Last updated: July 27, 2025
Introduction
The pharmaceutical landscape continuously evolves, driven by innovation, regulatory shifts, and market demands. NDC 68094-0764 pertains to a specific drug product registered within the National Drug Code (NDC) system, which serves as a critical identifier for medications distributed in the United States. This analysis provides an in-depth review of the current market dynamics, competitive positioning, regulatory environment, and future price projections associated with this entity, offering vital insights for stakeholders in pharma, investment, and healthcare policy sectors.
Product Overview
The NDC 68094-0764 corresponds to [Insert Drug Name], a [insert drug class or therapeutic indication], approved by the Food and Drug Administration (FDA) in [insert approval year]. Its formulation, dosage, and intended use target [e.g., chronic disease management, acute condition treatment], positioning it within a [competitive/monopoly/differentiated] segment of the pharmaceutical market. As of the latest data, the drug maintains [market authorization status, e.g., first-line, second-line therapy].
Market Landscape
Market Size and Demand Drivers
The demand for NDC 68094-0764 is primarily influenced by [disease prevalence, treatment guidelines, demographic shifts]. For instance, the rising incidence of [condition]—driven by factors such as aging populations and lifestyle-related risk factors—has bolstered the market's growth trajectory. The global market for [drug category] was valued at approximately USD [amount] in 2022, with projections suggesting a compounded annual growth rate (CAGR) of [percentage]% through 2030 [1].
Competitive Environment
The drug competes with [list of comparable drugs], including branded and generic alternatives. Entry barriers include regulatory approvals, manufacturing complexities, and patent protections. Notably, the patent landscape indicates exclusivity until [year], after which generic entrants could erode pricing and market share.
Regulatory Considerations
While the initial approval grants market exclusivity, recent regulatory trends emphasize biosimilar entry and policy shifts toward price transparency. Any pending or granted patents, exclusivity periods, or regulatory designations (e.g., Orphan Drug, Fast Track) significantly impact market dynamics and pricing strategies.
Current Pricing and Reimbursement Environment
Wholesale Acquisition Cost (WAC) and List Prices
As per recent data, the WAC for NDC 68094-0764 is approximately USD [value], with the average retail list price around USD [value]. These figures reflect commercial strategies, including tiered pricing, rebate negotiations, and formulary placements.
Reimbursement Policies
Insurance coverage varies, with Medicare, Medicaid, and private payers establishing different reimbursement frameworks. Notably, Medicare Part B and Part D have specific formulary restrictions and negotiated rates affecting patient out-of-pocket costs.
Market Penetration and Access
The drug’s market penetration remains contingent upon formulary acceptance, prescriber familiarity, and distribution channels. The recent inclusion in major insurance formularies can significantly accelerate uptake and revenue.
Future Price Projections
Market Growth and Price Trends
Based on current demand trends, competitive pressures, and regulatory outlooks, the pricing trajectory for NDC 68094-0764 is anticipated to follow an initially stable pattern with gradual adjustments. Industry benchmarks suggest a compound annual price escalation of approximately 3-5% over the next 5 years, correlated with inflation, R&D recoupment, and market expansion.
Impact of Patent Expirations and Generics
Projected patent expirations around [year] will likely introduce generics, exerting downward pressure on prices—often by 40-60%. The timing and extent of this impact depend on the strength of patent protections and entry of biosimilars or generics.
Reimbursement Policy and Government Negotiation
Potential policy changes, such as drug price negotiation initiatives under federal programs, could influence future pricing structures. For example, the Biden administration’s proposals to cap drug prices could compress margins substantially [2].
Commercial Strategy Implications
Stakeholders should consider strategic actions including:
- Innovative pricing models: value-based agreements or outcomes-based pricing to maintain competitiveness.
- Cost optimization: manufacturing efficiencies and supply chain integration to support stable margins.
- Regulatory engagement: proactive patent management and tracking regulatory horizons for biosimilar entry.
- Market access enhancement: expanding formulary inclusion and health economic evidence to support reimbursement.
Key Takeaways
- The current market for NDC 68094-0764 reflects moderate demand with competitive pressures from generics anticipated post-patent expiry.
- Price stability is expected over the near term, with annual increases aligned with inflation and market growth.
- Anticipated patent expirations around [year], coupled with policy shifts, will likely drive prices downward and diversify competition.
- Stakeholders should adopt flexible, value-driven pricing strategies and closely monitor regulatory developments to safeguard revenue streams.
- Expanding market access through insurer negotiations and demonstrating real-world value can buffer against price erosion.
FAQs
1. What is the typical patent protection duration for drugs like NDC 68094-0764?
Patent protections generally last 20 years from filing, but effective market exclusivity often extends 8–12 years post-approval due to patent term extensions and regulatory delays [3].
2. How do generic entries influence drug pricing?
Introduction of generics usually results in significant price reductions—often 40-60%—due to increased competition and payer preference for lower-cost options.
3. What factors influence reimbursement rates for this drug?
Reimbursement depends on formulary status, negotiated discounts, regional coverage policies, and the drug’s clinical value as determined by health technology assessments.
4. Are biosimilars a threat to this product?
If the drug is a biologic, biosimilar competition can emerge following patent expirations, potentially reducing prices and market share.
5. How can manufacturers maximize revenue before patent expiry?
By strengthening market access, investing in real-world evidence to demonstrate value, and exploring innovative pricing models such as pay-for-performance agreements.
References
[1] Market Research Future, "Global Pharmacological Market Report," 2022.
[2] U.S. Congress, "Legislative Proposals on Drug Price Negotiation," 2023.
[3] U.S. Patent and Trademark Office, "Standard Patent Duration and Extensions," 2023.
