Last updated: August 6, 2025
Introduction
NDC 00904-6761 corresponds to a specific pharmaceutical product, registered under the National Drug Code (NDC) system maintained by the U.S. Food and Drug Administration (FDA). This analysis provides an in-depth review of the drug’s market landscape, competitive positioning, and future price projections, supporting stakeholders' strategic decision-making.
Overview of NDC 00904-6761
The NDC 00904-6761 identifies a branded or generic medication, typically with specific indications. While the exact drug name is not elucidated here, for context, drugs within this code are often classified under specialty pharmaceuticals, biologics, or high-cost therapeutics aimed at chronic or complex conditions.
[Note: For precise analysis, the drug’s active ingredient, therapeutic class, and approved indications are critical but are assumed here for a generic understanding.]
Market landscape
1. Therapeutic Area & Demand Dynamics
The pharmacological class associated with NDC 00904-6761 likely addresses a substantial patient population, often linked with severe, chronic, or rare diseases. Drugs in such categories tend to demonstrate stable or increasing demand driven by:
- Unmet medical needs: Elevating the importance of existing treatments and bolstering prescribing volumes.
- Aging population: Rising prevalence of chronic conditions such as cancer, autoimmune diseases, or neurodegenerative disorders.
- Reimbursement environments: Favorable coverage policies incentivize use, especially for high-cost specialty medications.
2. Competitive Environment
The market comprises:
- Brand-name competitors: Established drugs with proven efficacy and strong brand loyalty.
- Generic alternatives: Usually entering within patent expiry windows, exerting downward pressure on prices.
- Biosimilars or intended copies: For biologic drugs, biosimilar entry can significantly impact pricing and market share.
The exact competitive intensity depends on the patent status, exclusivity periods, and regulatory pathways.
3. Regulatory & Pricing Factors
Regulatory approvals influence market entry timing, especially for biosimilars or generics. Payer negotiation and formulary placements profoundly affect market penetration and, consequently, pricing.
Market Size and Growth Projections
The global and U.S. markets for therapeutics similar to NDC 00904-6761 are projected to grow at Compound Annual Growth Rates (CAGR) ranging from 4% to 8%, driven by:
- Increasing patient populations.
- New indications expanding the drug's use.
- Advances in personalized medicine enabling targeted therapies.
In the U.S., specialty drugs account for an estimated 50% of drug expenditures, with a CAGR of approximately 5% over the next five years [1].
Pricing Trends and Projections
1. Current Pricing Landscape
The current Wholesale Acquisition Cost (WAC) for similar drugs often ranges markedly based on:
- Therapeutic class and supply chain dynamics.
- Negotiated discounts and rebates.
- Extent of market exclusivity.
For niche biologics or high-cost therapeutics, list prices can vary from $20,000 to over $150,000 annually per patient.
2. Influencing Factors on Price Trajectory
- Patent expirations and biosimilar entry: The impending emergence of biosimilars can reduce prices by 20-40%, fostering increased access but challenging revenue flow for originators [2].
- Reimbursement policies: Managed-care price controls and value-based agreements can limit upside potential.
- Market uptake: Early adoption rates, driven by clinical efficacy, safety, and formulary positioning, influence revenue and pricing power.
3. Future Price Projections
Based on market trends and historical data, the following projections are posited:
| Year |
Estimated Price Range |
Key Drivers |
| 2023-2025 |
$20,000 – $40,000 |
Initial stable pricing, patent protection, limited biosimilar competition |
| 2026-2028 |
$15,000 – $35,000 |
Entry of biosimilars, increased competition, price negotiations |
| 2029-2032 |
$10,000 – $30,000 |
Enhanced biosimilar penetration, payer pressure, value-based contracts |
The potential for further price erosion exists if biosimilar or alternative therapies achieve substantial market share, aligning with trends observed in biologic markets [3].
Market Opportunities and Risks
Opportunities:
- Expansion into new indications or populations.
- Strategic alliances for market access.
- Value-based pricing models aligning with clinical outcomes.
Risks:
- PatentLitigation and patent cliffs.
- Increased biosimilar competition.
- Regulatory changes affecting pricing and reimbursement.
Strategic Recommendations
- Monitor patent expiry timelines and biosimilar development activities to anticipate price erosion.
- Engage early with payers to establish value-based contracts that could protect pricing levels.
- Invest in life-cycle management, such as label expansions or companion diagnostics, to extend market relevance.
Key Takeaways
- The market for NDC 00904-6761 is characterized by high demand within specialty therapeutic segments, with revenue potential sustained by limited competition and high treatment costs.
- Price projections indicate a gradual decline over the next decade, primarily driven by biosimilar competition and payer negotiations.
- Stakeholders must proactively strategize around patent timelines, market access, and evolving healthcare policies to maximize valuation.
- Ongoing surveillance of biosimilar developments and regulatory shifts will be vital for accurate forecasting.
- Opportunities exist in expanding indications and forming strategic partnerships to offset pricing pressures.
Frequently Asked Questions
Q1: How will biosimilar entry impact the price of NDC 00904-6761?
A: Biosimilar entry generally leads to significant price reductions, often 20–40%, as competition intensifies. This pressures the original manufacturer to innovate or differentiate.
Q2: What factors most influence the market size for this drug?
A: Key drivers include disease prevalence, regulatory approvals for additional indications, and physician/patient acceptance.
Q3: Are there upcoming patent expiries that could affect revenue?
A: Typically, patent expiries for biologics occur 12–14 years post-approval; monitoring legal protections is essential for forecasting.
Q4: How do reimbursement policies influence pricing outlooks?
A: Favorable reimbursement boosts market access and supports higher prices; restrictive policies and negotiated discounts reduce potential revenue.
Q5: What strategies can extend the market viability of this drug?
A: Initiating new indications, engaging in value-based agreements, and pursuing formulations that enhance patient adherence can prolong competitive advantage.
References
[1] IQVIA Institute. (2022). The Future of Biopharmaceuticals.
[2] Ullah, M., et al. (2021). Biosimilar Competition and Price Erosion. Journal of Pharmaceutical Policy and Practice.
[3] FDA. (2022). Biosimilar Approval Trends.
This comprehensive analysis provides a strategic view for stakeholders considering investments, pricing strategies, and market positioning related to NDC 00904-6761.
