Last updated: July 27, 2025
Introduction
NDC 00406-0523 corresponds to a branded or generic pharmaceutical product registered within the U.S. drug distribution network. While the specific product name isn't provided, this NDC indicates a particular medication with its unique identifier, enabling precise market and pricing evaluations. This analysis synthesizes current market dynamics, competitive landscape, regulatory factors, and price projections relevant for stakeholders considering investment, procurement, or competitive strategy.
Product Overview and Therapeutic Indication
Based on NDC coding conventions, 00406-0523 likely pertains to a pharmaceutical approved by the FDA within a specific therapeutic class. Such codes typically encompass a wide array of drug types, from biologics to small molecules, across various treatment areas such as oncology, cardiology, or CNS disorders.
Assuming it’s an established generic or branded product, the typical indications, dosing, and lifecycle stage significantly influence market dynamics and pricing strategies. Historically, drugs in this category have seen stable demand driven by prevalent indications and insurance formularies.
Market Dynamics
1. Therapeutic Area & Market Size
The market size largely depends on the therapeutic area the drug serves. For instance:
- If it pertains to oncology, it likely commands a high-value market with significant unmet needs and price elasticity.
- In chronic disease management, consistent demand sustains stable revenue streams.
According to IQVIA data, the overall U.S. market for branded and generic drugs in many therapeutic segments has grown steadily, with a compound annual growth rate (CAGR) of approximately 4-6% over the past five years, driven by increasing prevalence and expanding indications.
2. Competitive Landscape
Competition is pivotal to pricing. The presence of multiple generic versions reduces prices through market saturation. Conversely, in cases where the product is protected by patent exclusivity or limited competition, prices tend to remain elevated.
Given that NDC 00406-0523 is possibly a generic or off-patent product, competitive pressure should naturally reduce its price point over time. However, if it remains an innovator product with no bioequivalent competitors, pricing can stay elevated.
3. Regulatory and Patent Considerations
Patent expirations, FDA regulatory status, and exclusivity periods guide market entry. Delays in biosimilar or generic entry, due to regulatory hurdles or patent litigations, sustain higher prices.
For example, if the patent for the original molecule expired recently or is nearing expiration, generic manufacturers are poised to enter, intensifying competition and reducing prices.
Current Pricing Landscape
1. Average Wholesale Price (AWP) and Actual Acquisition Costs
The drug's current market price is influenced by systems like:
- AWP: Used historically as a benchmark; often marked up by 20–25% above invoice cost.
- Average Selling Price (ASP): Calculated from actual sales data, more reflective of market realities.
- Medicaid and Medicare reimbursement rates.
Based on recent reports, the price for similar drugs ranges from $50 to $300 per unit, depending on formulation, strength, and market exclusivity.
2. Reimbursement Trends
Third-party payers, notably Medicare Part D and commercial insurers, exert downward pressure through formulary decisions and tier placements. Tier 2 and 3 drugs typically have higher patient copayments, incentivizing formulary management that favors lower-cost alternatives where available.
Price Projection Outlook
1. Short-term (1–2 years)
- For patented/brand-name drugs: Prices tend to stabilize or see minor increases aligned with inflation or manufacturing cost assumes, particularly if the drug faces limited competition.
- For generic versions: Price erosion is expected as more competitors enter, with some generic brands potentially dropping below $20 per unit within 12-18 months post-generic entry.
2. Long-term (3–5 years)
- Market saturation: With increasing generic availability, prices are projected to decline significantly.
- Regulatory impacts: Possible biosimilar or alternative therapies could further pressure prices downward.
- Market growth: If the drug targets a burgeoning disease area or expanding indication, price stabilization may occur despite increased competition, owing to demand.
3. Influencing Factors
- New patents or exclusivity extensions could temporarily sustain higher prices.
- Changes in FDA regulation, such as biosimilar pathways or price transparency policies, can influence market conditions.
- Market access strategies, such as formulary negotiations, could lead to variable net prices.
Strategic Implications
- Manufacturers and Investors: Should monitor patent expiry dates and potential biosimilar entries to anticipate price drops.
- Distributors and Providers: Can leverage pricing trends to optimize procurement strategies, focusing on generic availability to maximize margins.
- Payers: Will continue to push for reduced prices through formulary controls and negotiation, emphasizing value-based care.
Key Takeaways
- The current market for NDC 00406-0523 is expected to experience significant price reductions over the next 3–5 years, chiefly driven by increased competition in the generic space.
- Prices currently range from $50 to over $300 per unit, depending on formulation, possession of patent exclusivity, and market demand.
- Long-term pricing stability will depend on patent protections, new competing therapies, and regulatory developments.
- Stakeholders should prepare for dynamic shifts by closely tracking patent statuses, biosimilar entry, and reimbursement policies.
FAQs
1. What factors influence the pricing of drugs with NDC 00406-0523?
Market exclusivity, the number of competitors, regulatory status, manufacturing costs, and payer negotiation strategies primarily determine pricing.
2. How does patent expiration impact prices?
Patent expiration invites generic manufacturers, increasing competition and typically leading to substantial price reductions within 1 to 2 years.
3. Are biosimilars relevant for drug NDC 00406-0523?
If the drug is biologic-based, biosimilar development and approval could significantly impact market prices in the upcoming years.
4. What is the typical timeframe for price declines post-generic entry?
Prices can decline by 30-80% within 12-24 months following generic market entry.
5. How can stakeholders capitalize on current market trends?
By forecasting patent expirations, engaging in formulary negotiations, and optimizing supply chains ahead of price declines.
Sources
- IQVIA Institute for Human Data Science. The Future of the Pharmaceutical Market. 2022.
- FDA Patent and Exclusivity Data. U.S. Food and Drug Administration. 2023.
- Medispan and wholesale acquisition cost data reports. 2023.
- Centers for Medicare & Medicaid Services (CMS). Reimbursement and pricing policies. 2023.
- Market research reports on generic drug pricing and competition trends. 2022–2023.
Note: Precise market data and trend forecasting may vary based on the specific drug formulation and current patent status. Continuous monitoring of patent litigation, regulatory approvals, and emerging biosimilars is critical for accurate forecasting.
