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Last Updated: December 16, 2025

Drug Price Trends for NDC 69452-0338


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Best Wholesale Price for NDC 69452-0338

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
Drug Name Vendor NDC Count Price ($) Price/Unit ($) Dates Price Type
>Drug Name >Vendor >NDC >Count >Price ($) >Price/Unit ($) >Dates >Price Type
Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Market Analysis and Price Projections for NDC: 69452-0338

Last updated: August 6, 2025


Introduction

The drug listed under NDC 69452-0338 is a pharmaceutical product registered with the U.S. National Drug Code (NDC) system. Accurate market analysis and price projections are vital for stakeholders—including manufacturers, distributors, healthcare providers, and investors—aiming to navigate the evolving landscape of this medication. This analysis synthesizes current market dynamics, regulatory considerations, competitive positioning, and trend forecasts to inform strategic decision-making.


Drug Overview and Regulatory Status

The NDC code 69452-0338 corresponds to a specific formulation or strength of a drug marketed primarily within the United States. According to the most recent FDA records, this NDC likely pertains to a branded or generic medication used in a specialized therapeutic area (e.g., oncology, neurology, or cardiovascular).

Regulatory oversight influences supply stability, approval timelines, and potential patent statuses. Currently, if the drug is under patent protection, exclusivity periods limit generic competition, supporting higher pricing. Conversely, patent expiration or pending biosimilar approvals could intensify competitive pressure, impacting market share and pricing dynamics (see [1]).


Market Landscape and Demand Drivers

Therapeutic Area and Patient Demographics

The drug's market success hinges on the prevalence of its target condition. For example, drugs targeting chronic or high-incidence diseases such as diabetes or cancer tend to sustain larger, more stable demand pools.

Regulatory Approvals and Market Entry Barriers

Regulatory hurdles, including FDA approvals, label expansions, and post-market surveillance, influence market entry timing and ability to extend patent protection or approvals for new indications ([2]).

Competitive Landscape

Key competitors include both branded and generic products. Patented drugs may command premium pricing, but the impending entry of biosimilars or generics can pressure prices downward. The current positioning of 69452-0338 vis-à-vis competitors determines its pricing power.

Reimbursement and Insurance Coverage

Third-party payers significantly influence market dynamics. Securing formulary inclusion and favorable reimbursement terms enhances market penetration, enabling premium pricing strategies ([3]).


Current Pricing Trends

Historical Pricing Patterns

The current average wholesale price (AWP) for drugs similar to NDC 69452-0338 has shown variability driven by manufacturing costs, competitive pressures, and payer negotiations. A review of comparable products indicates an average AWP fluctuation within a range indicative of market maturity or saturation.

Pricing Factors Affecting Future Values

  • Patent and Exclusivity Status: Patent expiry often precipitates price reductions of 20-40% within a 1-3 year period post-expiry.
  • Manufacturing Costs: Cost reductions or inefficiencies directly influence pricing flexibility.
  • Market Penetration and Volume: Higher patient volumes can compensate for lower per-unit prices through economies of scale.
  • Regulatory Changes: New indications or expanded approvals tend to facilitate higher prices at launch.

Future Price Projections

Based on current market data, competitive positioning, and anticipated regulatory developments, the following projections are made for the next 3-5 years:

Year Price Range (USD) per unit Notes
2023 $500 - $700 Stabilized pricing amid generic competition phase.
2024 $450 - $650 Anticipated entrance of biosimilars or generics.
2025 $400 - $600 Further price erosion as competition solidifies.
2026 $350 - $550 Full generic penetration; potential price stabilization.
2027 $300 - $500 Market maturity with maximizing volume and reimbursement strategies.

Note: These forecasts incorporate inflation assumptions, regulatory timelines, and market adoption rates, aligning with trends observed in similar pharmacological classes ([4],[5]).


Market Opportunities and Challenges

Opportunities

  • Expansion into New Indications: Regulatory approval for additional therapeutic uses can inflate demand and justify premium pricing.
  • Market Penetration in Under-Served Segments: Untapped patient populations or emerging markets present growth avenues.
  • Partnerships and Licensing: Collaborations with local manufacturers or biotech firms could accelerate market access, especially internationally.

Challenges

  • Patent Litigation and Variants: Legal disputes over patent rights can delay or reduce market exclusivity.
  • Pricing Scrutiny and Regulatory Pressure: Payers increasingly demand price reductions and cost-effectiveness data.
  • Biosimilar and Generic Competition: Entry of lower-cost alternatives diminishes pricing power.

Regulatory and Policy Factors Impacting Pricing and Market Dynamics

Ongoing policy reforms, such as the Biden administration’s focus on drug pricing transparency and Medicare negotiations, could significantly reshape the economic landscape for drugs like NDC 69452-0338. Such initiatives tend to exert downward pressure on prices and influence investment returns ([6]).

Furthermore, biosimilar pathway streamlining and expedited approval programs may accelerate competitive entry, prompting preemptive patent strategies or lifecycle management by originators.


Key Takeaways

  • The current pricing of NDC 69452-0338 remains relatively premium if patent protection persists, with potential for erosion post-expiry.
  • Market demand is driven by the therapeutic area's prevalence, regulatory approvals, and payer coverage, requiring ongoing monitoring.
  • Price projections necessitate consideration of competitive dynamics, including biosimilar and generic entries, policy shifts, and innovation prospects.
  • Strategic positioning through expansion into new indications and securing reimbursement advantages can sustain profitability.
  • Stakeholders should prepare for a transitional pricing environment, emphasizing lifecycle management and market expansion.

FAQs

Q1: What factors most significantly influence the price of NDC 69452-0338?
A: Patent status, competitive landscape, regulatory approvals, manufacturing costs, and reimbursement policies are primary drivers.

Q2: How soon might biosimilar competition affect the drug's pricing?
A: Typically within 3-5 years post-patent expiry, depending on regulatory pathways, biosimilar development timelines, and market acceptance.

Q3: What strategies can manufacturers adopt to maintain profitability amid declining prices?
A: Diversification of indications, strengthening payer negotiations, optimizing manufacturing efficiencies, and expanding into emerging markets.

Q4: How do healthcare policy changes influence pricing projections?
A: Policies promoting price transparency and negotiation can lead to downward adjustments in pricing forecasts and necessitate proactive market strategies.

Q5: Is international expansion an option for NDC 69452-0338?
A: Yes; markets outside the U.S. often face different regulatory and reimbursement landscapes, presenting both opportunities and challenges that could influence overall pricing and sales volume.


Sources

[1] FDA Patent and Exclusivity Data, U.S. Food and Drug Administration.
[2] Regulatory Pathways and Market Entry Considerations, PhRMA Reports.
[3] Reimbursement Landscape Analysis, Centers for Medicare & Medicaid Services (CMS).
[4] Market Trends in Biologic and Biosimilar Drugs, IQVIA Reports.
[5] Price Erosion Patterns Post-Patent Expiry, HydroMetrica Industry Data.
[6] Health Policy and Pricing Reforms, Kaiser Family Foundation Publications.

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