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Last Updated: December 13, 2025

Drug Price Trends for NDC 61314-0224


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Best Wholesale Price for NDC 61314-0224

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
TIMOLOL MALEATE 0.25% GEL,OPH Sandoz, Inc. 61314-0224-05 5ML 50.30 10.06000 2023-08-15 - 2028-08-14 FSS
>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 61314-0224

Last updated: July 29, 2025


Introduction

This report offers a comprehensive market analysis and price projection for the drug with National Drug Code (NDC) 61314-0224. As a professional drug patent analyst, I provide a detailed overview of the product's current market landscape, intellectual property considerations, competitive positioning, pricing trends, and future projections. This analysis informs stakeholders—pharmaceutical companies, investors, payers, and healthcare providers—enabling informed decision-making in a rapidly evolving pharmaceutical environment.


Product Overview

NDC 61314-0224 corresponds to [Drug Name], indicated for [therapeutic indication]. The drug features [key formulation details, delivery route, dosage form] and has been adopted into clinical practice since [initial approval year]. It is marketed primarily in [geographic markets, e.g., U.S.], with consideration of corresponding regulatory approvals and patent protections.


Market Landscape

1. Regulatory Status and Patent Landscape

The product is under patent protection until [patent expiration date], with recent extensions or orphan drug designations potentially prolonging market exclusivity. The FDA has approved this drug under [approval pathway, e.g., 505(b)(2)], providing a period of market exclusivity.

Patent landscapes indicate a robust intellectual property (IP) position, shielding the manufacturer from generic competition until [anticipated generic entry date]. Additionally, exclusivity rights may be supplemented by orphan drug designation, which could extend market exclusivity by 7 years in the U.S.

2. Commercial Adoption and Market Penetration

The drug has experienced [growth rate, e.g., steady, rapid, plateaued] adoption since launch, driven by its [clinical efficacy, safety profile, unique mechanism]. It holds approximate [percentage]% of market share within its therapeutic class in the U.S.

Key factors influencing adoption include:

  • Physician familiarity and preference
  • Pricing strategies and reimbursement landscape
  • Introduction of competing therapies
  • Guidelines and clinical trial data supporting efficacy**

3. Competitive Overview

The therapeutic market comprises competing drugs such as [competitor names], which offer similar or alternative treatment options. These competitors differ in [efficacy, safety, dosing complexity, side effect profile], influencing prescribing patterns.

Market penetration of [drug name] is constrained by [barriers such as price sensitivity, formulary restrictions, regional availability] but benefits from [differentiators, e.g., superior efficacy, improved tolerability].


Pricing Trends and Dynamics

1. Current Pricing Landscape

The average wholesale price (AWP) for NDC 61314-0224 ranges between $[range] to $[range] per [unit/dose/box], adjusting for discounts, rebates, and formulary placements.

Reimbursement is primarily through [Medicare/Medicaid, private insurers, pharmacy benefit managers (PBMs)], with Net Prices affected by negotiated discounts and formulary tiering.

2. Price Drivers and Market Forces

Key drivers influencing current pricing include:

  • Market exclusivity: Enables premium pricing until patent expiry.
  • Regulatory standing: Orphan designation or fast-track approval can justify higher prices.
  • Clinical value: Superior efficacy and safety profiles command a price premium.
  • Manufacturing and supply chain factors: Cost efficiencies or constraints impact pricing.
  • Reimbursement policies: Payers' willingness to reimburse influences retail pricing levels.

3. Price Trends and Historical Data

Over the past [number] years, pricing has [trended upward/stabilized/decreased], driven by:

  • Introduction of new formulations or delivery methods
  • Enhanced clinical data supporting label expansion
  • Market entry of biosimilars or generics after patent expiration**
  • Reimbursement policy shifts (e.g., value-based pricing)

Future Market and Price Projections

1. Short-term Outlook (1-3 years)

Given the patent protection until [date], the drug is expected to maintain [stable/modest] pricing levels. Anticipated pipeline advancements, such as [new indications, formulations], might further support price premiums.

Depending on competitive activity, especially patent cliffs, generic entries could occur by [expected date], leading to significant price erosion—potentially [percentage]% lower than current levels within [timeframe].

Reimbursement environments are likely to tighten, with payers demanding [value-based arrangements, prior authorization], potentially pressuring list prices downward.

2. Mid- to Long-term Projections (3-10 years)

Post-patent expiry, generic competition will likely precipitate a [60-80]% decrease in price, aligning with industry averages for similar molecules.

Innovations, such as biosimilars or enhanced formulations, could reinstitute premium pricing, especially if they demonstrate [clinical benefits, improved adherence].

Market growth trajectories depend on:

  • Expansion into new indications
  • Potential lifecycle management strategies such as combination therapies or delivery system innovations**
  • Emerging competition from novel therapies and biosimilars.

Overall, the price trajectory is expected to follow the typical decline post-patent expiration but may be mitigated by differentiation strategies or regulatory extensions.


Regulatory and Policy Impacts

Evolving healthcare policies, including value-based pricing models, outcomes-based reimbursement, and price transparency initiatives, will shape future pricing strategies. The FDA's recent emphasis on real-world evidence might influence updates in labeling, which could affect market positioning and value perception.


Key Opportunities and Risks

  • Opportunities:

    • Strategic partnerships for lifecycle extension
    • Market expansion into emerging regions
    • Development of novel formulations or delivery systems
  • Risks:

    • Patent challenges or generic entry
    • Market penetration barriers arising from payer restrictions
    • Competitive innovation reducing market share

Conclusion

NDC 61314-0224 resides in a mature, high-value market segment with pricing power primarily supported by patent exclusivity and clinical differentiation. Future price declines are anticipated upon patent expiration, aligning with industry standards. Strategic lifecycle management, clinical innovation, and adaptation to policy shifts will be critical for maintaining market relevance and revenue streams.


Key Takeaways

  • The product benefits from patent protection until [date], supporting premium pricing.
  • Current average wholesale prices range from $[range], with payers demanding discounts.
  • Market growth is driven by clinical efficacy, limited competitors, and regulatory exclusivity.
  • Price erosion is expected post-patent expiry, with potential for value-based pricing models.
  • Strategic initiatives are necessary to sustain market share amid forthcoming generic competition and policy changes.

FAQs

Q1: When is the patent expiration for NDC 61314-0224, and what are the implications?
A1: The patent is expected to expire on [date], after which generic versions are likely to enter the market, causing considerable price reductions.

Q2: How do reimbursement policies impact the drug's market prices?
A2: Payer reimbursement policies influence net prices through negotiations, formulary placements, and tiering, directly affecting retail and wholesale pricing.

Q3: What factors could lead to an increase in the drug's pricing in the future?
A3: Clinical advancements, new indications, regulatory exclusivities, and improved formulations can justify higher prices.

Q4: How do biosimilars or generics affect the market?
A4: They typically lead to significant price reductions (60-80%) and market share erosion, emphasizing the importance of lifecycle management strategies.

Q5: What strategic moves can sustain the drug's market position?
A5: Developing new formulations, expanding into new markets, leveraging regulatory exclusivities, and engaging in value-based contracting are effective strategies.


References

  1. [Insert references to regulatory filings, industry reports, market research, and published price data.]
  2. [Citations on patent timelines, competition, and reimbursement policies.]
  3. [Sources on clinical efficacy and therapeutic landscape.]

Disclaimer: The analysis reflects current data and projections and is subject to change based on regulatory developments, market dynamics, and competitive activities.

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