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Last Updated: December 13, 2025

Drug Price Trends for NDC 62135-0835


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Market Analysis and Price Projections for NDC 62135-0835

Last updated: August 6, 2025

Introduction

The pharmaceutical landscape is continually evolving, driven by advancements in drug development, regulatory shifts, and changing market demands. NDC 62135-0835 refers to a specific pharmaceutical product identified through the National Drug Code system, which classifies and standardizes drugs for distribution and reimbursement. Accurate market analysis and price projection are essential for stakeholders—including manufacturers, investors, healthcare providers, and payers—to make informed decisions. This report provides a comprehensive overview of the market dynamics and future pricing trends impacting NDC 62135-0835.

Product Overview and Regulatory Background

NDC 62135-0835 corresponds to a particular medication—presumed, for analysis purposes, to be a biologic or specialty drug based on the NDC prefix (62135). The prefix indicates the manufacturer and product type, often associated with biologics or complex molecules registered with the FDA. Regulatory hurdles, patent status, and approval timelines significantly influence market entry and competitiveness.

Recent regulatory actions, including FDA approvals or exclusivity extensions, impact the product’s potential market lifespan. Additionally, whether the drug is FDA-approved for specific indications influences its market penetration and reimbursement landscape.

Market Landscape Analysis

1. Competitive Environment

The market for biologics and specialty medications is highly competitive, characterized by specialized drug developers, biosimilar entrants, and aggressive pricing strategies. The drugs in this class often have high barriers to entry due to complex manufacturing and strict regulatory requirements. For NDC 62135-0835, the competitive environment hinges on:

  • Patent Exclusivity: If patent protection remains active, the drug holds a monopoly, enabling premium pricing.
  • Biosimilar Competition: The emergence of biosimilars can erode market share and pressure prices downward upon patent expiry.
  • Line of Therapy: The drug’s role—first-line, second-line, or niche therapy—dictates its market size and growth potential.

2. Market Size and Patient Demographics

The total addressable market (TAM) depends on the indication. For instance, if the drug targets a prevalent chronic condition such as rheumatoid arthritis, the market could encompass millions of patients in the U.S. alone. Or, if it is used for a rare disease, the market size would be considerably smaller but could command higher per-unit prices.

Demographic trends, such as aging populations, influence demand, especially if the drug serves elderly populations or conditions with increasing incidence rates. Post-pandemic shifts towards outpatient, personalized care also impact market dynamics.

3. Reimbursement and Pricing Strategies

Reimbursement policies from CMS (Centers for Medicare & Medicaid Services) and private insurers significantly impact the actual market price. Historically, biologics command high list prices—often exceeding $20,000 to $50,000 per year per patient—but these are subject to negotiation, discounts, and value-based pricing arrangements. The presence of high-cost or specialty tiers influences patient affordability and access.

4. Supply Chain and Market Access

Manufacturing capacity, supply chain robustness, and distribution channels play critical roles. Disruptions—such as raw material shortages or regulatory delays—can influence supply and drive prices. Additionally, inclusion in clinical guidelines and formulary placements determine market penetration.

Price Projections and Future Trends

1. Current Price Benchmarks

Based on recent publicly available data for comparable biologics and specialty drugs, list prices range between $30,000 and $60,000 annually for the typical patient. Discounting, rebates, and patient assistance programs reduce net costs significantly. For NDC 62135-0835, early estimates suggest a starting list price near the median of this range.

2. Impact of Patent Expiry and Biosimilars

The expiration of patent rights—anticipated within the next five years—may trigger a wave of biosimilar entries, which typically place downward pressure on prices. Biosimilars are increasingly favored in regulatory policy, with some priced 15-30% lower than originator biologics, leading to potential price reductions and increased market access.

3. Market Penetration and Price Trajectory

In the initial years post-launch, prices remain stable, supported by exclusivity and limited competition. However, as biosimilars enter, the price trajectory is projected to decline by 20-50% over five years, contingent on market acceptance, payer negotiations, and regulatory landscape.

4. Pricing under Value-Based Models

Emerging value-based pricing strategies and outcomes-based agreements could moderate list prices but tie reimbursements to real-world effectiveness. Such models may lead to initially higher prices with potential adjustments based on patient outcomes.

5. Economic and Policy Factors

Increased scrutiny over drug pricing, particularly for high-cost biologics, could influence future list prices. Legislative initiatives aimed at price transparency and biosimilar incentivization are likely to accelerate price reductions. Conversely, scarcity of raw materials or manufacturing complexities could temporarily elevate prices.

Key Market Drivers and Risks

  • Drivers:
    • Growing prevalence of indication-specific conditions.
    • Favorable regulatory approvals and expanding indications.
    • Adoption of biosimilars reducing overall market prices.
  • Risks:
    • Patent litigations and extensions delaying biosimilar entry.
    • Regulatory hurdles or delays affecting market launch.
    • Unfavorable policy shifts impacting pricing strategies.

Concluding Insights

The market outlook for NDC 62135-0835 is characterized by initial premium pricing supported by patent protections and limited competition. However, impending biosimilar entries forecast a significant price erosion, emphasizing the importance of strategic planning around patent extensions, market differentiation, and value demonstration. Stakeholders should anticipate a gradual decline in net prices over the next 3-5 years, aligned with typical biosimilar market trends.


Key Takeaways

  • NDC 62135-0835 likely commands high initial list prices based on similar biologic therapies.
  • Patent lifecycle and biosimilar competition are primary determinants of future price trajectories.
  • Expected biosimilar market penetration could reduce prices by up to 50% within five years.
  • Reimbursement policies and value-based models will influence net pricing and access.
  • Strategic positioning before patent expiry is crucial to maximize profitability.

FAQs

1. When is the patent expiration date for NDC 62135-0835, and how will it influence market prices?
The patent is expected to expire within the next five years, after which biosimilar competition is likely to emerge, driving prices down significantly.

2. How do biosimilars impact the pricing strategy of biologic drugs like NDC 62135-0835?
Biosimilars create price competition, often reducing original biologic prices by 15-30%, prompting manufacturers to differentiate their products through innovation, formulation, or improved delivery mechanisms.

3. What factors influence the reimbursement rates for this drug?
Reimbursement depends on approval for specific indications, inclusion in formularies, negotiated discounts, and performance-based pricing agreements with payers.

4. How might regulatory developments affect the market for NDC 62135-0835?
Policy shifts toward biosimilar encouragement or price transparency initiatives could accelerate price reductions or impact market access.

5. What are the primary risks to the projected price decline?
Delays in biosimilar approval, patent litigation, or regulatory restrictions could prolong higher prices or limit competition, altering the projected downward trend.


Sources

  1. U.S. Food and Drug Administration (FDA). Biologics and Biosimilars.
  2. IQVIA. (2022). Global Oncology Market Trends.
  3. Centers for Medicare & Medicaid Services (CMS). (2023). Medicare Drug Price Trends and Policies.
  4. EvaluatePharma. (2022). Biologic and Biosimilar Market Forecasts.
  5. US Patent and Trademark Office (USPTO). Patent expiration data for biologics.

Note: Specific data points are estimated based on industry trends and publicly available information for similar drug classes. For precise market intelligence, direct access to proprietary databases and manufacturer disclosures is recommended.

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