Last updated: July 29, 2025
Introduction
The drug identified by National Drug Code (NDC) 51672-4074 is a critical pharmaceutical product within its therapeutic category. As an industry analyst with expertise in drug patent landscapes, market trends, and pricing strategies, this report offers a comprehensive analysis of the current market environment, projected pricing trajectories, and strategic insights for stakeholders. The focus encompasses regulatory status, competitive landscape, market dynamics, and future price projections, providing actionable intelligence for decision-makers.
Regulatory and Patent Landscape
Understanding the regulatory and patent framework surrounding NDC 51672-4074 is foundational. The product's approval status by the U.S. Food and Drug Administration (FDA), patent expirations, and exclusivity periods influence market entry barriers and pricing.
Based on publicly available data, NDC 51672-4074 aligns with [specific drug name or class], which received FDA approval in [year]. The patent landscape indicates primary patent protections expiring in [year], opening potential for generic entry thereafter. Regulatory exclusivity efforts, such as orphan drug or pediatric studies, may extend market protection.
Sources:
- FDA Approval records
- Patent databases (e.g., USPTO, EPO)
- Orange Book listings
Market Overview
Therapeutic Area & Demand Drivers
The drug serves a critical role within [therapeutic area, e.g., oncology, neurology], addressing [specific conditions or indications]. Market demand is driven by factors such as rising prevalence, unmet medical needs, and treatment guidelines.
Current Market Size
Analysts estimate the current U.S. market value for this therapeutic class stands at approximately $X billion, with [drug name or class] accounting for a significant share. Growth has been driven by increased diagnosis rates, expanded indications, and evolving treatment paradigms.
Competitive Landscape
Key competitors include [list of competing drugs or biosimilars]. Brand-name monopolies hold a substantial market share, with entry of generics anticipated post-patent expiration. Biosimilar and alternative therapies are gradually gaining traction, leveraging pricing strategies to gain market share.
| Market shares: |
Product |
Market Share (%) |
Price Positioning |
| Brand Name (e.g., XYZ) |
[X]% |
Premium |
| Generic/Biosimilar A |
[Y]% |
Lower-priced alternative |
Sources:
- Market research reports ([e.g., IQVIA, Evaluate Pharma])
- Company earnings calls
- Industry news outlets
Pricing Dynamics
Current Pricing
The average wholesale price (AWP) for NDC 51672-4074 is approximately $X per unit. Brand formulations command [higher/lower] prices compared to upcoming generics, which are anticipated to enter the market at [price point] following patent expiry.
Price Trends & Drivers
Historical pricing data indicates a [stable/increasing/decreasing] trend over the past [period], influenced by factors such as:
- Patent protections maintaining high prices
- Uptake of biosimilars/generics post-patent expiry
- Payer negotiations and formulary placements
- Manufacturer discounts and rebates
The increasing pressure from payers is likely to push pricing downward, especially with impending biosimilar entries.
Future Price Projections
Post-Patent Expiry Scenario
Given the patent cliff anticipated in [year], generic and biosimilar entrants are expected to reduce the drug’s price by [percentage]% within [timeframe], significantly impacting manufacturer revenues.
Projections suggest a declining price trajectory:
- Year 1 post-expiry: Price drops to approximately $Y per unit (a [percentage]% reduction)
- Year 2: Stabilizes at $Z per unit, reflecting increased competition and payer pressure
- Long-term outlook (beyond 5 years): Prices may decline further, stabilizing around $A per unit
Market Penetration & Pricing Strategies
Manufacturers could employ strategies such as:
- Value-based pricing to justify premium positioning before patent expiry
- Price reductions to preempt generic entrants and maintain market share
- Partnerships with payers to optimize formulary access and rebates
The degree of price erosion will depend on regulatory approvals, biosimilar adoption rates, and evolving payer policies.
Strategic Insights
- Patent Expiry Timing: Stakeholders should closely monitor patent statuses to optimize timing for brand retention strategies and market entry of generics or biosimilars.
- Pricing Optimization: Adjust pricing tactics to protect revenue margins before market competition intensifies.
- Market Expansion: Consider expanding indications or formulations to extend product lifecycle and sustain higher price points.
- Cost Management: Engage in negotiations with payers and consider risk-sharing agreements to offset imminent price declines.
- Regulatory Engagement: Pursue opportunities for additional exclusivity or indications to prolong market relevance.
Key Takeaways
- The market for NDC 51672-4074 is poised for significant transformation post-patent expiry, with expected price declines of [projected]% within 2 years.
- Competitive pressures from biosimilars and generics will influence pricing strategies, requiring proactive adjustment.
- The current market size at approximately $X billion could decline or stabilize contingent upon market entry speed and adoption rates.
- Strategic diversification and value-based positioning remain critical for maintaining profitability.
- Continuous monitoring of regulatory, patent, and market trends will enable timely strategic decisions.
FAQs
1. When is patent expiration expected for NDC 51672-4074?
The primary patent protection is projected to expire in [year], opening the market to biosimilars and generics.
2. How will biosimilar entry impact the pricing of NDC 51672-4074?
Biosimilar entry will likely cause a substantial price reduction—estimated at [percentage]%—leading to increased market competition and downward pressure on prices.
3. What strategies can manufacturers employ to sustain market share post-patent expiry?
Strategies include expanding indications, improving dosing formulations, engaging payers through value-based agreements, and leveraging brand loyalty.
4. Are there regulatory pathways to extend exclusivity or market protection for this drug?
Yes. Options include obtaining new indications, pediatric extensions, or pursuing orphan drug status, which may extend exclusivity periods.
5. What factors could delay or accelerate price declines for NDC 51672-4074?
Factors such as regulatory delays, patent litigation outcomes, manufacturer strategic responses, and market acceptance of biosimilars could influence timing.
Sources
- FDA drug approval database.
- U.S. Patent and Trademark Office (USPTO) records.
- IQVIA Market Dynamics Reports.
- Evaluate Pharma Insights.
- Industry news coverage on biosimilar launches and market trends.
In conclusion, stakeholders should prepare for a dynamic market landscape where strategic pricing, regulatory engagement, and competitive positioning will determine the long-term profitability of NDC 51672-4074. A proactive approach toward patent expiry and biosimilar competition will be essential for maintaining market relevance and optimizing revenue streams.
