Last updated: August 10, 2025
Introduction
The drug identified by NDC 55513-0924 pertains to a specific pharmaceutical product within the healthcare market, with its pricing and market dynamics influenced by factors such as patent status, market competition, regulatory environment, and unmet medical needs. This analysis provides a comprehensive review of the current market landscape, historical pricing trends, competitive positioning, and future price projections to aid industry stakeholders.
Product Overview
NDC 55513-0924 is associated with [Product Name], a [drug class] indicated for [specific medical conditions]. It is marketed by [Manufacturer Name] and approved by the FDA as of [approval date]. The drug's therapeutic profile positions it as [first-in-class, biosimilar, or generic], with primary competitors including [Key Competitors].
Current Market Landscape
Market Size and Demand
The global and U.S. markets for [drug’s therapeutic area] demonstrate steady growth, driven by increasing prevalence of [related diseases or conditions]. The U.S. market specifically reports [approximate prevalence statistics], fueling demand. The segment's value was estimated at $[value] billion in [year], with an expected CAGR of [percentage]% over the next [years], according to [industry reports or market research firms, e.g., IQVIA, EvaluatePharma].
Market Penetration and Adoption
NDC 55513-0924 has secured [market share]% within its therapeutic segment since its launch in [year], due to factors such as formulary inclusion, pricing strategies, and clinical efficacy. Its uptake is augmented by [therapy guidelines, provider familiarity, insurance coverage].
Regulatory and Reimbursement Factors
The drug benefits from [specific regulatory designations such as orphan drug, breakthrough therapy, etc.], facilitating market access. Reimbursement policies, especially in Medicare and private insurers, significantly influence its adoption. The presence of reimbursement pathways, copay assistance programs, and formulary position impact its market share and revenue.
Pricing History and Trends
Initial Launch Price
At launch, NDC 55513-0924 was listed at approximately $[initial price] per [dosage form], positioning it [premium, competitive, budget-friendly] relative to existing therapies. Price competitiveness was initially driven by [factors like patent exclusivity, lack of generic alternatives].
Price Evolution
Over the subsequent [time period], the average wholesale price (AWP) increased to $[current price], representing a [percentage]% escalation, influenced by factors including:
- Inflation in R&D and manufacturing costs
- Market exclusivity periods
- Reimbursement adjustments
- Formulary negotiations
The entry of biosimilars or generics (if applicable) has introduced downward pressure, with [generic/biosimilar] versions priced approximately [percentage]% lower than the originator, leading to industry-wide price erosion.
Price Benchmarks and Comparators
Compared to alternatives such as [competitors or generic options], NDC 55513-0924 commands a [premium/discount], aligning with its [clinical efficacy, safety profile, or convenience factors].
Market Dynamics and Competitive Landscape
Key Competitors
Major competitors include [Name 1], [Name 2], and [Name 3], each offering [similar or alternative therapies]. The entry of biosimilars/biosimilar candidates [Name 4, Name 5], is expected to influence pricing strategies and market share.
Patent and Exclusivity Timeline
Patent protections for NDC 55513-0924 extend until [year], with data exclusivity arrangements potentially delaying biosimilar entry until [year]. These protections contribute to maintaining premium prices within the forecast period.
Regulatory Developments
Pending regulatory decisions, such as [approval of biosimilars, new indications], could alter market dynamics significantly, influencing pricing and market share.
Price Projection Analysis
Methodology
Forecasting prices involves analyzing historical trends, patent expiry timelines, competitor entry, healthcare reimbursement policies, and anticipated demand. A [quantitative models] approach, such as time series analysis adjusted for market factors, was employed to project [price levels] through [year].
Forecast Summary
| Year |
Estimated Price per Unit |
Key Drivers/Assumptions |
| 2023 |
$[current price] |
Stable patent protection; no biosimilar entry yet |
| 2024 |
$[projected price] |
Pending biosimilar approval impacts pricing |
| 2025 |
$[projected price] |
Increased biosimilar market penetration |
| 2026 |
$[projected price] |
Patent expiry; intensified generic competition |
| 2027+ |
$[decreased price] |
Widespread biosimilar adoption decreases prices |
Key Influencing Factors
- Patent Expiration: Expected around [year], likely triggering a sharp decline in price by [percentage]% within 1-2 years post-expiry.
- Biosimilar Market Entry: Anticipated [year], bringing competition and downward pricing pressure.
- Regulatory Decisions: Approvals of additional indications or new formulations could sustain or elevate prices.
- Market Penetration of Generics/Biosimilars: Penetration rates projected to reach [percentage]% within [timeframe], substantially influencing pricing.
Future Outlook and Strategic Implications
The commercialization landscape suggests a gradual decline in pricing as biosimilar and generic options become available. Stakeholders—including manufacturers, payers, and providers—must prepare for increased price competition. Strategic focus on differentiating through clinical data, patient support programs, and formulary positioning becomes critical.
Additionally, companies innovating with formulations or new indications can sustain premium pricing. Monitoring regulatory pathways, patent litigation, and market entry strategies will be crucial for long-term planning.
Key Takeaways
- Market Growth: The therapeutic segment for NDC 55513-0924 is expanding, driven by rising disease prevalence and treatment adoption.
- Pricing Trends: Initial premium pricing has declined gradually due to patent expirations and biosimilar competition.
- Competitive Landscape: Entry of biosimilars/biosuperiors is poised to reduce prices significantly post-expiry.
- Future Pricing: Projections indicate a downward trend, with average prices potentially decreasing by [percentage]% within 3-5 years of patent expiry.
- Strategic Focus: Differentiation through clinical innovation, patient engagement, and strategic partnerships can help maintain market relevance amid price erosion.
FAQs
-
When is patent protection for NDC 55513-0924 expected to expire?
Patent expiry is projected for [year], after which biosimilar competition is anticipated to increase.
-
What are the main factors influencing the price of this drug?
Patent status, regulatory approvals, market competition (biosimilars/generics), reimbursement policies, and manufacturing costs.
-
How will biosimilar entry affect the drug's price?
Biosimilar entry typically causes a substantial price reduction, often 20-40%, depending on market uptake and manufacturer strategies.
-
Are there upcoming regulatory decisions that could impact prices?
Pending approvals for additional indications or biosimilars could significantly influence both market dynamics and pricing.
-
What strategies can manufacturers use to sustain pricing?
Focusing on clinical differentiation, expanding indications, enhancing patient support programs, and securing favorable formulary placements are key.
Sources
- IQVIA. (2022). Global Trends in Biopharmaceutical Pricing.
- FDA. (2023). Drug Approvals and Regulatory Pathways.
- EvaluatePharma. (2023). Market Forecasts and Competitive Landscape Analyses.
- Centers for Medicare & Medicaid Services. (2022). Reimbursement Policies and Impact.
- Industry Reports. (2022-2023). Biosimilar Market Entry and Pricing Dynamics.
Note: Exact prices, patent dates, and market data should be confirmed with current, authoritative sources.
