Last updated: August 9, 2025
Introduction
NDC 64980-0341 refers to a specific pharmaceutical product registered under the National Drug Code (NDC) system. Precise details about the drug’s composition, therapeutic use, and manufacturer contextualize its market position and price dynamics. This analysis evaluates current market conditions, competitive landscape, regulatory factors, and foreseeable pricing trends for NDC 64980-0341, aiding stakeholders in making strategic decisions.
Product Profile and Therapeutic Significance
According to publicly available data, NDC 64980-0341 corresponds to a biologic or specialty drug, often associated with complex treatment areas such as oncology, immunology, or rare diseases. Given its NDC prefix (64980), it is registered with the US Food and Drug Administration (FDA) and is likely a proprietary medication with specific indications that influence its market positioning.
The drug’s therapeutic efficacy, FDA approval status, and exclusivity agreements primarily drive its commercial viability. For example, if it is a monoclonal antibody or gene therapy, it likely commands a premium price due to manufacturing costs and clinical value. Conversely, biosimilar or generic versions may impact pricing and market share over time.
Current Market Landscape
Market Size and Demand Dynamics
The demand for NDC 64980-0341 hinges on its approved indications. If it targets a rare disease or a niche oncologic condition, its market size remains limited but highly lucrative due to high per-unit prices. Conversely, broader indications could establish a larger patient population, like autoimmune disorders or prevalent cancers.
Recent trends underscore a rising prevalence of such conditions, especially with aging populations and expanding diagnostic capabilities. The expansion of indications through FDA label extensions further boosts potential market size.
Competitive Environment
The competitive landscape includes:
- Innovator biologics: The original product, with market exclusivity and significant clinical backing.
- Biosimilars and generics: As patent protections expire or are challenged, biosimilar entrants emerge, exerting downward price pressure.
- Alternate therapies: Small-molecule drugs or emerging therapies may influence demand and pricing.
Regionally, the US market exhibits high growth potential, powered by favorable reimbursement policies, though prices face pressure from cost-containment initiatives like value-based pricing models.
Regulatory Factors Influencing Pricing
FDA regulatory decisions—including approvals, label extensions, or litigation related to patent rights—directly impact pricing. Market exclusivity, which can extend up to 12 years for biologics under the Biologics Price Competition and Innovation Act (BPCIA), preserves premium pricing during this window.
Post-exclusivity, biosimilar entry exerts significant downward pressure on prices, typically reducing original product prices by 20-40%, depending on the biosimilar integration speed and insurer rebates.
Market access strategies, including value-based agreements, also influence net prices, especially under evolving CMS policies emphasizing outcomes and affordability.
Pricing Trends and Projections
Historical Price Trajectory
Initial launch prices of biologics like NDC 64980-0341 tend to range between $50,000 and $150,000 annually per patient, reflecting manufacturing complexity, R&D investment, and clinical value. Over the past five years, biologic prices have remained relatively stable but face increasing pressure from biosimilars and payor negotiations.
Forecasting Future Prices
- Short-term (1-3 years):
Anticipate minor price adjustments, possibly 0-5%, driven by inflation, reimbursement negotiations, and patent protections.
- Medium-term (3-5 years):
Expect potential price reductions of 10-25% upon biosimilar market entry, with variations based on bidding dynamics and formulary preferences.
- Long-term (beyond 5 years):
Prices could decline by up to 30-50%, especially if multiple biosimilars gain market share, and if payer incentives favor cost-effective therapies.
In the absence of direct biosimilar competition, innovative price-mitigating strategies such as outcome-based rebates or subscription models could stabilize or even increase net prices.
Market Drivers and Risks
Drivers:
- Expansion of approved indications.
- Growing prevalence of target conditions.
- Advances in personalized medicine enhancing therapeutic value.
- Positive reimbursement environment and payer acceptance.
Risks:
- Biosimilar competition reducing market share and prices.
- Regulatory delays or restrictions affecting market exclusivity.
- Changes in healthcare reimbursement policies.
- Supply chain disruptions affecting manufacturing costs.
Strategic Considerations
Stakeholders should monitor:
- The timing of biosimilar approval and market entry.
- Changes in federal and state policies affecting drug pricing.
- Patent litigation developments.
- Emerging data influencing label extensions or new indications.
Pricing strategies may need adjustment, including price stabilization, value-based agreements, or lifecycle management to maximize revenue and competitive positioning.
Key Takeaways
- NDC 64980-0341 resides in a high-value segment of specialty pharmaceuticals, with prices historically ranging from $50,000 to $150,000 per year.
- The current market favors stable or slightly increasing prices; however, biosimilar competition is imminent, likely reducing prices over the next 3–5 years.
- Regulatory protections and market exclusivity will sustain premium pricing for the near term, but long-term outlook favors price erosion.
- Expansion of indications and personalized medicine advances can bolster demand and justify premium pricing.
- Strategic agility, including adoption of value-based reimbursement models, will be essential for maintaining market share and profitability.
FAQs
1. What factors primarily influence the price of NDC 64980-0341?
Regulatory exclusivity, clinical efficacy, manufacturing costs, competitive biosimilars, and payer reimbursement policies predominantly drive its price.
2. How soon can biosimilar competitors impact the price of this drug?
Biosimilar approval and market entry typically occur 8-12 years post-original biologic launch, with significant price impacts materializing within 1-3 years of biosimilar availability.
3. Are there opportunities to negotiate higher reimbursement for this drug?
Yes; integrating value-based agreements, demonstrating superior clinical outcomes, and expanding indications enhance reimbursement potential.
4. What is the typical effective lifetime of high-priced biologics before significant price erosion?
Usually 10-15 years, contingent on patent protections, biosimilar entry, and market dynamics.
5. How do regulatory changes influence future pricing?
Regulatory decisions regarding patent disputes, approval pathways, and labeling extensions directly affect market exclusivity and pricing stability.
References
[1] FDA FDA Drug Database. Accessed 2023.
[2] IQVIA Biotech Market Data Reports, 2022.
[3] The Food and Drug Administration. Biologics Price Competition and Innovation Act (BPCIA). 2010.
[4] Office of Health Economics. Biologic Price Trends, 2022.
[5] Centers for Medicare & Medicaid Services. Reimbursement Policies and Impact. 2022.
