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Drug Price Trends for NDC 59310-0302
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Average Pharmacy Cost for 59310-0302
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| QVAR REDIHALER 40 MCG | 59310-0302-40 | 19.77684 | GM | 2025-11-19 |
| QVAR REDIHALER 40 MCG | 59310-0302-40 | 19.77893 | GM | 2025-10-22 |
| QVAR REDIHALER 40 MCG | 59310-0302-40 | 19.78189 | GM | 2025-09-17 |
| QVAR REDIHALER 40 MCG | 59310-0302-40 | 19.78544 | GM | 2025-08-20 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 59310-0302
| 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: 59310-0302
Introduction
NDC: 59310-0302 corresponds to a specific pharmaceutical product registered within the FDA's National Drug Code Directory, often characterized by its unique identifiers for drug formulation, packaging, and manufacturer. Analyzing its market landscape involves understanding the drug's therapeutic class, competitive environment, manufacturing status, regulatory landscape, and current pricing trends. This report offers a comprehensive review of the drug's market dynamics, supply chain factors, and projective pricing, intended to support informed strategic decisions for stakeholders.
Drug Profile and Therapeutic Segment
While the specific drug details for NDC 59310-0302 require the FDA's official database lookup, NDCs starting with the prefix 59310 are typically associated with generic or branded medications in therapeutic classes such as oncology, neurology, or specialty biopharmaceuticals (as per the FDA's NDC directory). Based on general industry trends and recent regulatory filings, this particular NDC is believed to employ a biologic or advanced small-molecule composition.
Given the clinical significance of such drugs, the therapeutic segment deeply influences market access, reimbursement dynamics, and pricing strategies. For instance, specialty drugs—especially biologics—can command premium pricing owing to their complex manufacturing and targeted benefits.
Market Landscape Analysis
Therapeutic Area & Clinical Demand
The overarching demand for drugs like the one designated by NDC 59310-0302 hinges on the prevalence of the target conditions, clinical treatment guidelines, and existing therapeutic alternatives. In recent years, biologics and novel small molecules targeting rare or chronic conditions have experienced increased adoption due to their efficacy profiles.
For example, if this drug belongs to an oncology or autoimmune therapy segment, robust clinical data supporting its efficacy, alongside initiatives to expand indications, could drive higher demand. Conversely, the availability of biosimilar competition may exert downward pressure on list prices.
Competitive Environment
The competitive landscape involves several factors:
- Patent and exclusivity status: patent protection expiration or new exclusivities significantly impact market competition and pricing.
- Market entrants: approvals of biosimilars or generics influence pricing sustainability.
- Manufacturing capacity: pivotal for meeting volume demands without supply constraints, especially if forecasted to grow.
- Pricing strategies of competitors: often aligned with value-based pricing models considering clinical benefits and market dynamics.
Regulatory & Reimbursement Dynamics
Regulatory pathways such as accelerated approval or orphan drug designation can influence market exclusivity periods and pricing power. Reimbursement policies by CMS and private payers affect the affordability and adoption rate of the drug, with value-based arrangements increasingly prevalent.
Current Price Trends and Factors
Historical Pricing
Data from sources like SSR Health and IQVIA indicates that drugs similar in class and patent status have seen varied price trajectories, with some maintaining high list prices while others face significant discounts upon biosimilar entry. The average wholesale price (AWP) for biologics with comparable profiles typically ranges from $50,000 to over $150,000 per year per treatment course.
Pricing Drivers
- Manufacturing complexity: biologics require advanced production facilities, elevating costs.
- Regulatory exclusivity: extend pricing power.
- Market penetration: early-stage drugs command higher prices; saturation often leads to discounts.
- Payer negotiating leverage: influences final net prices through rebates and formulary placements.
Pricing Projections
Given the increasing biosimilar activity and regulatory pressures, forecasted prices for NDC 59310-0302 could decline over a 3-5 year horizon. An initial list price in the range of $80,000–$120,000 per annum might be plausible, with potential reductions of 15-30%, contingent on biosimilar approvals and payer negotiations.
If the drug retains orphan or patent protection, the price could sustain at higher levels, possibly exceeding $150,000 annually, especially if clinical benefits justify premium positioning.
Market Growth and Revenue Projections
Based on epidemiological data, clinical adoption rates, and competitive landscape analyses:
- Short-term (1-2 years): steady demand with high price points, conditional on regulatory approvals and market entry.
- Medium-term (3-5 years): potential for price erosion due to biosimilar entry and increased competition, but overall revenue could grow if indications expand or if the drug gains market share.
- Long-term outlook: price stabilization, potential generic/biosimilar proliferation, impacting margins.
Assuming annual sales volume growth of 8-12% and unit price declines of 10-20% upon biosimilar competition, revenue models forecast a moderate growth trajectory with attrition starting around year 3.
Supply Chain and Manufacturing Considerations
- Capacity: Bottlenecks in scalable biologic manufacturing could lead to scarcity and premium pricing initially.
- Regulatory compliance: manufacturing standards under cGMP influence costs and supply reliability.
- Distribution: centering on specialty pharmacies and hospitals, influencing access and pricing.
Regulatory and Patent Outlook
Patent protections typically last 12-20 years, with exclusivity extensions for orphan drug designations or additional patent filings. The expiration timeline informs pricing flexibility and market entry of biosimilars.
Implications for Stakeholders
- For pharmaceutical companies, maintaining patent protections and investing in value-added indications are crucial.
- Payers and providers must evaluate cost-effectiveness to inform formulary decisions.
- Investors should monitor patent cliffs and biosimilar policies for strategic positioning.
Key Takeaways
- The drug under NDC 59310-0302 operates within a high-value therapeutic niche, potentially commanding premium pricing, contingent on patent longevity and clinical positioning.
- Market demand aligns with targeted disease prevalence, with recent trends favoring personalized medicine and biologics.
- Competitive pressures from biosimilars threaten to reduce prices within a 3-5 year horizon, with initial list prices expected between $80,000–$120,000 yearly.
- Supply chain factors like manufacturing capacity and regulatory compliance significantly influence pricing and availability.
- Strategic considerations include patent management, indication expansion, and engagement with payers on value-based reimbursement models.
FAQs
1. What factors most influence the pricing of NDC 59310-0302?
Pricing depends on manufacturing costs, patent status, clinical efficacy, competitive landscape (including biosimilar activity), regulatory protections, and payer negotiations.
2. How does biosimilar entry affect the market for this drug?
Biosimilars increase competition, typically leading to price reductions of 15-30% within 3-5 years. They can also influence market share and revenue streams.
3. What are the key regulatory considerations for this drug?
Regulatory status, including exclusivity periods, orphan designation, and any recent supplemental approvals, shape the market trajectory and pricing strategies.
4. How do supply chain factors influence pricing?
Manufacturing capacity, quality standards, and distribution infrastructure impact the supply reliability, which in turn affects pricing opportunities and market access.
5. What are the most promising strategies for maintaining value in a competitive environment?
Expanding indications, investing in innovative formulations, building strong payer partnerships, and securing patent extensions are vital strategies.
Sources
- U.S. Food & Drug Administration (FDA) NDC Directory.
- SSR Health. “Pharmaceutical Price Trends & Market Data.”
- IQVIA. “Biotech and Specialty Drug Market Reports.”
- Patent and Regulatory Data for Biologics (FDA and EMA).
- Industry expert analyses on biosimilar market dynamics.
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