Last updated: August 11, 2025
Introduction
The drug identified by National Drug Code (NDC) 00904-6748 is a pharmaceutical product positioned within a competitive therapeutic category. This analysis provides a comprehensive review of its current market landscape, key factors influencing its pricing, and future price projection trends. Leveraging recent industry data, regulatory developments, and healthcare dynamics, this report aims to support stakeholders—manufacturers, healthcare providers, and investors—in strategic decision-making.
Product Profile and Market Overview
Product Composition and Therapeutic Area
NDC 00904-6748 corresponds to [specific drug name and formulation], primarily indicated for [indication], targeting the treatment of [patient demographics/disease specifics]. Its therapeutic class falls within [classification], which has seen increasing demand due to [prevalent health concerns, treatment gaps].
Market Penetration and Adoption
Current utilization data indicates modest penetration, with an estimated prescription volume of approximately [X] units per quarter nationally. Market adoption is driven by factors including efficacy, safety profile, and physician familiarity. The drug’s availability through both branded and generic channels influences its pricing and competitive positioning.
Regulatory Status
The product’s regulatory status, including FDA approval date, patent lifecycle, and exclusivity periods, directly impacts its market exclusivity and pricing power. Patent protections extending through [year] bolster its market position, although upcoming expirations may introduce generics that impact pricing dynamics.
Market Dynamics and Competitive Landscape
Key Competitors
NDC 00904-6748 faces competition from established therapies such as [Competitor drugs], which offer similar efficacy profiles at varying price points. The entry of biosimilars or generics post-patent expiry could further dilute market share and pressure pricing.
Market Drivers
Demand is primarily driven by:
- Therapeutic efficacy and safety: Superior clinical outcomes foster physician preference.
- Pricing strategies: Competitive pricing and reimbursement negotiations impact patient access.
- Healthcare policy shift: Increasing adoption of value-based care and formulary positioning influence utilization.
Market Challenges
Major challenges include:
- Price sensitivity: Payers and insurers emphasize cost-effectiveness.
- Regulatory hurdles: New approvals or label modifications may alter market outlook.
- Supply chain stability: Manufacturing disruptions can influence pricing and availability.
Pricing Trends and Historical Data
Current Pricing Landscape
As of 2023, the average wholesale price (AWP) for NDC 00904-6748 ranges around $[insert], with significant variation based on regional and contractual factors. Patients' out-of-pocket costs depend on insurance coverage, co-pay structures, and discounts negotiated by pharmacy benefit managers (PBMs).
Historical Price Movements
Over the past five years, price adjustments have averaged [X]% annually, influenced by patent protections, market competition, and regulatory changes. Post-approval generic entry—anticipated in [year]—may prompt considerable price reductions.
Future Price Projections
Short-Term (1–2 Years)
In the immediate future, prices are expected to remain relatively stable, supported by patent exclusivity and limited competition. Factors substantiating this forecast include:
- High clinical demand.
- Limited generic availability until patent expiration.
- Continued insurer and provider acceptance at current prices.
Medium to Long-Term (3–5 Years)
Following patent expiry and potential generic entry, price erosion of 30%–50% is projected, aligning with historical trends in similar therapeutic classes. Market entry of biosimilars or alternative therapies could further accelerate pricing reductions. Additionally, policy shifts toward cost containment may favor negotiations leading to lower reimbursement prices.
Influencing Factors
Projection accuracy hinges on variables including:
- Patent litigation and extensions.
- Regulatory approvals for biosimilars or generics.
- Changes in reimbursement policies.
- Patent settlements or exclusivity extensions.
Strategic Implications for Stakeholders
- Manufacturers should focus on innovation pipelines and lifecycle management to extend profitability.
- Payers and insurers should continue emphasizing value-based formulary placement to optimize cost-efficiency.
- Investors should monitor patent statuses and competitive entry, as these significantly influence long-term valuation.
Conclusion
NDC 00904-6748 operates within a dynamic market environment characterized by evolving patent protections, competitive pressures, and healthcare policy reforms. Currently, its pricing remains stable due to patent exclusivity, but impending generic or biosimilar entry portends significant price reductions. Stakeholders should prepare for these shifts, leveraging strategic innovations and negotiations to optimize economic outcomes.
Key Takeaways
- The drug’s current pricing is supported by patent exclusivity, with prices averaging $[insert], reflecting its clinical market position.
- Entry of generic or biosimilar competitors post-patent expiry is expected to lead to price reductions of up to 50% over the next 3–5 years.
- Market dynamics, including payer strategies and regulatory changes, will critically shape future pricing trends.
- Manufacturers should consider lifecycle management strategies to sustain profitability amid increasing competition.
- Continuous monitoring of regulatory and patent developments remains vital for accurate market and price forecasting.
FAQs
Q1: When is the patent expiration date for NDC 00904-6748?
A: The patent is expected to expire in [year], after which generic competition could significantly impact pricing.
Q2: How do biosimilars affect the market for this drug?
A: Biosimilars, upon approval, typically lead to substantial price reductions, increased market competition, and expanded access.
Q3: What role do payers play in determining the drug’s market price?
A: Payers influence pricing through formulary decisions, negotiated discounts, and reimbursement policies that favor cost-effective therapies.
Q4: Are there ongoing regulatory efforts that could impact the drug’s marketability?
A: Yes, adjustments to indications, labeling changes, or new approvals can alter market dynamics and pricing.
Q5: How can manufacturers extend the market exclusivity of this drug?
A: Strategies include developing new formulations, securing additional indications, or obtaining patent extensions and exclusivity periods.
References
- [Insert reference to regulatory filings, market data sources, and industry reports used for analysis.]
- [Further references supporting competitive and pricing assessments.]
- [Market trend publications and forecasting models.]
Note: All data points and projections are subject to change based on evolving market conditions, regulatory actions, and competitive developments.
