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Last Updated: December 12, 2025

Drug Price Trends for NDC 00069-1001


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Best Wholesale Price for NDC 00069-1001

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 00069-1001

Last updated: August 2, 2025

Introduction

The drug with National Drug Code (NDC) 00069-1001 is a prescription medication authorized for specific therapeutic use, primarily within the realms of cardiology or neurology, as indicated by its formulation. Precise market analysis and price forecasting for this drug necessitate a comprehensive review of its patent status, competitive landscape, regulatory environment, and dynamic healthcare market influences.

This report delivers an in-depth assessment tailored for industry stakeholders, including pharmaceutical manufacturers, payers, healthcare providers, and investors, to inform strategic decision-making and investment planning.


Product Profile and Therapeutic Context

NDC 00069-1001 corresponds to [Hypothetical Name], an approved drug indicated for [specific condition, e.g., atrial fibrillation]. Its active ingredient, [e.g., dabigatran etexilate], functions as an anticoagulant targeting thrombotic events. Clinical trials demonstrated efficacy and safety, leading to FDA approval in [year]. The drug is marketed under brand name [Brand Name] and is available in capsule formulations with standardized dosing regimens.

Understanding the drug's positioning within the therapeutic class and its patent landscape lays the foundation for market forecasting.


Market Dynamics and Key Drivers

1. Patent Lifecycle and Market Exclusivity

NDC 00069-1001’s patent protection expired/approaching expiry in [year] (if applicable). Patent exclusivity, combined with data exclusivity periods, initially provided a monopoly, fostering high pricing. The loss or imminent expiration of exclusivity opens the market to biosimilar or generic entrants, which often precipitates significant price reductions.

Implication: Already, the market dynamics are shifting toward increased competition, influencing price deterioration trends.

2. Competitive Landscape

The therapeutic category includes several branded agents and generics:

  • Brand Competition: [Brand Name] held a dominant market share, supported by its patent protections and physician loyalty.

  • Generic/Biosimilar Entry: Generics entered the market post-patent expiry in [year]. The degree of substitution varies based on regulatory barriers and formulary preferences.

  • Emerging Alternatives: Novel therapeutics with improved efficacy or safety profiles are in late-stage development, potentially disrupting existing market shares.

Impact: Increased competition contributes to downward pressure on prices but can also expand total market volume through increased physician adoption.

3. Regulatory Environment

FDA regulations influence market access and pricing strategies:

  • Pricing policies: Initiatives targeting inflation reduction or drug affordability may impose caps or negotiation frameworks.

  • Reimbursement policies: Medicare and Medicaid’s formulary decisions and negotiated prices heavily influence retail and hospital pricing.

  • Biosimilar pathways: Regulatory avenues for biosimilar approval impact market entry timelines and competition levels.

4. Healthcare Market Factors

  • Disease prevalence: The incidence of [condition] drives the overall market size. For [condition], prevalence data indicates [e.g., X million]* affected Americans, representing a sizable patient population.

  • Physician adoption: Prescriber preferences, clinical guidelines, and educational outreach influence utilization rates.

  • Patient access: Medicaid expansion, insurance coverage policies, and affordability considerations impact patient uptake.


Pricing Trends and Forecasts

Historical Price Trends

  • Pre-patent expiry: The drug commanded a premium price—approximately $X per unit—driven by exclusivity and high perceived value.

  • Post-patent expiry: Generic entries have precipitated a steep decline, with current average wholesale prices (AWP) ranging between $Y and $Z per unit, representing reductions of X% over recent years.

Future Price Projections

1. Near-term (1-3 years):

  • Anticipate further price erosion, stabilizing at $A$B per unit, driven by increased generic market penetration and potential payer-negotiated discounts.

  • Margins for manufacturers may compress due to intense competition but could be stabilized via value-added services or contract manufacturing.

2. Mid-term (3-5 years):

  • As new competitors or biosimilars consolidate market share, prices could decrease by an additional X%, with projections ranging around $CD per unit.

  • In case of regulatory or legal barriers delaying biosimilar market entry, prices may remain relatively stable or decline at slower rates.

3. Long-term (beyond 5 years):

  • Introduction of novel therapeutics with superior profiles could lead to substantial market share shifts, further reducing traditional drug prices.

  • Market expansion into emerging markets and increased indications may partly offset price erosion locally.

Influencing Factors on Price Projection

  • Patent litigation and legal challenges: Could delay biosimilar entries, prolonging higher price periods.

  • Reimbursement policies: Payer initiatives for formulary restrictions or negotiated discounts influence actual transaction prices more than list prices.

  • Global market forces: International market pricing and regulatory approvals can impact U.S. prices through importation or parallel trade mechanisms.


Strategic Implications for Stakeholders

  • Manufacturers: Should diversify through biosimilar development or value-added indications to mitigate declining revenue streams from traditional formulations.

  • Payers and Policymakers: Encourage price transparency and negotiated discounts to optimize healthcare spending.

  • Healthcare Providers: Embrace cost-effective alternatives, including generics and biosimilars, without compromising patient care quality.


Conclusion

The market for NDC 00069-1001 is characterized by transitional pricing environments driven by patent expirations and increased competition from generics and biosimilars. Pricing is expected to decline steadily over the next five years, with the extent influenced by regulatory, legal, and market factors.

Forecasts suggest a move toward a more competitive landscape, emphasizing the importance of strategic planning for stakeholders to sustain profitability and accessibility.


Key Takeaways

  • Patent expiry significantly accelerates price decline; current and near-term forecasts anticipate prices stabilizing around $A–$B per unit.

  • Competitive pressures from generic/biosimilar entrants dominate future pricing dynamics; market entry timing critically influences trajectory.

  • Reimbursement policies and healthcare reforms shape actual transaction prices, often more than published list prices.

  • Diversification into biosimilar development and expansion into emerging markets offer growth opportunities amid declining traditional product prices.

  • Monitoring regulatory developments and legal challenges remains essential for accurate forecasting and strategic planning.


FAQs

Q1: What is the expected timeline for biosimilar entry for NDC 00069-1001?
Biosimilar approvals typically occur within 8-10 years post-original patent expiration, with actual market entry varying based on regulatory and legal factors.

Q2: How will patent litigation influence future prices?
Prolonged litigation can delay biosimilar entry, maintaining higher prices longer; conversely, swift resolutions may accelerate price reductions.

Q3: Are there geographic differences in pricing for this drug?
Yes, international pricing varies due to local regulations, healthcare systems, and market maturity.

Q4: What strategies can manufacturers employ to maintain revenue?
Diversification into novel indications, biosimilar development, value-based pricing, and expanding into emerging markets are key strategies.

Q5: How do healthcare policies impact the drug’s market prospects?
Policies promoting price transparency, allowing negotiations, and incentivizing biosimilar adoption directly influence market competitiveness and prices.


References

  1. [1] FDA Drug Approvals and Patent Data. U.S. Food and Drug Administration.
  2. [2] IQVIA Institute. The Effect of Patent Expiration on Drug Prices and Market Dynamics. 2022.
  3. [3] Centers for Medicare & Medicaid Services. Reimbursement Policies and Drug Pricing Regulations. 2023.
  4. [4] Market analytics reports from EvaluatePharma and GlobalData. 2022-2023.
  5. [5] International Price Comparison Data. World Health Organization. 2022.

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