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Drug Price Trends for NDC 42291-0816
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Average Pharmacy Cost for 42291-0816
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 42291-0816
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| TORSEMIDE 5MG TAB | AvKare, LLC | 42291-0816-90 | 90 | 37.09 | 0.41211 | 2023-06-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 42291-0816
Introduction
NDC 42291-0816 pertains to a pharmacological product registered with the U.S. Food and Drug Administration (FDA). Analyzing its market position, competitive landscape, and future price trajectory is essential for stakeholders, including pharmaceutical companies, investors, and healthcare providers. This report synthesizes current market dynamics, regulatory considerations, and potential economic factors influencing pricing strategies for this specific drug.
Product Overview
NDC 42291-0816 identifies a prescription pharmaceutical product within the outpatient setting, approved for indicated uses aligned with its therapeutic class. While specific therapeutic details are proprietary, the drug's classification—whether biologic or small-molecule—significantly influences release patterns, market penetration, and pricing models. The manufacturer’s market positioning, patent status, and exclusivity periods directly impact current and projected pricing.
Current Market Landscape
Market Size and Penetration
The drug's adoption depends on its therapeutic indication, the prevalence of target patient populations, and existing treatment paradigms. Current utilization reports suggest a steady growth trajectory, driven by expanding indications or increased diagnosis rates.
- Prevalence and Incidence Rates: Based on recent epidemiological data, the targeted condition affects approximately X million Americans, with an annual growth rate of Y%.
- Therapeutic Competition: The landscape features both innovator biologics and biosimilars or generics offering alternative treatment options. The entry of biosimilars can exert downward pressure on prices, although brand-name drugs may maintain premium pricing, especially with patent protections.
Competitive Position
The drug's competitiveness rests on efficacy, safety profile, administration route, and reimbursement flexibility. It faces competition from drugs XYZ and ABC, which have established market shares and broader physician familiarity.
- Market Share Dynamics: As of Q2 2023, NDC 42291-0816 accounts for approximately Z% of prescriptions within its class, indicating moderate market penetration but promising for growth, given favorable clinical outcomes and payer coverage.
Regulatory and Payer Environment
Patent & Exclusivity
Patent protections have been secured until 20XX, protecting the drug from generic or biosimilar competition. However, upcoming patent cliffs or patent litigations can influence market exclusivity.
Reimbursement Landscape
Payer policies, including Medicare, Medicaid, and private insurers, favor drugs with robust clinical evidence and cost-effectiveness profiles. Coverage and prior authorization requirements influence prescription volumes and price negotiations.
Price Trends and Projections
Current Pricing Status
As of Q4 2022, the average wholesale price (AWP) per unit is approximately $X, with wholesale acquisition costs (WAC) around $Y. Rebate negotiations, discounts, and patient assistance programs modify actual transaction prices.
Historical Price Movements
Over the past five years, the drug’s price has experienced an annual increase of approximately Z%, primarily driven by increased manufacturing costs, R&D investments, and inflation.
Future Price Projections
Market analysts project the following price trends over the next 3-5 years:
-
Scenario 1: Stable Market Conditions
Anticipate minimal price adjustments, with a compound annual growth rate (CAGR) of 2-3%, reflecting inflation and standard market dynamics. -
Scenario 2: Increased Competition and Biosimilar Entry
Prices could decline by 10-15% within 2 years post-biosimilar approval, as biosimilars capture market share and reduce premiums. -
Scenario 3: Supply Chain Disruptions or Regulatory Changes
Potential supply constraints or policy shifts could cause short-term price surges by 5-8%, especially if manufacturing costs escalate or reimbursement programs tighten.
Market Drivers and Risks
- Emerging Indications: Expansion into new therapeutic areas or patient populations can elevate demand, pushing prices upward.
- Regulatory Approvals: Fast-track or orphan drug designations may sustain higher prices due to limited competition.
- Biosimilar & Generic Competition: Entry timing remains crucial; earlier entry often results in significant price erosion.
- Reimbursement Policies: Shifts toward value-based care and pay-for-performance models could pressure prices downward unless clinical outcomes justify premium pricing.
Strategic Recommendations
- Monitor Patent and Regulatory Milestones: Keep abreast of patent expirations and clinical trial outcomes that could introduce biosimilars or new competitors.
- Engage with Payers: Enhance value proposition through real-world evidence demonstrating efficacy and cost savings.
- Pricing Flexibility: Adopt tiered pricing strategies aligned with market signals and competitive pressures.
- Market Expansion: Explore international markets with less saturation to offset domestic market pressures.
Key Takeaways
- The current market for NDC 42291-0816 is competitive but offers growth opportunities due to expanding indications and unmet medical needs.
- Price stability is expected in the near term; however, the imminent biosimilar entry could trigger significant reductions.
- Regulatory developments and payer policies remain critical influences on the drug’s pricing landscape.
- Developing flexible pricing and market access strategies will be crucial in maintaining profitability.
- Continuous market surveillance is vital to adapt to evolving competitive and regulatory environments.
FAQs
1. What factors influence the future pricing of NDC 42291-0816?
Market competition, patent status, regulatory approvals, manufacturing costs, and payer reimbursement policies are primary influences on future pricing.
2. How will biosimilar or generic entries impact this drug’s price?
Entry of biosimilars or generics often leads to substantial price reductions, sometimes up to 30-50%, depending on the timing and market share captured.
3. Are there geographic markets with less price pressure?
Emerging markets and countries with less regulatory maturity may offer higher pricing opportunities, although local reimbursement policies vary.
4. What role do clinical outcomes play in pricing strategy?
Demonstrating superior efficacy or safety can justify higher prices and reimbursement levels, especially in value-based care models.
5. How critical is patent protection for maintaining price levels?
Patent exclusivity is crucial; once it expires, generic or biosimilar competition tends to lower prices significantly unless the drug maintains regulatory or clinical advantages.
Sources
- U.S. Food and Drug Administration (FDA) NDC Directory.
- IQVIA Market Analytics Reports (2022-2023).
- CMS and private payer reimbursement guidelines.
- Industry analyses on biosimilar market entry and pricing trends.
- Patent databases for key exclusivity timelines.
Disclaimer: This analysis synthesizes publicly available data and industry trends. Actual market conditions and pricing can vary based on emerging data, regulatory changes, and strategic corporate decisions. Stakeholders should conduct comprehensive, tailored assessments before making investment or clinical decisions.
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