Last updated: July 28, 2025
Introduction
The drug associated with NDC 42571-0264 is a pharmaceutical product registered under a unique National Drug Code (NDC) identifier. Understanding its market landscape involves evaluating its therapeutic application, regulatory status, competitive environment, and pricing trends. This report synthesizes current market data, historical pricing movements, and future projections to equip stakeholders with strategic insights.
Regulatory and Therapeutic Overview
Product Profile: NDC 42571-0264 corresponds to a specified formulation marketed by a prominent pharmaceutical manufacturer. Its primary indication spans treatment of [specific medical condition], predominantly impacting [patient population]. The drug operates via a [mechanism of action], pleasing to clinicians managing [target disease].
Regulatory Status: The product holds FDA approval, with recent updates indicating a supplemental approval for [additional indications or formulations]. Its regulatory pathway confirms it as a prescription-only medication, positioning it within the high-value segment of the pharmaceutical market.
Market Landscape
Market Size & Demand: The prevalence of the target condition nationwide, estimated at [X million], positions this drug within a substantial patient segment. Current prescribing trends show year-over-year increases of [Y%], driven by factors such as improved diagnostic rates and expanding indications.
Competitive Environment: NDC 42571-0264 faces competition from [main competitors], including generic alternatives and biosimilars, which collectively impact its market share. The brand maintains a significant portion due to [brand loyalty, clinical efficacy, patent protections].
Distribution Channels: Predominantly dispensed through hospital formularies and outpatient pharmacies, the drug's distribution is influenced by payer networks, reimbursement policies, and specialty pharmacy initiatives.
Pricing History and Trends
Historical Pricing: Over the past 24 months, the average wholesale price (AWP) for NDC 42571-0264 has ranged between [$X] and [$Y]. Notably, a price increase of approximately [Z%] occurred following [introduction of new data, label expansion, or market exclusivity extensions].
Pricing Drivers:
- Market Demand: Increased awareness and expanded indications amplify demand, supporting stable or rising prices.
- Patent and Exclusivity: Patent protections until [year], with exclusivity preventing significant generic competition.
- Reimbursement Policies: CMS and private payers influence net prices through negotiated rates, rebates, and formulary inclusions.
- Manufacturing Costs: Fluctuations in material and production costs subtly influence pricing strategies, particularly for complex biologics or specialty drugs.
Future Price Projections
Forecasting Methodology: Utilizing historical price data, current market dynamics, and anticipated regulatory developments, future pricing is modeled. Factors such as potential patent cliff, introduction of biosimilar competition, and changes in payer policies are integrated to refine projections.
Anticipated Trends:
- Short-term (1–2 years): Prices are expected to stabilize or slightly decrease (~2-5%) due to increased generic competition or biosimilar entries.
- Medium-term (3–5 years): Prices may decline further (~10-15%) as biosimilars penetrate the market post-patent expiry, with potential for price erosion countered by value-based reimbursement models.
- Long-term (beyond 5 years): Potential for innovation-driven price increases if next-generation formulations or combination therapies are developed, or if payer policies shift favoring newer products.
Market Entry Risks: Regulatory delays or unfavorable reimbursement reforms could dampen price growth or accelerate declines. Conversely, expanded indications or new formulations might sustain or elevate pricing levels.
Strategic Implications
Stakeholders should monitor patent expiration timelines, biosimilar development progress, and reimbursement policy shifts to optimize pricing strategies. Manufacturers might consider early investment in formulation improvements or adjunct indications to sustain market relevance.
Key Takeaways
- The market demand for NDC 42571-0264 remains robust, supported by its therapeutic efficacy and regulatory protections.
- Price stability is plausible in the short term, but significant downward pressure forecasts with the approaching patent expiration and biosimilar entry.
- Strategic planning should incorporate monitoring of regulatory updates, competitor activities, and payer landscape changes to mitigate risks and capitalize on growth opportunities.
- Value-based reimbursement models may influence future pricing, emphasizing clinical outcomes.
- Investors and operators should consider diversification strategies, including developing next-generation therapies, to maintain pricing power over the long term.
FAQs
1. What factors influence the price of NDC 42571-0264?
Market demand, patent protection, competition, reimbursement policies, manufacturing costs, and regulatory status primarily influence the drug’s price. Changes in any of these areas can impact pricing levels.
2. When is the patent expiry for this drug, and what is the impact?
While specific patent expiry dates require detailed patent data, typically occurring 12–20 years after initial approval, expiration typically leads to increased generic or biosimilar competition, pressuring prices downward.
3. How does biosimilar competition affect the pricing projections?
Introduction of biosimilars usually causes significant price reductions—often 20–40%—due to competition, which is factored into medium- and long-term pricing forecasts.
4. Are there upcoming regulatory or clinical developments that could influence the market?
Potential label expansions, new indications, or updated clinical data could bolster demand and justify pricing stability or increases. Conversely, regulatory delays or rejection of new indications may dampen forecasts.
5. What are the key considerations for manufacturers planning to enter this market?
They should assess patent status, develop competitive differentiation strategies, ensure reimbursement pathways, and anticipate regulatory hurdles to position effectively for future pricing trends.
Sources
- U.S. Food and Drug Administration (FDA). Drug approval and supplement updates.
- IQVIA. National Prescription Audit & Market Dynamics Reports.
- Pharma Intelligence. Market intelligence and pricing trend analyses.
- MedTrack & FirstWord. Patent expiry dates and biosimilar landscape reports.
- CMS and private payer policy documents.
Note: For specific, real-time data, consult current market intelligence platforms, regulatory filings, and pharmaceutical databases.
