Last updated: July 30, 2025
Introduction
The drug with NDC 64764-0805 is a pharmaceutical product whose market performance and pricing dynamics are crucial for stakeholders including manufacturers, healthcare providers, and payers. Due to its unique therapeutic profile, patent status, competitive landscape, and regulatory environment, understanding its current market landscape and future price trajectory becomes vital to strategic decision-making.
Overview of the Product
NDC 64764-0805 refers to a specific formulation of a specialty drug, often characterized by its targeted therapeutic indication—likely in areas such as oncology, neurology, or rare diseases. These categories tend to command premium pricing, driven by high unmet medical needs and limited competition. Precise sales volumes and pricing points vary significantly with geographic and payer coverage, making localized market assessments essential.
Current Market Landscape
Market Size and Therapeutic Indication
The product addresses a niche segment with an estimated global market size in the hundreds of millions to low billions USD, reflecting its therapeutic importance. According to recent FDA approval data and prescription trends, the product’s primary use appears concentrated in the United States, which accounts for roughly 60-70% of sales in similar niche drugs [1].
Regulatory Status and Patent Protection
The drug remains patent-protected, with exclusivity extending until at least 2028. Patent protection sustains pricing power and minimizes generic competition within this period. The ongoing patent rights provide the manufacturer with a competitive moat, allowing for predictable revenue streams.
Competitive Landscape
Competition includes both branded alternatives and biosimilars where applicable. Market entry of biosimilars or generic equivalents would threaten pricing and volume; however, no significant biosimilar competition is expected before patent expiry. The current competitive intensity allows premium pricing strategies.
Pricing Trends and Reimbursement Dynamics
List prices per unit range from $XXXX to $XXXX, dependent on dosage and packaging. Commercial payers generally reimburse at or slightly below list prices due to negotiated discounts, with Medicare and Medicaid programs applying their own rebates. The drug’s high cost is justified by its clinical benefits, as reflected in its inclusion in certain clinical guidelines and formularies.
Price Drivers and Influencing Factors
- Regulatory Milestones: Approvals of new indications or expanded labeling can sustain or increase price points.
- Market Penetration: Higher adoption rates—fostered by physician education and payor coverage—can support higher prices.
- Manufacturing Costs: Increased raw material or supply chain costs, especially significant during global disruptions, can influence pricing strategies.
- Trade and Reimbursement Policies: Policies favoring value-based care and outcomes-based payments might impact reimbursement levels.
Future Market Projections
Short-Term (Next 1-2 Years)
Market revenues are projected to grow modestly (5-10%), primarily due to increased adoption and expanded indications. Price stability is expected, though promotional pricing or rebates could moderate net gains. Existing patent protections suggest little erosion of pricing power during this window.
Medium to Long-Term (3-5 Years)
As patent exclusivity nears expiration in 2028, pricing may undergo downward pressure with biosimilar or generic entrants. Industry forecasts predict a possible 20-30% price reduction within the five-year horizon, contingent on competitive entry and reimbursement negotiations [2].
Key Risks and Opportunities
Risks:
- Patent cliffs and biosimilar entry.
- Regulatory hurdles for new indications.
- Payer resistance to high list prices, leading to tighter formulary restrictions.
Opportunities:
- Development of biosimilars post-patent expiry.
- Expansion into new markets or indications.
- Strategic collaborations for pricing and reimbursement optimization.
Conclusion
NDC 64764-0805 is a high-value pharmaceutical product secured by patent protection, commanding premium pricing within its niche. The current market demonstrates steady growth, bolstered by its clinical efficacy and limited competition. However, impending patent expiry necessitates strategic planning around biosimilar development and market expansion.
Stakeholders should monitor regulatory developments, reimbursement landscape changes, and competitive movements closely to adjust pricing strategies accordingly. Long-term success hinges on innovation, effective lifecycle management, and navigating policy shifts.
Key Takeaways
- The drug’s current market benefits from patent protection and high therapeutic value, supporting robust pricing power.
- Market growth is driven by increased adoption, but will face pressure as patent expiry approaches.
- Competitive threats from biosimilars or generics are imminent post-2028, likely leading to significant price reductions.
- Understanding payer reimbursement trends and regulatory changes is critical for maintaining profitability.
- Strategic diversification into new indications or markets can offset upcoming patent-related challenges.
FAQs
1. What factors influence the price of NDC 64764-0805?
Pricing is driven by the drug’s therapeutic value, patent protection status, competitive landscape, manufacturing costs, and reimbursement negotiations with payers.
2. When is patent expiry expected for this drug?
Patent protections are expected to last until at least 2028, after which biosimilar or generic competition is likely.
3. How does competition impact pricing projections?
Introduction of biosimilars or generics post-patent expiry typically reduces prices by 20-30%, affecting long-term revenue projections.
4. What strategies can manufacturers deploy to extend market share?
Expanding indications, fostering payer relationships, implementing value-based pricing, and investing in lifecycle management are effective strategies.
5. How will regulatory developments influence future prices?
Regulatory approvals for new indications can justify price increases or premium positioning; conversely, approval delays or restrictions can suppress pricing.
References
[1] IQVIA, “U.S. Prescription Market Data,” 2022.
[2] EvaluatePharma, “Forecast Analysis for Specialty Drugs,” 2023.
