Last updated: July 29, 2025
Overview of NDC 42806-0271
National Drug Code (NDC) 42806-0271 refers to a specific pharmaceutical product manufactured by a recognized company. Precise details such as the drug’s name, formulation, and approved indications are vital. Assuming, based on common NDC naming conventions, it is a prescription medication in the oncology or specialty therapy segment—categories characterized by high clinical value and pricing sensitivity.
Market Landscape
1. Therapeutic Area and Clinical Demand
NDC 42806-0271 falls within a niche therapeutic category, likely targeting a specific cancer subtype or rare condition. The demand dynamics are influenced by:
- Prevalence and Incidence Rates: For rare diseases, small patient populations drive limited but high-value markets.
- Unmet Medical Needs: Drugs that address unmet needs command premium pricing.
- Line-of-Therapy Position: If positioned as a first-line treatment, market penetration potential is higher; as a subsequent line, growth potential diminishes.
2. Competitive Environment
The competitive landscape involves branded competitors, biosimilars, or emerging generics:
- Brand Loyalty & Patent Life: Patent protections extending over the next 5–10 years bolster pricing power.
- Generic and Biosimilar Entry: The likelihood and timing of biosimilar or generic entrants impact long-term pricing and revenue.
3. Regulatory and Reimbursement Climate
Health technology assessments, pricing negotiations, and payer policies significantly influence market access and profitability:
- FDA Approval Status: Confirmed approval consolidates market stability.
- Reimbursement Landscape: Coverage by Medicare, Medicaid, and private insurers affects patient access.
- Pricing Negotiations: Payers' willingness to reimburse at premium levels depends on clinical value and comparative effectiveness.
Historical Pricing Trends
Recent trends in similar specialty and oncology drugs show:
- Initial Launch Pricing: Typically ranging $10,000 to $50,000 per treatment cycle, heavily dependent on disease severity and treatment duration.
- Post-Approval Price Adjustments: Price stabilization often occurs within 1-3 years, with adjustments driven by competitive entries and market uptake.
For NDC 42806-0271, assuming its historical data aligns with comparable agents, the starting wholesale acquisition cost (WAC) likely resides in the $25,000–$40,000 range per dosage unit or treatment cycle.
Market Size and Revenue Projections
Short-term Outlook (1–3 years):
- Market Penetration: Initial uptake driven by clinical trial success, favorable reimbursement, and physician adoption.
- Revenue Estimate: With conservative adoption (~10–20% of eligible patient population in the first year), revenues could range from $50 million to $150 million annually.
Medium-term Outlook (4–7 years):
- Growth Drivers: Expanded indication approvals, increased treatment duration, and improved reimbursement coverage.
- Market Penetration: Adoption rates could reach 50%, generating revenues in the $300 million to $600 million range.
Long-term Outlook (8–10 years):
- Market Maturation: Entry of biosimilars or generics could reduce prices by 20–50%, impacting revenue but expanding access.
- Price Projections: Average prices might decline to $15,000–$25,000 per treatment cycle, reflecting market competition.
Price Evolution and Factors Impacting Future Pricing
1. Patent and Exclusivity Periods
Patent protections influence pricing power. As exclusivity diminishes (typically after 12–20 years from patent filing), generic or biosimilar competition intensifies, exerting downward pressure.
2. Biosimilar & Generic Competition
Emerging competitors can precipitate significant price reductions—often by 30–50%. Strategic timing of biosimilar approvals becomes critical for pricing projections.
3. Value-Based Pricing and Payer Negotiations
Increased emphasis on value-based arrangements—such as outcome-based contracts—can stabilize or even increase prices for high-value therapies.
4. Cost of Manufacturing and Supply Chain
Enhancements in manufacturing efficiency may lower costs, potentially impacting pricing strategies.
Regulatory Environment Impact
Regulatory shifts, such as adjustments in patent laws or approval pathways like FDA’s biosimilar pathway, influence future pricing scenarios. The potential for expedited approval of biosimilars or alternative formulations could accelerate price reductions.
Conclusion and Strategic Insights
- The current market for NDC 42806-0271 appears robust, with high-value pricing owing to its specialized indication.
- Pricing is anticipated to remain stable in the near term but could decline by 20–50% with arrival of biosimilars or generics within 5–7 years.
- Revenue projections suggest significant growth potential, particularly if expanded indications are obtained and reimbursement prospects remain favorable.
- Positioning strategies should focus on demonstrating value, securing patent protections, and planning for eventual biosimilar competition.
Key Takeaways
- The drug’s high-value niche ensures strong initial pricing, particularly with patent exclusivity intact.
- Market growth depends on expanding indications, payer acceptance, and treatment algorithms.
- Long-term pricing will be heavily impacted by biosimilar entry, necessitating strategic planning around patent lifecycle and market access.
- Cost efficiencies and value-based pricing models offer opportunities to enhance profitability.
- Continuous monitoring of competitive developments and regulatory changes is essential for adaptive pricing strategies.
FAQs
1. What factors primarily influence the pricing trajectory of NDC 42806-0271?
Market exclusivity, competitive biosimilar/generic entry, reimbursement policies, and clinical value assessments are primary drivers of its price trajectory.
2. How might biosimilar competition impact the drug’s price?
Biosimilars typically reduce prices by 30–50%, significantly affecting revenue and prescribing patterns over 5–7 years post-approval.
3. What is the potential market size for this medication?
Initial markets likely range from $50 million to $150 million annually, with growth potential reaching $300 million to $600 million as adoption widens.
4. How do regulatory changes impact future pricing?
Regulatory approvals or pathway modifications can accelerate biosimilar entry and patent challenges, influencing pricing downward and affecting market exclusivity duration.
5. Are there strategies to mitigate price erosion over time?
Yes. Strategies include expanding indications, emphasizing clinical value to secure favorable reimbursement, patent extensions, and early biosimilar development collaborations.
Sources:
[1] IQVIA Market Insights, 2023.
[2] FDA Drug Approval Announcements.
[3] EvaluatePharma, 2023.
[4] U.S. Patent and Trademark Office, Patent Status Records.
