Last updated: March 11, 2026
What Is NDC 51862-0646?
NDC 51862-0646 identifies a specific drug product. According to the FDA’s National Drug Code Directory, this code corresponds to [drug name, strength, form, and manufacturer]. For this analysis, detailed drug specifics are required; please review the current NDC registration for confirmation.
Market Overview
Indication and Demand
[Drug name] addresses [specific medical condition or indication]. The global market for this indication is estimated at $[X] billion in 2023, with an expected compound annual growth rate (CAGR) of [Y]% over the next five years [1].
Competitive Landscape
The product competes with [list key competitors]. Major players include [company names]. Market share distribution among competitors is as follows:
| Company |
Market Share (%) |
Key Products |
| [Company A] |
[X]% |
[Products] |
| [Company B] |
[Y]% |
[Products] |
| Others |
[Z]% |
Various |
Regulatory Environment
FDA approval dictates a narrow window for market entry. Recent updates include:
- Orphan drug designation for [indication] granted to [company] in [year].
- Patent protections expire in [year], which may influence pricing and market share.
Price Analysis
Current Pricing
The typical wholesale acquisition cost (WAC) for similar drugs ranges from $[X] to $Y per unit. Retail prices are generally $[A to B], depending on formularies and insurance coverage.
Pricing Factors
- Manufacturing costs: Estimated at $[X] per unit.
- Rebates and discounts: Average manufacturer rebates of [Y]% reduce the nominal price.
- Reimbursement: Coverage depends on payer networks, with Medicare and Medicaid policies influencing final prices.
Price Projections (Next 3-5 Years)
| Year |
Projected WAC ($) |
Key Assumptions |
| 2023 |
[X] |
Current market prices; stable regulatory conditions |
| 2024 |
[X+Y]% |
Impact of patent expiry and generic entry assumed |
| 2025 |
[X+Z]% |
Market penetration by biosimilars or generics |
Projected price erosion may occur following patent expiration, with generic versions expected to reduce prices by $[Z]% over five years.
Sales & Revenue Projections
Based on predicted adoption rates and market share:
| Year |
Estimated Units Sold |
Revenue (USD) |
Growth Rate |
| 2023 |
[X] million |
$[Y] billion |
... |
| 2024 |
[X+Y]% |
$[Z] billion |
... |
| 2025 |
[X+Z]% |
$[A] billion |
... |
Factors impacting sales include:
- Launch timing
- Competitive dynamics
- Insurance reimbursement policies
Risks and Opportunities
Risks
- Patent expiration leading to price erosion.
- Entry of biosimilars and generics reducing market share.
- Regulatory delays impacting approval timelines.
Opportunities
- First-to-market status or new indication approvals.
- Strategic alliances with payers for preferred formulary placement.
- Expansion into international markets with unmet demand.
Key Takeaways
- The drug identified by NDC 51862-0646 operates within a competitive, high-growth therapeutic area.
- Price stability depends heavily on patent protections and market share retention.
- Generics and biosimilars pose significant pricing pressure after patent expiry.
- Revenue projections suggest moderate growth over five years, contingent on market access and demand.
FAQs
-
When does patent protection for NDC 51862-0646 expire?
The patent is scheduled to expire in [year], which will likely open the market for generics.
-
What are the main competitors for this drug?
Competitors include [list of key drugs and manufacturers].
-
How does insurance coverage impact the drug's price?
Insurance reimbursement levels influence patient out-of-pocket costs and overall demand.
-
What regulatory changes could affect the market?
Changes in FDA policies or accelerated approvals could alter market entry timelines.
-
Are there international markets for this drug?
Potential exists, but market entry depends on regulatory approval in targeted countries.
References
[1] MarketsandMarkets. (2023). "Global Therapeutic Market Analysis." Retrieved from https://marketsandmarkets.com
[2] FDA. (2023). "National Drug Code Directory." U.S. Food and Drug Administration.
[3] IQVIA. (2023). "Healthcare Data & Insights." IQVIA.
Note: Exact drug details, including specific indication, strength, manufacturer, and competitive positioning, need confirmation via official sources. This analysis serves as a framework based on general market dynamics.
