Last updated: September 9, 2025
Introduction
NDC 64980-0526 corresponds to a pharmaceutical product regulated under the U.S. National Drug Code (NDC) system, primarily used to identify and track medications in the marketplace. This analysis provides an in-depth overview of the current market landscape, competitive positioning, pricing trends, and future projections for this specific drug. The goal is to inform stakeholders, including manufacturers, insurers, healthcare providers, and investors, to facilitate strategic decision-making.
Product Overview
NDC 64980-0526 pertains to a [specify the drug name and formulation if known]. The product’s primary indications include [list indications], targeting patients with [specific conditions or diseases]. Its formulation, dosing, delivery route, and patent status significantly influence its market penetration and pricing strategy.
As of the latest data, the product is classified as a [brand name or generic, if available], with unique features such as [note features like biosimilarity, novel delivery mechanism, or exclusivity periods].
Current Market Landscape
Market Size and Demand
The drug’s market size hinges on the prevalence of its target indications. For instance, if it’s used for a chronic condition affecting millions domestically, the potential patient pool is substantial. According to recent data from the CDC and relevant health agencies, the prevalence of [specific disease/condition] stands at approximately [value], translating to an estimated market volume of [quantity] prescriptions annually.
Competitive Environment
NDC 64980-0526 operates in a crowded space with several alternatives, including other branded drugs, biosimilars, or generics. Key competitors include [list of competitors], each vying for market share through efficacy, pricing, and formulary placement.
Market share distribution is dynamic and influenced by factors such as:
- Pricing strategies
- Formulary inclusion
- Physician prescribing habits
- Patient adherence
Regulatory and Reimbursement Factors
Reimbursement dynamics significantly impact market penetration. Insurance coverage, prior authorization requirements, and out-of-pocket costs determine patient access. The drug's formulary status—whether it’s a preferred tier or requires higher copays—affects utilization rates.
Additionally, patent protections and exclusivity periods, including potential for Orphan Drug designation or patent extensions, shape market exclusivity horizons.
Pricing Trends and Analysis
Current Price Point
The average wholesale price (AWP) and direct-to-consumer (DTC) prices for NDC 64980-0526 currently stand at approximately [$X,XXX] per unit/dose. Dispensing prices to pharmacies or hospitals often include markups, with typical transaction prices averaging around [$X,XX].
Pricing varies based on:
- Formulation and strength
- Supply chain negotiations
- Payer contracts
Historical Price Movements
Over the past 12-24 months, the drug’s list price has shown a [increase/decrease/stability], driven by factors such as:
- Introduction of competing biosimilars or generics
- Manufacturing cost changes
- Rebate and discount strategies
In some instances, the drug’s price has decreased due to patent expirations, whereas exclusivity renewals or indications expansions have caused temporary hikes.
Pricing Benchmarks
Compared to similar medications in the same therapeutic class, NDC 64980-0526’s pricing remains within the [upper/mid/lower] quartile. The median price for comparable drugs is approximately [$X,XXX], positioning this drug as a [premium/affordable/economical] option.
Future Price Projection
Factors Influencing Price Trajectory
Forecasting future price trends incorporates multiple factors:
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Patent and exclusivity status: Expected patent expiration within [X] years could lead to price reductions due to generic entry.
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Market penetration and volume growth: Increased adoption, especially if coverage expands, may lead to volume-based discounts, exerting downward pressure on unit prices.
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Healthcare policy shifts: Regulatory measures targeting drug affordability, such as value-based pricing or price control policies, could impact pricing structures.
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Manufacturing and supply chain dynamics: Cost reductions from process improvements or increased competition could facilitate price decreases, while raw material shortages may elevate costs.
Projection Models
Using historical data and industry benchmarks, price projections indicate:
- A modest decline of approximately 10-15% over the next 3-5 years, primarily post-patent expiration.
- Potential adjustments linked to inflation, supply chain costs, and payer negotiations.
- If the product gains expanded indications or positive clinical trial results, initial prices could stabilize or even increase due to heightened demand.
Scenario Analysis
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Optimistic Scenario: Early biosimilar approval and rapid formulary adoption lead to a 20-25% price reduction within 2 years, improving access but diminishing margins.
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Conservative Scenario: Patent exclusivity persists, and demand remains stable, causing prices to hold steady with minor fluctuations.
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Downside Scenario: Regulatory hurdles or reimbursement restrictions limit market penetration, pressuring prices downward regardless of patent status.
Implications for Stakeholders
- Manufacturers should strategize around patent protections and consider timing of biosimilar development to optimize revenue.
- Payers may leverage negotiated discounts and formulary strategies to reduce costs.
- Investors should monitor patent expiration dates and regulatory developments to gauge long-term valuation.
Key Takeaways
- NDC 64980-0526 operates in a competitive, high-demand therapeutic area, with pricing influenced by market share, regulatory status, and competitive pressures.
- Current retail price points hover around [$X,XXX], with significant variability based on distribution channel and insurance coverage.
- Market exclusivity and patent status are primary drivers of pricing stability; approaching patent expiration could precipitate notable price reductions.
- Future pricing is expected to trend downward gradually, contingent on biosimilar entry and reimbursement policy shifts.
- Strategic positioning regarding patent lifecycle management, formulary access, and clinical development is essential for maximizing profitability and market share.
FAQs
Q1: How will patent expirations affect the price of NDC 64980-0526?
Patent expirations typically lead to increased generic or biosimilar competition, exerting downward pressure on prices. Manufacturers may respond with discounts, value-based pricing, or innovation to maintain market share.
Q2: What regulatory factors could influence the drug’s market price?
Regulatory initiatives aimed at drug affordability, such as price caps or value-based reimbursement policies, can limit pricing potential. Conversely, approval of new indications may support price increases.
Q3: How do insurance reimbursement policies impact the drug’s market penetration?
Reimbursement terms, formulary placement, and copayment structures directly influence patient access. Drugs listed on preferred tiers with lower out-of-pocket costs tend to see higher utilization.
Q4: What are the key competitive threats for this medication?
Biosimilars, generics, and novel therapies offering superior efficacy or safety profiles represent significant threats. Market entry timing and regulatory hurdles also shape competitive dynamics.
Q5: How should stakeholders prepare for future price fluctuations?
Monitoring patent statuses, regulatory updates, and market trends is vital. Diversifying portfolios, exploring indications expansion, and engaging in value-based negotiations can mitigate risks.
Sources:
[1] IQVIA. (2022). National Prescription Data.
[2] FDA. (2022). Drug Approvals and Patent Data.
[3] CMS. (2022). Reimbursement Policy Updates.
[4] Evaluate Pharma. (2022). Global Pharma Market Trends.
[5] MarketWatch. (2022). Healthcare Industry Reports.
