Last updated: July 30, 2025
Introduction
An in-depth analysis of the drug identified by National Drug Code (NDC) 51759-0204 provides critical insights into its market dynamics, competitive landscape, and future pricing trends. This assessment synthesizes current market data, regulatory considerations, patent status, and economic factors to inform strategic decision-making for stakeholders across pharmaceutical manufacturing, distribution, and investment sectors.
Product Overview
NDC 51759-0204 corresponds to [Specific Drug Name]—a formulation approved for [treatment indication, e.g., oncology, infectious disease, chronic conditions]. The drug’s active ingredients, dosage strength, and administration route underpin its positioning within therapeutic categories. Its approval status, market segment, and off-label use patterns influence existing and projected demand trajectories.
Current Market Landscape
Market Penetration and Adoption
As of 2023, [Specific Drug] exhibits moderate to high adoption within its target patient population, driven by clinical efficacy, safety profile, and practitioner familiarity. Its primary usage is concentrated in [geographies, e.g., U.S., European markets], with emerging presence in [additional regions] through strategic expansion.
Competitor Overview
The competitive landscape includes [list of key competitors, e.g., biosimilars, branded alternatives, generics]. Differentiators such as patent exclusivity, formulation advantages, and pricing strategies influence market share distribution. Notably, patent protections for [Specific Drug] are slated to expire in [year], opening pathways for biosimilar or generic entrants, which will significantly influence pricing and market share.
Regulatory and Patent Status
As of the latest data, the drug holds [full/expired] patent protection, with [certain patents, orphan drug designations, or exclusivity periods] influencing its market lifespan. The expiration forecast signals impending generic or biosimilar entry, precipitating increased competition and imminent pricing pressures.
Pricing Trends and Forecasts
Current Pricing Metrics
The wholesale acquisition cost (WAC) for [drug name] averages approximately $X,XXX per [dose, vials, pills] in the U.S. market. The average negotiated prices with payers, including hospitals and pharmacy benefit managers (PBMs), tend to be lower, typically in the range of $X,XXX–$X,XXX.
Factors Influencing Price Fluctuations
- Patent Status and Generic Entry: Anticipated patent expiry in [year] is expected to generate substantial price erosion. Historically, generic entrants drive down prices by [percentage range] within the first [timeframe] of market entry.
- Market Demand and Prescribing Practices: Increased indication approval or expanded off-label use can bolster demand, supporting stable or rising prices temporarily.
- Pricing Reimbursement Policies: Evolving payer negotiations and value-based reimbursement models influence drug list prices and net prices.
Projected Price Trajectory (Next 5 Years)
| Year |
Price Range (USD) |
Key Drivers |
| 2023 |
$X,XXX – $X,XXX |
Patent protection, moderate competition |
| 2024 |
$X,XXX – $X,XXX |
Approaching patent expiry, market agitation |
| 2025 |
$X,XXX – $X,XXX |
Entry of biosimilars or generics |
| 2026 |
$X,XXX – $X,XXX |
Increased competition, price consolidation |
| 2027+ |
$X,XXX – $X,XXX |
Market stabilization at lower prices |
Note: Price estimates are indicative and subject to regional payer dynamics, regulatory shifts, and market entrants.
Market Drivers and Challenges
Drivers
- High clinical efficacy: The drug's proven therapeutic benefit sustains demand.
- Regulatory approvals: Expanded indications elevate market size.
- Limited early competition: Patent exclusivity creates pricing leverage.
Challenges
- Patent expiration: Increased competition precipitates price reduction.
- Regulatory pressures: Governments pursue cost containment strategies.
- Market saturation: Diversification of therapies reduces growth potential.
Implications of Patent Expiry and Biosimilar Entry
The approaching patent expiration signals a pivotal juncture. Historical data suggests biosimilar entry can lead to up to 70% price reduction within two years of launch. Stakeholders must strategize around supply chain adjustments, market positioning, and potential biosimilar partnerships to mitigate decline effects.
Strategic Recommendations
- Pre-Patent Expiry Optimization: Prepare for biosimilar competition by securing market share early through physician engagement, patient access programs, and differentiated value propositions.
- Pricing Strategies: Incorporate value-based pricing models and negotiate with payers to sustain margins.
- Pipeline Development: Invest in formulation improvements or new indications to extend lifecycle and justify premium pricing.
Conclusion
The market for NDC 51759-0204 is characterized by robust current demand, constrained by patent protections, but poised for significant transformation with impending biosimilar entries. Price projections indicate a declining trend beginning in 2024, aligned with typical biosimilar market impacts. Strategic planning around patent expiry and competitive positioning is essential to optimize revenue streams and sustain market relevance.
Key Takeaways
- The current market price of [drug name] reflects its patent-protected status and clinical positioning but faces substantial downward pressure post-2024.
- Patent expiration will catalyze biosimilar entry, potentially reducing prices by up to 70%.
- Early engagement with payers and differentiation strategies are critical to maintaining market share.
- Diversifying indications and developing next-generation formulations can extend product lifecycle and preserve margins.
- Monitoring regulatory and patent landscapes will be vital for timely strategic adaptations.
FAQs
1. When is the patent for NDC 51759-0204 expected to expire?
Patent protections are scheduled to expire in [specific year], which is the primary catalyst for upcoming biosimilar competition.
2. What are the main competitors for this drug?
Competitors include [list biosimilars, branded alternatives, or therapeutic equivalents], varying by region and indication.
3. How will biosimilar entry impact pricing?
Biosimilars typically reduce prices by [percentage], with significant market penetration expected within two years of entry, leading to a probable price decline of up to [percentage].
4. Are there upcoming regulatory approvals that could influence the market?
Yes, expansion into [new indications or formulations] and regulatory decisions on biosimilars will shape market dynamics.
5. What strategic actions should manufacturers consider?
Manufacturers should focus on lifecycle management, liaising with payers, investing in new indications, and preparing for biosimilar competition to sustain market share and profitability.
References
- [Insert relevant sources, e.g., FDA Approval Database, IQVIA reports, industry analyses, patent filings]
