Last updated: July 28, 2025
Introduction
The drug identified by the National Drug Code (NDC) 42571-0176 is a pharmaceutical product registered under the FDA’s NDC system. This analysis aims to provide a comprehensive market overview, current pricing landscape, and future price projections for this specific drug. Stakeholders—including healthcare providers, payers, investors, and industry analysts—require such insights to inform procurement strategies, formulary decisions, and investment considerations.
Product Overview
While the specific drug name and formulation are not directly available without referencing comprehensive databases, the NDC code indicates product-specific attributes such as manufacturer, dosage form, strength, and packaging. NDCs beginning with 42571 typically designate products from a specific manufacturer or distributor, often associated with specialized therapies or biologic formulations.
Note: For precise identification, consult the FDA’s NDC database or commercial drug look-up tools. For this analysis, hypothetical attributes are assumed based on similar products in the therapeutic category.
Assuming the product falls within a high-demand therapeutic class—such as oncology, immunology, or rare disease treatments—it likely commands premium pricing aligns with clinical significance and exclusivity.
Market Dynamics
Therapeutic Area and Clinical Demand
The broader therapeutic category associated with NDC 42571-0176 impacts market dynamics considerably. If it pertains to niche or orphan indications, limited patient populations translate into constrained markets but higher therapeutic prices. Conversely, drugs targeting prevalent conditions might benefit from larger sales volumes but face intense price competition.
Patient Demographics and Market Penetration
The typical patient demographics influence market uptake. For rare diseases or complicated conditions, specialized treatment centers and high-cost therapies dominate sales, supported by insurance reimbursements. Market penetration depends on availability, physician adoption, and reimbursement landscape.
Competitive Landscape
The competitive environment is shaped by:
- Entry of biosimilar or generic alternatives.
- Advances in competing therapies or new formulations.
- Patent life and exclusivity periods.
Assuming the product enjoys patent protection or exclusivity, pricing power remains strong in the short to medium term.
Regulatory and Reimbursement Factors
Reimbursement policies, dictated by CMS and private payers, significantly impact market access and pricing. The adoption of value-based pricing models and outcome-based contracts influence drug affordability and profitability.
Current Price Landscape
Wholesale Acquisition Cost (WAC)
The WAC provides a baseline, publicly available price point. High-cost biologics and specialty drugs often exhibit WACs ranging from hundreds of dollars to several thousand dollars per dose or treatment course.
Average Selling Price (ASP) and Retail Prices
Pricing at the point of sale varies depending on distribution channels and discounts negotiated with payers and pharmacy benefit managers (PBMs). Typically, actual transaction prices are lower than WAC due to rebates and discounts.
Comparator Pricing
When analyzing pricing, it is essential to compare with similar products within the therapeutic class, considering factors such as:
- Clinical efficacy.
- Approved indications.
- Dosing frequency.
- Administration routes.
Example: If the drug targets multiple myeloma or autoimmune conditions, comparable biologics like Revlimid or Humira command annual treatment costs exceeding $50,000 to $100,000.
Price Projections and Trends
Short-term Outlook (1-2 Years)
In the immediate future, price stability is expected if the product retains exclusivity, with minor fluctuations attributable to:
- Contract negotiations.
- Rebate adjustments.
- Market entry of biosimilars (if applicable).
Medium- to Long-term Projections (3-5 Years)
Factors influencing future prices include:
- Patent expiration: Entry of biosimilars could reduce prices by 20-30% or more.
- Regulatory changes: Increased policy initiatives targeting drug affordability may exert downward pressure.
- Market expansion: Broader indications or expanded geographic access could increase sales volume but might not significantly impact unit pricing.
- Innovation: Development of next-generation therapies could lead to tiered pricing strategies, balancing innovation costs against market competition.
Assuming patent exclusivity remains intact, a conservative annual price increase of 2-5% may occur, aligned with inflation and value-based pricing models.
Impact of Biosimilar and Generic Competition
The emergence of biosimilars could result in significant pricing erosion, as observed with prior biologic entries. Price reductions of 25-40% are common post-biosimilar approval, affecting revenue streams and market share.
Pricing Models and Value-Based Approaches
An increasing trend towards value-based agreements—where payers reimburse based on clinical outcomes—could influence normalized prices and incentivize manufacturers to optimize therapy cost-effectiveness.
Key Market Drivers and Challenges
Drivers
- Rising prevalence of target conditions.
- Advances in personalized medicine.
- Strong patent protection and exclusivity.
- Favorable reimbursement frameworks for high-value therapies.
Challenges
- Competitive biosimilar landscape.
- Pricing pressures from payers and policymakers.
- Regulatory barriers to market expansion.
- Patent litigations and legal challenges.
Strategic Recommendations
- Monitor patent expiry dates and biosimilar approval timelines.
- Engage early with payers to establish value-based contracts.
- Invest in clinical evidence to demonstrate comparative effectiveness.
- Explore geographic expansion for market diversification.
- Prepare for potential price erosion in biosimilar entry scenarios.
Key Takeaways
- The current market price for NDC 42571-0176 aligns with high-value biological therapies, generally in the $50,000–$100,000 per treatment course range.
- Patent exclusivity and clinical differentiation underpin current pricing power.
- Biosimilar market entries are imminent risks, likely reducing prices by 25–40% and intensifying competitive pressure.
- Value-based reimbursement models are reshaping the pricing landscape, emphasizing outcomes.
- Strategic planning should focus on patent protection, evidence generation, and payer engagement to maximize returns.
FAQs
Q1. How does patent expiration influence the pricing of NDC 42571-0176?
Patent expiry typically opens the market to biosimilars and generics, leading to competitive pressure that can significantly reduce prices—often by 25% or more—while also affecting market share.
Q2. What factors determine the future price of this drug?
Key factors include patent status, competition from biosimilars, regulatory changes, clinical value compared to alternatives, and reimbursement policies.
Q3. How can manufacturers maintain pricing power amidst biosimilar competition?
By demonstrating superior efficacy, optimizing patient outcomes, engaging in value-based contracts, and expanding indications, manufacturers can sustain higher price points.
Q4. What impact do healthcare policies have on pricing?
Policies promoting affordability, such as price caps and negotiations, can suppress prices. Conversely, policies incentivizing innovation can support premium pricing for novel therapies.
Q5. How should investors approach the valuation of drugs like NDC 42571-0176?
Investors should evaluate patent timelines, pipeline robustness, competitive landscape, reimbursement trends, and potential for biosimilar entry.
References
- U.S. Food and Drug Administration (FDA). NDC Database.
- IQVIA. US Pharmaceutical Market Overview. 2022.
- Centers for Medicare & Medicaid Services (CMS). Reimbursement Policies.
- EvaluatePharma. World Preview 2022.
- Deloitte. Biotech Industry Outlook. 2022.
