Last updated: February 21, 2026
What is NDC 64380-0827?
NDC 64380-0827 refers to a specific pharmaceutical product registered with the FDA, identified by the National Drug Code (NDC). This code corresponds to [product name], formulated as [specific formulation], indicated for [specific indication]. The product's marketing authorization details, manufacturer, and approval date are available from FDA databases.
Market Size and Demand
Current Market Landscape
- The drug primarily competes in the [target therapeutic category], which commanded a global market value of approximately USD X billion in 2022.
- The U.S. market accounts for roughly X% of this segment, valued at USD Y billion.
- Estimated annual prescriptions in the U.S. for this drug category: approximately Z million, with a market share of X%.
Key Factors Driving Demand
- Increasing prevalence of [indication], which has risen at an annual rate of X% over the past five years.
- Off-label uses expanding the potential patient base.
- Reimbursement policies favoring the drug due to improved patient outcomes.
Competition Overview
- Major competitors include [competitor products], with market shares of X%, Y%, and Z%.
- Patent exclusivity for NDC 64380-0827 extends until [date], affecting market entry and pricing.
Pricing Trends and Projections
Current Pricing Data
- Wholesale Acquisition Cost (WAC): USD [price] per unit.
- Average Wholesale Price (AWP": USD [price]).
- Average sales price (ASP): USD [price].
- Price range in various regions: from USD [low] to USD [high].
Factors Influencing Price
- Manufacturing costs, including raw materials and complexity.
- Regulatory environment and patent status.
- Reimbursement levels and negotiations with payers.
- Pricing strategies of competitors.
Future Price Projections (Next 1-5 Years)
| Year |
Estimated Price Range (USD) per unit |
Key Assumptions |
| 2023 |
USD [low]-[high] |
Stable demand, no major patent changes |
| 2024 |
USD [low]-[high] |
Potential biosimilar entry, slight price decrease |
| 2025 |
USD [low]-[high] |
Patent expiry approaches, increased competition |
| 2026 |
USD [low]-[high] |
Market normalization, possible price stabilization |
| 2027 |
USD [low]-[high] |
Entry of generics or biosimilars, significant price reduction |
Price Adjustments Factors
- Patent expiration could reduce price by up to 50% within two years of generic entry.
- Reimbursement reshuffles by payers could influence pricing strategies.
- Manufacturing efficiencies and supply chain developments may lower production costs.
Regulatory and Policy Impact
- FDA approval status and patent protections heavily influence upfront pricing.
- Price regulation policies, such as Medicare price negotiation efforts, could constrain future prices.
- International pricing variations depend on local regulations and market dynamics.
Key Takeaways
- The drug is positioned within a competitive therapeutic space with a sizable existing demand.
- Current prices reflect limited competition and patent protection.
- Price projections indicate potential declines post-patent expiration, with significant impacts expected due to generic and biosimilar entry.
- Demand growth driven by increasing disease prevalence may buffer some pricing pressures.
- Regulatory developments could substantially alter market dynamics and pricing strategies.
FAQs
1. When does the patent for NDC 64380-0827 expire?
The patent is valid until [date], after which generic competitors can enter the market.
2. How does the entry of biosimilars affect pricing?
Biosimilar entry typically reduces prices by 30-50%, depending on market acceptance and manufacturer strategies.
3. What are the main competitors for this drug?
Major competitors include [product names], holding approximately X% of the market share collectively.
4. How do reimbursement policies impact pricing?
Reimbursement negotiability by payers influences the effective price paid; higher reimbursement levels may keep prices stable, while restrictive policies can suppress them.
5. What future regulatory changes could impact the market?
Potential changes include drug price regulation, increased biosimilar approvals, and adjustments to patent laws, affecting competition and pricing.
References:
[1] U.S. Food and Drug Administration. (2023). FDA drug database.
[2] IQVIA. (2022). Medicine Usage and Market Analysis.
[3] Statista. (2022). Global vaccine and drug market revenues.
[4] Congressional Budget Office. (2022). Drug Pricing and Reimbursement Policies.
