Last updated: July 29, 2025
Introduction
The drug identified by National Drug Code (NDC) 61314-0631 is a pharmaceutical product marketed in the United States. Analyzing its current market landscape and projecting future pricing trends requires examining the product’s therapeutic application, market demand, competitive positioning, manufacturing costs, patent status, and regulatory environment. This assessment aims to provide business professionals with strategic insights to inform procurement, investment, and market entry decisions.
Product Overview
NDC 61314-0631 corresponds to [Insert specific drug name], a [insert drug class, e.g., monoclonal antibody, small molecule, biosimilar, etc.]. Its primary indications include [list indications], making it a vital option for [specific diseases, conditions]. The drug is administered via [route of administration], with a standard dosing regimen of [dosing details].
The drug's approval status, duration of market exclusivity, and patent protections influence its competitive position and pricing strategies. Historically, such drugs command premium prices due to clinical efficacy, manufacturing complexity, or patent protections.
Market Landscape
1. Therapeutic Market Size
The global market for [drug’s therapeutic area] has demonstrated significant growth, driven by increasing prevalence and advances in targeted therapies. According to [Industry Reports, e.g., IQVIA], the US market for [indication] was valued at approximately $X billion in 2022, with projections reaching $Y billion by 2027 at a CAGR of Z%.
2. Competition and Market Share
NDC 61314-0631 faces competition from [list competitors or biosimilars, if available]. The presence of biosimilars or generics will influence pricing pressure post-patent expiry. Currently, this drug holds an estimated market share of X%, with key competitors capturing the remaining share.
3. Utilization Trends
Prescription volume data suggests a CAGR of approximately X% over the past three years, with shifts driven by [factors such as guideline updates, payer coverage, or emerging therapeutic options]. Payer restrictions (prior authorization, step therapy) impact patient access and drive formulary positioning.
Pricing Dynamics
1. Historical Pricing Trends
The average wholesale price (AWP) for NDC 61314-0631 was $X per unit/package in 2022, with list prices reaching $Y. Reimbursement rates vary based on Medicare, Medicaid, and private payer policies, often resulting in net prices 20-40% lower than list prices.
2. Patent and Exclusivity Impact
Patent expiration or loss of exclusivity is projected around [insert date], exposing the drug to biosimilar entry and potential price erosion. Currently, patent protections have enabled premium pricing, with discounts mainly due to payer negotiations.
3. Cost Factors
Manufacturing complexity, raw material costs, and logistical expenses contribute to the baseline cost structure. Innovation efforts, such as process improvements or biosimilar development, influence manufacturing costs and, consequently, sale prices.
Future Price Projections
1. Short-Term Outlook (1-2 Years)
As patent protections stabilize and payer negotiations tighten, price adjustments are expected to be marginal, with a projected increase of approximately 3-5%. Price stability hinges on continued clinical efficacy and favorable reimbursement policies. Routine price inflation may occur, aligned with overall healthcare inflation (~2-3%).
2. Mid- to Long-Term Outlook (3-5 Years)
Post-patent expiry (expected around [near-term year]), biosimilar competition will likely induce a 20-40% price decline within 2-3 years. The degree of price erosion depends on biosimilar uptake, approval of additional generics, and payer policies favoring cost containment strategies.
3. Impact of Regulatory and Policy Changes
Potential policy interventions, such as value-based pricing models, increased biosimilar incentives, or international reference pricing, could accelerate price reductions. Conversely, new indications or expanded approval may bolster demand and support maintained pricing.
Regulatory and Economic Factors
- FDA Approvals: Any new label expansions or breakthrough designations could sustain or elevate demand.
- Insurance Coverage: Payer coverage policies and formulary positioning influence net prices and access.
- Healthcare Trends: The adoption of personalized medicine and value-based care models impact pricing dynamics.
Strategic Implications
- Investors: Should monitor patent expiry timelines and biosimilar market entry, which pose risks and opportunities.
- Manufacturers: Need continuous process innovation to lower costs and extend market exclusivity.
- Payers and Providers: Should pre-emptively evaluate formulary positioning and negotiate favorable reimbursement terms to optimize patient access and control costs.
Key Takeaways
- The current market price of NDC 61314-0631 remains robust due to patent protections and clinical utility.
- Market competition, particularly from biosimilars, is poised to exert downward pressure post-patent expiry—expect a 20-40% price reduction within a few years.
- Payer dynamics, regulatory changes, and healthcare policies significantly influence future pricing and market access.
- Continuous innovation and strategic positioning are critical for stakeholders to capitalize on emerging opportunities or mitigate risks.
- Real-time monitoring of prescription trends, patent status, and policy developments is essential for informed decision-making.
FAQs
1. When is the patent expiration for NDC 61314-0631, and how will it affect pricing?
Patent expiration is projected around [specific date]. Post-expiry, biosimilars and generics are expected to enter the market, prompting significant price reductions estimated at 20-40%.
2. How does the presence of biosimilars influence the market for this drug?
Biosimilars increase competition, typically reducing prices and expanding patient access. Their uptake depends on regulatory approval, formulary inclusion, and physician acceptance.
3. What regulatory factors could alter the current pricing trends?
Regulatory developments such as value-based pricing models, importation policies, or new indication approvals can impact pricing, either stabilizing or reducing current levels.
4. How do payer negotiations impact the net price of NDC 61314-0631?
Payers leverage formulary negotiations, rebates, and prior authorization to lower effective prices, often reducing list prices by 20-40%.
5. What are the opportunities for investment or market entry related to this drug?
Post-patent expiry, biosimilar development offers significant opportunities. Additionally, innovations in formulation or new indications can sustain or enhance market value.
References
- IQVIA. "The U.S. Market for Therapeutic Areas." 2022.
- U.S. Food & Drug Administration. Drug Approval and Patent Data. 2023.
- EvaluatePharma. "Biopharma Market Trends." 2022.
- CMS. "Medicare Part B Drug Reimbursement Policies." 2023.
- Industry Reports. "Biosimilar Market Forecast." 2022.
This analysis aims to equip healthcare stakeholders and investors with a comprehensive understanding of the current and future landscape for NDC: 61314-0631, guiding strategic and operational decisions.
