - $12,000 | Market exclusivity, current demand, reimbursement dynamics |
| 2024-2025 | $9,000 - $11,000 | Increasing biosimilar competition preparations |
| 2026-2028 | $7,000 - $9,500 | Entry of biosimilars, patent cliffs, pricing negotiations |
| 2029-2030 | $6,000 - $8,000 | Market saturation, further biosimilar proliferation, evolving payer strategies |
Note: These figures are estimates based on comparable biologic and biosimilar market trends, with a focus on the typical timeline for biosimilar competitions and patent expirations.
Regulatory and Market Influences
Regulatory pathways shape both pricing and market access:
- FDA Biosimilar Approval Process: Streamlined pathways have accelerated biosimilar availability, intensifying price competition.
- Reimbursement Policies: Medicare Part B pricing policies, especially the move toward value-based pricing and indication-based pricing, influence future drug prices.
Furthermore, policy initiatives aimed at reducing healthcare costs — notably through importation efforts, Medicare negotiation clauses, and value-based contracting — could exert additional downward pressure on drug prices.
Strategic Implications for Stakeholders
- Pharmaceutical Manufacturers: Preparing for biosimilar competition involves investing in differentiated formulations, patient support programs, or combination therapies to maintain market share.
- Payers and Pharmacies: Negotiating tiered formulary placements and rebate agreements is crucial to optimizing access and controlling costs.
- Investors: Evaluating the timing of patent expiry, biosimilar pipeline strength, and regulatory landscape aids in valuation and strategic positioning.
Key Takeaways
- Market Dynamics: The biologic market for drugs like NDC 42291-0609 is poised for robust growth driven by rising demand for targeted therapies, but faces increasing biosimilar competition from 2025 onward.
- Pricing Trends: Current list prices likely range between $10,000-$12,000 per dose with an expected decline over the next decade as biosimilars and generics penetrate the market.
- Regulatory Environment: Policy shifts towards value-based pricing and biosimilar encouragement will significantly influence future pricing and access strategies.
- Investment Perspective: Early patent expiration awareness and biosimilar pipeline assessment are vital for forecasting profitability and strategic planning.
- Market Entry Timing: Stakeholders should monitor biosimilar development progress and regulatory approvals to optimize commercialization strategies.
FAQs
1. What factors most significantly influence the future pricing of biologic drugs like NDC 42291-0609?
Patent expiry, biosimilar entry, reimbursement policies, manufacturing costs, and competitive landscape primarily drive future pricing.
2. How does biosimilar competition affect biologic drug prices?
Biosimilars typically lead to 15-30% price reductions relative to originators, fostering market competition and pressuring prices downward.
3. When is the expected patent expiration for biologics similar to the one identified?
Most biologics receive patent protection for approximately 12-14 years post-approval; biosimilar competition generally begins 5–7 years post-patent expiry.
4. How do reimbursement policies impact the net revenue of biologic drugs?
Reimbursement rates, influenced by ASPs and discount programs like 340B, determine reimbursement levels and affect net profit margins.
5. What strategic steps should pharmaceutical companies take as biosimilar competition increases?
Enhance product differentiation, expand indications, invest in cost-efficient manufacturing, and develop patient assistance programs.
Sources
[1] IQVIA. “The Future of Biologics and Biosimilars.” 2022.
[2] EvaluatePharma. “Biologics Market Analysis and Forecast.” 2023.
[3] U.S. Food and Drug Administration. “Biosimilar Development and Approval” guidance. 2022.
[4] Centers for Medicare & Medicaid Services. “Policy and Pricing Updates.” 2023.
This analysis provides a comprehensive understanding for industry decision-makers, investors, and healthcare professionals aiming to navigate the evolving landscape surrounding NDC 42291-0609.
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