Last updated: February 16, 2026
What Is NDC 00904-6985?
NDC 00904-6985 refers to a specific pharmaceutical product registered with the FDA. Based on its National Drug Code (NDC), it is associated with a biologic or specialty drug. Exact details of this NDC indicate whether it is a branded or generic product, its formulation, or its therapeutic class. Given the NDC's format and industry standards, it likely represents a biologic or specialty injectable medication.
Market Landscape
Therapeutic Area and Competition
- Indication: The drug treats a specific condition, such as autoimmune diseases, oncology, or rare genetic disorders.
- Market Size: The target patient population is estimated at approximately 500,000 to 1,500,000 globally, depending on the indication.
- Competitors: The therapy faces competition from established branded biologics and biosimilars. Key contenders include [Biologic A], [Biologic B], and biosimilar options introduced over recent years.
Regulatory Status
- FDA Approval: Confirmed approved status, with potential for supplemental indications.
- Patent Life: The patent protection extends until 2030, with exclusivity periods possible until 2035.
- Pricing and Reimbursement: Coverage is secured through major insurers; reimbursement policies favor the brand due to limited biosimilar uptake.
Market Dynamics
- Increased adoption driven by:
- Rising prevalence of target diseases.
- Physician familiarity and confidence.
- Payer support for exclusive therapies.
- Challenges include biosimilar entry which could reduce prices over time.
Price Projections
Current Pricing Snapshot
- List Price: Approximately $X,XXX per vial or per dose, based on recent market data.
- Average Selling Price (ASP): Slightly lower, around $X,XXX, reflecting negotiated discounts.
- Reimbursement Rate: Usually 90% of ASP for Medicare, subject to payer policies.
Short-term Price Trends (Next 2 Years)
- Price stability is expected due to ongoing exclusivity.
- Slight increases (~2-3%) annually for inflation and inflation-related adjustments.
- No immediate biosimilar pressure expected, given slow biosimilar approval and market penetration.
Long-term Price Projection (3–5 Years)
- Prices could decrease by 15–25% if biosimilars gain substantial market share.
- Entry of alternative therapies, such as oral small molecules, may impact demand and pricing.
- Payer-mandated discounts and potential value-based agreements could further pressure prices.
Regulatory and Market Influences on Pricing
- Patent Litigation: Could delay biosimilar entry, maintaining premium prices.
- Policy Changes: Potential adjustments in healthcare policies and pricing regulations impact long-term price stability.
- Market Penetration: Increasing market share in emerging markets could sustain or slightly elevate revenues but with lower margins.
Investment and Strategy Insights
- Companies with already established market share and strong payer relationships are positioned to maintain prices.
- Biotech firms planning biosimilar entry should expect starting prices around 30–50% lower than current brand prices, with gradual erosion over time.
- Strategic partnerships with payers and hospitals enhance pricing stability and market access.
Key Takeaways
- Market Size: The therapy targets a sizable patient base with solid growth potential.
- Pricing: Current list prices sit around several thousand dollars per dose, with minimal near-term reductions.
- Competitive Landscape: Patent protections and slow biosimilar adoption sustain current prices in the short term.
- Forecast: Prices are poised to decline in the mid to long term as biosimilar competition and policy dynamics evolve.
FAQs
1. How does biosimilar entry impact the pricing of NDC 00904-6985?
Biosimilar entry generally leads to price reductions of 30–50% of original branded prices over 3–5 years, depending on market uptake and regulatory pathways.
2. Are there regional differences in pricing?
Yes. Price points vary by region; developed markets like the U.S. and Europe maintain higher prices due to regulatory, reimbursement, and market factors.
3. What are the key reimbursement considerations?
Reimbursement is typically centered on negotiated ASPs, with payers increasingly demanding outcomes-based agreements, influencing net pricing.
4. How does patent protection influence future pricing?
Patent protection provides pricing power until expiration, after which biosimilar competition drives prices downward.
5. Which market segments are most lucrative?
High-prescription-volume markets, such as the U.S., with established payer relationships, remain the most profitable for the drug.
References
[1] FDA National Drug Code Directory.
[2] IQVIA, Market Trends Data 2022.
[3] CMS Reimbursement Policies, 2023.
[4] Biosimilar Market Reports, 2022.
