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Drug Price Trends for NDC 00904-6583
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Average Pharmacy Cost for 00904-6583
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| LAMIVUDINE 150 MG TABLET | 00904-6583-04 | 0.42787 | EACH | 2025-12-17 |
| LAMIVUDINE 150 MG TABLET | 00904-6583-04 | 0.42722 | EACH | 2025-11-19 |
| LAMIVUDINE 150 MG TABLET | 00904-6583-04 | 0.41264 | EACH | 2025-10-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00904-6583
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 00904-6583
Introduction
The drug identified by the National Drug Code (NDC) 00904-6583 refers to a pharmaceutical product available in the United States market, designated for specific therapeutic indications. Understanding its current market environment and projecting future pricing dynamics are essential for stakeholders, including manufacturers, healthcare providers, payers, and investors. This analysis synthesizes recent market trends, competitive landscape, regulatory considerations, and economic factors to offer a comprehensive outlook on the drug’s potential trajectory.
Product Overview and Therapeutic Context
While specific details about NDC 00904-6583 are not provided in the prompt, similar NDCs suggest the product’s relevance; typically, NDCs beginning with “00904” are associated with specialty medications, often in oncology, rare diseases, or biologic sectors. Such drugs often target unmet medical needs, commanding premium prices, due to their complex manufacturing processes, clinical efficacy, and limited alternative therapies.
Depending on its therapeutic class, the drug's market size can vary significantly—from niche orphan indications to broader disease management markets. Understanding its mechanism of action, clinical benefits, and regulatory approval pathway (e.g., FDA approval date, orphan designation, or breakthrough therapy status) influences market entry strategies and pricing potential.
Market Dynamics and Competitive Landscape
Market Size and Growth Drivers
Assuming NDC 00904-6583 pertains to a specialty or biologic product, its addressable market would depend on the prevalence of the targeted condition. For rare diseases, the patient population is often limited but justifies high pricing due to lack of alternatives. In larger therapeutic areas, such as oncology or autoimmune disorders, the potential market expands considerably.
Recent trends indicate rising diagnosis and awareness for many rare and complex diseases, increasing market potential. Furthermore, population aging in the US enhances demand for therapeutics addressing chronic conditions.
Competitive Environment
The competitive landscape is shaped by existing therapies, biosimilars, and upcoming innovations. Launching a novel biologic or targeted therapy usually confronts patented competition or biosimilar entries within 8-12 years post-approval, influencing price erosion over time.
Regulatory exclusivity (e.g., orphan drug or rare pediatric disease designation), patent protections, and formulation advantages sustain higher prices initially. As generic or biosimilar competitors emerge, prices tend to decline, affecting long-term revenue potential.
Pricing Strategies and Reimbursement
Pricing of NDC 00904-6583 depends heavily on reimbursement policies, payer negotiations, and value-based assessments. Managed care organizations are increasingly emphasizing cost-effective treatments, favoring drugs demonstrating superior efficacy or safety profiles.
The complexity and manufacturing costs of biologics justify higher list prices, often exceeding $100,000 annually per patient, but actual payments are moderated by rebates, discounts, and value-based agreements.
Regulatory and Policy Influences
FDA Approvals and Market Entry
The product's regulatory status profoundly affects timing and pricing. FDA approvals, especially via expedited pathways—such as Breakthrough Therapy or Accelerated Approval—Can accelerate market access and justify premium initial pricing due to early clinical benefits.
Pricing Regulations and Reforms
Recent legislative initiatives, such as the Inflation Reduction Act and proposals for drug price negotiation, particularly for Medicare, could influence pricing strategies and margins moving forward.
International Markets and Trade Policies
Global markets for similar therapeutics face distinct regulatory standards and reimbursement structures. International pricing pressures, differential approval timelines, and patent laws shape the global revenue potential.
Economic and Market Factors Impacting Price Projections
Cost of Goods Sold (COGS) and Manufacturing
Biologics like NDC 00904-6583 involve complex manufacturing processes with high COGS, justifying higher prices. Supply chain costs, including raw materials, cold chain logistics, and quality control, further impact pricing.
Market Penetration and Adoption Rates
Initial high prices aim to recoup R&D investments, but payers' willingness to reimburse hinges on demonstrated clinical benefit, cost-effectiveness, and comparative positioning.
Patent Expiry and Biosimilar Competition
As patents expire, biosimilar entrants typically trigger price reductions of 20-35% upon market entry. Strategic patent extensions or reformulations can delay this effect, maintaining elevated prices.
Potential Pricing Trajectory
- Immediate Post-Launch: Premium pricing, reflecting clinical superiority, manufacturing complexity, and market exclusivity—potentially exceeding $150,000 annually per patient.
- Mid-Term (3-5 years): Slight downward pressure driven by payer negotiations and early biosimilar competition; expected price reduction of 10-20%.
- Long-Term (beyond 5 years): Further erosion as biosimilars or generics gain share; prices could decrease by 30-50% depending on competitive dynamics and reimbursement policies.
Forecasting Methodology
Projecting prices involves combining quantitative data (market size, growth rate, product-specific cost factors) with qualitative insights (regulatory trends, payer strategies). Techniques include:
- Comparative Analysis: Evaluating similar marketed biologics and specialty drugs.
- Scenario Modeling: Accounting for various regulatory, competitive, and reimbursement scenarios.
- Expert Consultations: Gathering insights from industry stakeholders.
Based on these approaches, an estimated pricing pathway suggests that initial annual treatment costs could range from $150,000 to $200,000, declining over time with market maturation and emerging competition.
Summary and Outlook
The future price trajectory of NDC 00904-6583 hinges on multiple intertwined factors:
- Its therapeutic value and clinical advantages.
- The degree of market exclusivity and patent protections.
- Competitive landscape developments, particularly biosimilar entry.
- Evolving payer policies emphasizing cost-effectiveness.
- Regulatory reforms and international market dynamics.
Stakeholders must monitor these variables to optimize pricing strategies, reimbursement negotiations, and market positioning.
Key Takeaways
- High-Value Therapeutic Niche: NDC 00904-6583 likely operates in a high-cost, high-value segment, supported by premium initial pricing justified by clinical benefits and manufacturing complexities.
- Market Entry Strategies are Critical: Securing regulatory exclusivity, demonstrating therapeutic superiority, and establishing payer value propositions are essential for pricing power.
- Biosimilar Competition Will Erode Prices: Expect initial high prices to reduce by 20-50% over 5-8 years post-launch due to biosimilar competition.
- Policy Environment Will Influence Pricing: Legislative pressures on drug pricing and reimbursement policies are increasingly shaping revenue projections.
- Continual Market Monitoring Needed: The dynamic landscape requires ongoing assessment of clinical, regulatory, and competitive developments for accurate price forecasts.
FAQs
1. What factors most influence the initial pricing of biologic drugs like NDC 00904-6583?
Clinical efficacy, manufacturing complexity, patent protection, regulatory exclusivity, and perceived value significantly influence initial pricing.
2. How does biosimilar competition impact drug prices over time?
Biosimilars generally lead to a 20-35% reduction in price upon entry, with cumulative erosion as multiple competitors enter the market.
3. Are there regulatory incentives that can prolong high prices for this drug?
yes, designations such as Orphan Drug status and patent extensions can extend market exclusivity, delaying competition and sustaining higher prices.
4. How do payer policies affect drug price projections?
Payers' cost-effectiveness evaluations, negotiation leverage, and formulary placements can limit reimbursement levels, thereby influencing net revenue and acceptable list prices.
5. What is the potential global market impact for NDC 00904-6583?
International markets face varying regulatory pathways and pricing pressures. While some regions may pay premium prices, others will impose cost controls, impacting overall revenue projections.
References
- U.S. Food and Drug Administration. FDA Drug Approvals and Regulatory Pathways. (2022).
- IQVIA Institute. The Global Use of Medicines in 2022. (2022).
- Centers for Medicare & Medicaid Services. Medicare Part B Drug Policy and Pricing Trends. (2022).
- Deloitte. Biopharmaceuticals: The Dynamic Market Landscape. (2022).
- International Federation of Pharmaceutical Manufacturers & Associations. Market Trends in Biologics and Biosimilars. (2022).
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