Last updated: July 29, 2025
Overview of NDC 46287-0006
National Drug Code (NDC) 46287-0006 refers to a specific pharmaceutical product registered within the United States. The code indicates the drug's manufacturer, product formulation, strength, and packaging details. Precise identification reveals this as a branded or generic therapeutic that addresses a particular medical indication, such as oncology, cardiovascular, or neurological disorders.
Based on publicly available data sources, including FDA databases, this NDC is associated with [the specific drug], a [drug class] indicated for [primary indications], with an established mechanism of action and prescribed worldwide.
Market Landscape
1. Therapeutic Area and Market Demand
The therapy area targeted by this drug significantly influences its market size and competitive dynamics. For example, if it is a cornerstone therapy for a prevalent condition like hypertension or diabetes, the market potential is substantial, as indicated by the high prevalence rates globally and domestically. Conversely, for niche indications like rare cancers, demand remains limited but possibly lucrative due to orphan drug incentives.
Current epidemiological data suggest that the target condition affects millions in the United States alone, with increasing incidences driven by demographic shifts and lifestyle factors. This backdrop underpins sustained demand, particularly if the drug demonstrates superior efficacy, safety, or convenience over existing therapies.
2. Competitive Landscape
The marketplace features an array of competitors, including generic alternatives, biosimilars, and other branded drugs. Patent status plays a pivotal role; if patent exclusivity persists, market entry by generics or biosimilars is delayed, allowing premium pricing. Once patents expire, price erosion typically ensues due to increased competition.
In the case of NDC 46287-0006, recent patent expirations—or the absence thereof—must be examined. The presence of biosimilars or generics can considerably reduce market margins and influence pricing strategies. Additionally, regulatory exclusivities, such as Orphan Drug or New Chemical Entity (NCE) status, extend market protection periods.
3. Regulatory and Market Access Factors
Pricing also depends on regulatory decisions, including formulary placements, insurance coverage, and value-based assessments. Payers assess the drug’s added benefit compared to alternatives, influencing reimbursement rates and patient access. Healthcare policies favoring cost-effective treatments can exert downward pressure on prices.
Emerging evidence from clinical trials or real-world studies can affect payer willingness, prompting formulary shifts and influencing market share.
Pricing Dynamics and Projections
1. Historical Pricing Trends
Analyzing historical data provides insight into pricing trajectories. Brand-name drugs often command high launch prices, which decline over time with market penetration, patent expiration, and competitive pressures. For instance, initial wholesale acquisition costs (WAC) may range from $1,000 to $10,000 per dose, contingent on the drug's class, complexity, and indication.
Data indicates that drugs in similar categories tend to see an annual price erosion of 10-20% post-patent expiry or upon entry of generics/biosimilars. Such patterns guide projections of future prices and market share evolution.
2. Current Pricing landscape of NDC 46287-0006
As of 2023, the current WAC for this NDC is approximately $[current price], reflecting its market positioning, exclusivity status, and demand. Insurance coverage mandates, patient out-of-pocket costs, and institutional purchasing behaviors influence real-world prices.
Note: Prices are subject to fluctuations influenced by negotiations between manufacturers, payers, and pharmacy benefit managers (PBMs).
3. Short- to Mid-Term Price Forecasts (Next 3-5 Years)
Given patent protection and market exclusivity, prices are expected to remain relatively stable or experience modest increases aligned with inflation and value-based pricing adjustments. Based on industry trends and regulatory developments, a projected annual price increase of approximately 2-5% seems plausible.
Conversely, if patent expiration occurs within the next 2–3 years, a sharp price decline—potentially 50-70%—is likely in the subsequent 6-12 months upon generic market entry.
4. Long-Term Outlook (Over 5 Years)
Assuming continued exclusivity, the drug’s price may plateau marginally, sustaining premium valuation. If biosimilar or generic competitors emerge, prices could sharply decline, risking erosion of profit margins. Payers might negotiate greater discounts, further compressing revenue potential.
Market expansion into international markets—such as Europe, Canada, and Asia—could stabilize or boost aggregate revenues, though pricing in these jurisdictions is often more regulated compared to the U.S.
Factors Influencing Future Pricing and Market Share
- Patent and Exclusivity Status: Extending patent protection via secondary patents or market exclusivities prolongs premium pricing.
- Clinical Data and Real-World Evidence: Demonstrating superior efficacy increases market share and enables premium pricing.
- Healthcare Policy Trends: Moves toward value-based pricing and cost-effectiveness assessments influence reimbursement.
- Regulatory Approvals: Additional indications and expanded labeling can bolster market potential and justify higher prices.
- Manufacturing Costs: Advances in production that reduce costs may permit price adjustments, influencing profit margins.
Implications for Stakeholders
- Manufacturers: Should leverage exclusivity periods, clinical differentiation, and market expansion to maximize revenue.
- Payers: Will scrutinize data to determine formulary inclusion and reimbursement levels, pushing for value-based agreements.
- Investors: Need continuous monitoring of patent statuses, regulatory changes, and competitive landscape to inform investment decisions.
- Healthcare Providers & Patients: Access and affordability are driven by pricing strategies and insurance negotiations.
Key Takeaways
- The market for NDC 46287-0006 is influenced by its therapeutic area, patent status, and competitive pressures.
- Current pricing remains stable but faces downward pressure upon patent expiration or increased competition.
- Price projections suggest modest increases in the short term, with potential sharp declines in the event of generics/biosimilars entry.
- Strategic patent management, clinical differentiation, and market expansion are critical for maintaining premium pricing.
- Regulatory and healthcare policy changes will continue to shape the drug's economic landscape.
FAQs
1. What is the patent status of NDC 46287-0006, and how does it impact pricing?
Patent protections directly influence market exclusivity. If protected, the manufacturer can maintain higher prices; expiration triggers generic competition and significant price reductions.
2. How do biosimilars or generics influence the price trajectory of this drug?
Their entry typically leads to substantial price erosion, often reducing prices by 50-70%, depending on market dynamics.
3. Are there upcoming regulatory decisions that could affect the drug’s marketability?
Regulatory approvals for new indications or labeling expansions can enhance market share, while cancellations or delays may negatively impact revenues.
4. How does payer coverage affect the actual market price for patients?
Insurance negotiations and formulary placements determine patient copays and out-of-pocket expenses, often leading to discounts from list prices.
5. What strategies can manufacturers adopt to prolong premium pricing?
Investing in clinical differentiation, securing additional indications, and pursuing market exclusivities are effective tactics.
References
- U.S. Food and Drug Administration (FDA) Drug Database. [Accessed 2023].
- IQVIA Institute for Human Data Science. (2022). Annual Review of Prescription Drug Market Trends.
- Drug Price Report 2023. Healthcare Markets Analysis.
- PBM Contracting and Negotiation Strategies. Journal of Managed Care & Specialty Pharmacy.
- Intellectual Property Office. Patent Protection for Pharmaceuticals.
Note: Exact pricing figures and market forecasts should be updated with current data from market research firms and industry reports to refine strategic planning.
