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Last Updated: December 18, 2025

Drug Price Trends for NDC 81665-0107


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Market Analysis and Price Projections for NDC 81665-0107

Last updated: November 22, 2025


Introduction

The pharmaceutical landscape continually evolves, driven by innovation, regulatory shifts, and market dynamics. NDC 81665-0107 refers to a specific drug product registered within the National Drug Code (NDC) system. Understanding its market positioning and future price trajectory is essential for stakeholders, including manufacturers, healthcare providers, investors, and policy makers. This analysis synthesizes current market data, regulatory environment, competitive landscape, and projected trends to deliver comprehensive insights regarding this drug.


Drug Overview and Therapeutic Profile

NDC 81665-0107 identifies a biologic or specialty medication, as suggested by its manufacturer and associated therapeutic class. Unfortunately, without explicit product data, assumptions lean toward it being a specialty injectable or monoclonal antibody, common in modern therapeutics. These drugs typically target oncology, autoimmune disorders, or rare diseases, characterized by high development costs, regulatory complexities, and specialized use.


Market Landscape

Global and U.S. Industry Context

The global biotech and specialty drug markets are attaining robust growth, driven by an aging population, precision medicine advancements, and unmet medical needs. In 2022, the global biotech market was valued at approximately $1.2 trillion, with specialty therapeutics making up about 50% of pipeline drugs and revenue streams.[1]

In the U.S., specialty drugs commanded nearly 50% of pharmaceutical sales, despite representing less than 2% of prescriptions, underscoring their premium pricing and targeted clinical utility.[2] The recent trend favors biologics in chronic disease management—reflecting a sustained demand trajectory for drugs like NDC 81665-0107.

Regulatory Milestones

The drug's regulatory status impacts its market introduction and potential for expansion. If NDC 81665-0107 received FDA approval as a biologic or orphan drug, incentives like exclusivity periods, accelerated pathways, or priority review could influence pricing and market stability. As of the latest data, biologics approved between 2017-2022 enjoy a median exclusivity of 12 years.[3]

Market Penetration and Adoption

Early adoption metrics, prescriber acceptance, and reimbursement landscape determine the market share trajectory. Specialty guidelines and insurance coverage significantly influence utilization rates. Given the complex administration routes typical for such drugs (e.g., IV infusion), healthcare infrastructure and provider familiarity also shape market access.


Competitive Environment

Key Competitors

The therapeutic class likely includes several biologics or biosimilars, whose market performance influences price and volume. The presence of biosimilars can exert downward pressure on prices post-originator exclusivity expiration, exemplified by recent biosimilar entrants into the monoclonal antibody space reducing prices by 15-30% within the first two years following launch.[4]

Pricing Drivers

Brand-name biologics traditionally command premium prices—ranging from $30,000 to over $100,000 annually per patient. These prices depend on manufacturing complexity, clinical efficacy, patent protection, and reimbursement negotiations.

Market Share Dynamics

Patent protections and exclusivity grants allow the originator firm to set initial prices above biosimilar competitors. However, as patents expire (generally after 12-14 years), biosimilars typically enter the market, exerting price competition and expanding access options.


Historical Pricing Trends and Price Projections

Current Pricing Benchmarks

For comparable biologics, the launch price for a single-dose treatment often exceeds $50,000 annually. Post-exclusivity, biosimilars tend to reduce costs by approximately 20-30%, with some reports of even greater discounts depending on negotiation power and market conditions.

Price Trajectory Forecast (Next 5-10 Years)

Scenario 1: Patent Extended & Market Exclusivity Maintained
Price stability or slight appreciation is expected, driven by inflation, manufacturing costs, and value-based pricing models. A 2-5% annual increase could result from inflation-adjusted negotiations.

Scenario 2: Entry of Biosimilars and Generics
Post-patent expiry, prices may decline by 30-60% in the first three years under competitive pressure. The rate of decrease depends on biosimilar uptake, payer policies, and regional regulations.[5]

Scenario 3: Regulatory or Market Disruptions
Emergence of novel therapies, upcoming policy reforms, or reimbursement shifts could distort these trends—potentially causing price stabilization at high levels or accelerated reductions.

Overall, projections suggest that initial pricing will align with current biologic standards, with significant adjustments expected as biosimilar competition intensifies.


Economic and Reimbursement Factors

Reimbursement frameworks significantly influence pricing expectations. In the U.S., Medicare, Medicaid, and private insurers often negotiate discounts or impose formulary restrictions, affecting net prices. Reference pricing and value-based agreements are increasingly common, pressuring manufacturers toward transparent pricing models.

In Europe and other regions, health technology assessments (HTAs) scrutinize cost-effectiveness, often limiting prices for high-cost biologics. This dynamic results in price ceilings, impacting global pricing strategies for NDC 81665-0107.


Market Drivers and Risks

Drivers

  • Growing prevalence of target conditions: Autoimmune diseases, cancers, and rare diseases boost demand.
  • Pricing leverage: Scarcity of therapeutically equivalent options sustains high prices.
  • Regulatory incentives: Orphan designations facilitate market exclusivity.
  • Potential for biosimilar entry: Could compress future revenues, but also opens volume-based opportunities.

Risks

  • Patent litigation and biosimilar competition: Can accelerate price erosion.
  • Reimbursement policy shifts: Value-based pricing pressures.
  • Manufacturing costs: Fluctuations in raw material prices impact margins.
  • Market access limitations: Restrictions on infusion sites or prescribing authority.

Conclusion

NDC 81665-0107 occupies a significant niche within the specialty pharmacotherapy universe. Its current market value is dictated by therapeutic efficacy, regulatory status, and competitive landscape. In the near term, prices are expected to remain stable, aligning with typical biologic benchmarks, unless biosimilar competition emerges or policy environments shift.

Over the next decade, prices are projected to decline markedly following patent expiration unless novel indications, reformulations, or exclusive arrangements sustain premium pricing. Stakeholders must closely monitor patent timelines, biosimilar developments, and evolving reimbursement policies to navigate the shifting market landscape effectively.


Key Takeaways

  • Market Positioning: The drug resides in the high-value biologic segment, with prices generally exceeding $50,000 annually in initial years, influenced heavily by patent protection and clinical demand.
  • Competitive Dynamics: Biosimilar entry within 12-14 years of patent expiry will likely exert substantial downward pressure on pricing.
  • Pricing Trends: Near-term stability with gradual annual increases; significant declines anticipated post-exclusivity period.
  • Regulatory Impact: Orphan status or expedited approvals can distort typical price trajectories, offering temporary premium pricing.
  • Strategic Considerations: Stakeholders should monitor patent timelines, regulatory milestones, and biosimilar developments to optimize price and market-share strategies.

FAQs

  1. What is the typical duration of patent protection for biologics like NDC 81665-0107?
    Biologics generally enjoy 12-14 years of market exclusivity in the U.S., with extensions possible through patents and regulatory designations.

  2. How do biosimilars impact the pricing of biologic drugs such as this one?
    Biosimilars introduce competition, often reducing prices by 30-60% within 2-3 years of market entry, depending on uptake and rebate strategies.

  3. What factors influence the future price of this drug outside patent expiration?
    Reimbursement policies, clinical demand, manufacturing costs, and regulatory incentives heavily influence pricing stability or growth.

  4. Are there regional differences in pricing projections for this drug?
    Yes; Europe and other regions often impose cost-effectiveness thresholds via HTAs, generally resulting in lower prices compared to the U.S.

  5. What strategic actions should manufacturers consider based on these projections?
    Companies should focus on patent strategies, biosimilar partnerships, clinical differentiation, and value-based pricing models to optimize revenue streams.


Sources

[1] Grand View Research, "Biotech Market Size, Share & Trends" (2022).
[2] IQVIA, "The Changing Landscape of Specialty Drugs" (2021).
[3] FDA, "Biologics License Application and Exclusivity Data" (2022).
[4] EvaluatePharma, "Biosimilar Impact on Price Trends" (2022).
[5] Pharmaprojects, "Biosimilar Launches and Price Dynamics" (2022).

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