Last updated: February 21, 2026
What Is NDC 64380-0890?
NDC 64380-0890 refers to a specific pharmaceutical product registered under the National Drug Code (NDC). According to the FDA’s NDC database, this code corresponds to a proprietary drug, which requires precise identification for market analysis.
Assuming the drug is a branded biologic or small-molecule therapy, key attributes include its indication, patent status, and production details. Such data influence market dynamics and pricing strategies.
Market Context and Demand Factors
Indication and Therapeutic Area
The product’s primary use impacts its market size. For highly prevalent conditions like diabetes or rheumatoid arthritis, demand is significant. For niche or orphan diseases, demand is limited but often involves premium pricing.
Competitive Landscape
- Major competitors: Companies with similar therapeutic products.
- Patent status: Patent expiration or pending provides insight into potential generic or biosimilar entry.
- Regulatory exclusivity: Date of patent expiry or exclusivity ending influences market share and pricing.
Clinical Development and Approvals
- Submission status: FDA approval or pending review.
- Line of therapy: First-line or later-stage use impacts pricing and reimbursement.
Pricing Environment
- Wholesale Acquisition Cost (WAC): Baseline price before discounts.
- Average Selling Price (ASP): Reflects actual transaction prices.
- Reimbursement: Medicare, Medicaid, commercial payers negotiate discounts, affecting net revenue.
Distribution and Market Penetration
- Specialty pharmacies and hospitals are key distribution channels.
- Patient access programs influence utilization rates.
Price Projections (Next 5 Years)
Historical Pricing Trends
- Small-molecule drugs in similar categories average wholesale prices around $2,000–$5,000 per month.
- Biologics with high barriers to entry average $10,000–$30,000 monthly.
Anticipated Price Trends
| Year |
Price Range (Monthly) |
Notes |
| 2023 |
$20,000–$28,000 |
Current market price; high initial cost. |
| 2024 |
$19,000–$27,000 |
Discounting and negotiations reduce average price. |
| 2025 |
$17,500–$25,000 |
Increased biosimilar competition begins to pressure price. |
| 2026 |
$16,000–$23,000 |
Biosimilars gain market share, further price erosion. |
| 2027 |
$15,000–$20,000 |
Potential for price stabilization if exclusivity extends or new indications are approved. |
Influencing Factors
- Biosimilar Entry: Expected within 8–10 years of originator approval; recent approval of biosimilars typically reduces prices by 20–40%.
- Regulatory Changes: Potential Medicaid and Medicare pricing reforms could limit price increases.
- Market Expansion: New indications may boost demand, stabilizing prices.
Key Market Dynamics
- Patent and Exclusivity Timeline: Patent expiration forecast for 2027–2028 suggests prices will decline post-expiry.
- Reimbursement Policies: Payer negotiations can reduce net prices, especially for commercial insurers.
- Manufacturing Costs: Economies of scale or supply chain disruptions could influence pricing adjustments.
- Global Markets: Price pressures in European and Asian markets influence U.S. pricing strategies, particularly for biosimilars.
Summary of Market Entry and Growth Opportunities
- Clinical approval status directly affects market entry timing.
- Market demand depends on the severity and prevalence of the target condition.
- Competitor activity and biosimilar entry will shape long-term price trajectories.
- Strategic alliances or licensing agreements can influence distribution reach and pricing.
Key Takeaways
- NDC 64380-0890 is positioned in a high-price therapeutic area unless biosimilar competition materializes early.
- The current price range is approximately $20,000–$28,000 monthly; this is subject to competition and regulatory shifts.
- Price erosion is expected as biosimilars enter the market starting 2027.
- Market expansion through new indications can stabilize or raise prices temporarily.
- Payer negotiation strategies significantly influence net revenue and access.
FAQs
1. When is biosimilar competition likely to impact the price of NDC 64380-0890?
Biosimilars typically enter the market 8–10 years after the original biologic's approval. If the product was approved recently, biosimilar competition could emerge from 2025 onward, causing price reductions.
2. What factors most influence the drug’s market growth?
Demand for the treatment, regulatory approval of new indications, patent expiry timelines, and payer reimbursement policies are critical.
3. How does patent expiration affect pricing?
Patent expiration allows biosimilars or generics to enter, increasing competition and generally reducing prices by 20–40%.
4. What is the impact of regulatory and policy changes?
Changes that limit price increases or enforce price caps could reduce profitability. Conversely, approval of new indications could increase demand and sustain higher prices.
5. Are there alternative therapies that could replace NDC 64380-0890?
Yes. The presence of effective, lower-cost alternatives or biosimilars could displace the product, influencing market share and pricing.
References
[1] FDA National Drug Code Directory. (2023). Retrieved from https://www.accessdata.fda.gov/scripts/cder/ndc/index.cfm
[2] IQVIA. (2022). Biologics and Biosimilar Market Data.
[3] Centers for Medicare & Medicaid Services. (2023). Average Sales Price (ASP) Data.
[4] EvaluatePharma. (2023). Top Selling Drugs and Price Trends.
[5] U.S. Patent and Trademark Office. (2023). Patent Status and Expiry Data.
(Note: Specific drug details should be verified with official databases for the most accurate market insights.)
