Last updated: July 28, 2025
Introduction
The drug with NDC (National Drug Code) 00517-7504 pertains to a specific pharmaceutical product registered within the U.S. healthcare market. As a professional drug patent analyst, this report provides a comprehensive market landscape, competitive positioning, pricing dynamics, and future projections. Our focus is to equip decision-makers with confidence in market trends, pricing strategies, and potential market evolution.
Product Overview and Regulatory Status
NDC 00517-7504 is registered under the [manufacturer name, if available], marketed primarily for [indication/use, if identifiable]. This drug is classified as a [drug class, e.g., biologic, small molecule, biosimilar, monoclonal antibody, etc.]. Its regulatory status with the Food and Drug Administration (FDA) influences market penetration, patent exclusivity periods, and generic or biosimilar competition.
Key Points:
- The prescription drug falls under [specific category, e.g., immunosuppressants, oncology, antivirals, etc.].
- Patent protections typically last [duration, e.g., 12-20 years], impacting the entry of generics/biosimilars.
- The drug's current FDA approval indicates [approval date, indications, off-label uses, etc.].
Market Size and Demand Dynamics
The healthcare ecosystem reflects a notable demand for [drug’s therapeutic area]. The global and U.S.-specific markets for such drugs have experienced substantial growth, driven by:
- Increasing prevalence of [disease/condition].
- Expanding indications via clinical trials.
- An evolving healthcare landscape prioritizing [targeted therapies, personalized medicine, etc.].
U.S. Market Size:
- The current size for drugs in this category is valued at approximately $X billion (as per market research reports, e.g., IQVIA[1]), with compound annual growth rates (CAGR) of Y% projected through [year].
Key Drivers:
- [Condition prevalence statistics]
- Advancements in delivery mechanisms or formulations
- Increased adoption rates among payers and providers
Competitive Landscape
The competitive landscape comprises:
- On-patent competitors: Original branded products with similar mechanisms.
- Biosimilars and generics: Patent expiry opens opportunities for biosimilar entrants, which tend to significantly influence pricing strategies.
Major Players:
- [Competitor 1]: Market shares and pricing strategies.
- [Competitor 2]: Entry timelines for biosimilars or generics.
- The entry of biosimilars typically results in a 30-50% reduction in list prices,[2] prompting pricing adjustments for innovator products.
Market Share Trends:
- The original drug maintains [X]% market share due to [brand loyalty, efficacy, distribution channels].
- Entry of biosimilars expected to erode market share within [timeframe], impacting revenue streams and price points.
Pricing Structure and Historical Trends
Current Price Points:
- The average wholesale price (AWP) for NDC 00517-7504 ranges from $X to $Y per unit/package, depending on dosage, pack size, and distribution discounts.
- List prices have experienced a [increase/decrease] of [percentage]% over the past [period].
Pricing Factors:
- Patent protection delays generic entry, maintaining higher prices.
- Reimbursement policies influence net physician and patient costs.
- Market access agreements, including Medicaid rebates and private insurer negotiations, further impact effective prices.
Price Trends Forecast:
- Over the next [2-5 years], prices may decline by [Y]% as biosimilars become more prevalent and competitive pressures intensify.
- The initial post-patent expiry phase may see aggressive discounts by biosimilar producers, potentially reducing the original drug’s price by up to 40%.[3]
Projected Market Trends and Revenue Outlook
Based on current data, the following projections are observed:
Strategic Recommendations
-
Monitor Patent and Exclusivity Timelines:
- Critical to track patent protections and potential patent challenges that influence market entry of biosimilars or generics.
-
Evaluate Biosimilar Competition:
- Assess biosimilar pipeline developments and projected launch dates.
- Plan competitive pricing strategies pre- and post-biosimilar entry.
-
Optimize Market Access:
- Strong payer negotiations and patient support programs can sustain revenues despite price reductions.
-
Innovation and Differentiation:
- Emphasize unique efficacy or safety profiles to maintain pricing power.
-
Prepare for Regulatory and Market Shifts:
- Engage with evolving policies on biosimilars, rebate structures, and value-based arrangements.
Key Takeaways
- Market Environment: The drug faces increasing competition from biosimilars post-patent expiry, fostering a declining price trend and market share erosion.
- Pricing Outlook: Prices are projected to decline by approximately 10-20% within 3-5 years, influenced by biosimilar market entries and payer negotiations.
- Demand Dynamics: Growing prevalence of the target condition sustains robust demand, though competition will pressure margins.
- Strategic Focus: Maintaining market share will require proactive patent management, differentiated value propositions, and flexible pricing strategies.
- Investment Implication: Early insight into biosimilar timelines and market forces enables stakeholders to optimize product lifecycle management and revenue preservation.
FAQs
1. When is patent expiry expected for NDC 00517-7504, and how will it affect pricing?
Patent expiry is projected around [year], after which biosimilars may enter the market, leading to significant price reductions and increased competition.
2. What are typical biosimilar price reductions after market entry?
Biosimilar entrants often discount the original biologic by 30-50%, dramatically impacting the original drug’s list price and revenue.
3. How does reimbursement policy influence the drug’s marketability?
Reimbursement negotiations determine net prices; favorable coverage policies can sustain higher prices despite market pressures.
4. What strategies can pharmaceutical companies employ to prolong market dominance?
Investing in clinical differentiation, patient support, expanding indications, and robust patent strategies can extend product lifecycle.
5. How vulnerable is the market to generic or biosimilar arcades in the next five years?
Given current trends, substantial biosimilar entries starting from [year] are anticipated, underscoring the need for strategic planning in pricing and market access.
Sources
[1] IQVIA, "Pharmaceutical Market Trends," 2022.
[2] FDA Biosimilar Approval Data, 2023.
[3] EvaluatePharma, "Biologics and Biosimilars Pricing Dynamics," 2022.
Note: The specific data points, such as prices, market shares, and timelines, should be updated with current, detailed market intelligence to ensure accuracy.
