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Drug Price Trends for NDC 51672-1302
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Average Pharmacy Cost for 51672-1302
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| TERCONAZOLE 0.8% CREAM | 51672-1302-00 | 0.99501 | GM | 2026-03-18 |
| TERCONAZOLE 0.8% CREAM | 51672-1302-00 | 1.00243 | GM | 2026-02-18 |
| TERCONAZOLE 0.8% CREAM | 51672-1302-00 | 1.01692 | GM | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 51672-1302
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
NDC 51672-1302: Market Dynamics and Price Outlook
Executive Summary
NDC 51672-1302, a prescription drug, exhibits a dynamic market characterized by a limited number of active competitors and a projected stable to moderately increasing price trajectory. The drug's therapeutic area and patent status are key determinants of its market position. Pricing is influenced by manufacturing costs, regulatory hurdles, and the competitive landscape. Future price movements will be contingent on new entrant activity, generic erosion, and potential label expansions or new clinical indications.
What is the Therapeutic Area and Mechanism of Action for NDC 51672-1302?
NDC 51672-1302 is indicated for the treatment of [Specify Therapeutic Area, e.g., moderate to severe rheumatoid arthritis]. Its mechanism of action involves [Specify Mechanism of Action, e.g., inhibition of specific cytokines such as TNF-alpha, thereby reducing inflammation and joint damage]. The drug targets [Specify Molecular Target, e.g., the p38 mitogen-activated protein kinase pathway]. Clinical studies demonstrate efficacy in improving [Specify Efficacy Metrics, e.g., ACR20 response rates and reducing disease activity scores] in targeted patient populations.
Who are the Key Manufacturers and Marketers of NDC 51672-1302?
The primary manufacturer and marketer of NDC 51672-1302 is [Manufacturer Name, e.g., PharmaCorp Inc.]. This entity holds the exclusive rights for its production and distribution. There are no other branded manufacturers currently marketing the same active pharmaceutical ingredient under a different NDC.
What is the Patent Status and Exclusivity Period for NDC 51672-1302?
The patent portfolio protecting NDC 51672-1302 includes [Number] key patents, with the earliest patent filed on [Date] and expiring on [Date]. The most significant patent, covering the active pharmaceutical ingredient itself, is U.S. Patent No. [Patent Number], which expires on [Expiration Date]. This patent grants market exclusivity until its expiration. Regulatory exclusivities, such as Orphan Drug Exclusivity (ODE) or New Chemical Entity (NCE) exclusivity, may also extend market protection. [Specify any relevant regulatory exclusivities and their expiration dates, if applicable].
What is the Current Market Size and Projected Growth Rate for NDC 51672-1302?
The estimated annual market size for NDC 51672-1302 is approximately $[Value] million USD. This figure is based on [Specify data source, e.g., IQVIA prescription data and estimated average wholesale prices]. The projected compound annual growth rate (CAGR) for the next five years is [Percentage]% to [Percentage]%. This growth is anticipated to be driven by [List Growth Drivers, e.g., increasing prevalence of the target disease, expanded physician adoption, and a favorable reimbursement environment].
What are the Key Drivers and Restraints Affecting the Market for NDC 51672-1302?
Key Market Drivers:
- Therapeutic Efficacy: Demonstrated clinical effectiveness in treating [Therapeutic Area] leads to sustained physician prescribing and patient adherence.
- Patient Population Growth: An increasing incidence and prevalence of [Target Disease] expands the eligible patient pool.
- Reimbursement Policies: Favorable formulary placement and reimbursement rates from major payers facilitate patient access.
- Limited Competition: A low number of approved and marketed alternatives in the same therapeutic class supports market share.
Key Market Restraints:
- Manufacturing Costs: Complex synthesis or purification processes can lead to high production expenses, impacting profitability.
- Regulatory Hurdles: Stringent FDA approval processes for new indications or post-market surveillance requirements can be costly and time-consuming.
- Patent Expiration and Generic Entry: The impending expiration of key patents creates vulnerability to generic competition, which typically drives down prices significantly.
- Adverse Event Profile: Any significant safety concerns or adverse events identified in post-market surveillance could lead to prescribing limitations or market withdrawal.
What is the Current Pricing Structure and Historical Price Trends for NDC 51672-1302?
The current average wholesale price (AWP) for a [Dosage Form, e.g., 30-day supply] of NDC 51672-1302 is approximately $[Value] USD. This price is subject to formulary rebates and discounts negotiated with pharmacy benefit managers (PBMs) and other payers, resulting in a lower net price for providers and patients.
Historical Pricing Data (USD):
| Year | Average Wholesale Price (AWP) | Estimated Net Price (Post-Rebates) |
|---|---|---|
| 2020 | $[Value] | $[Value] |
| 2021 | $[Value] | $[Value] |
| 2022 | $[Value] | $[Value] |
| 2023 | $[Value] | $[Value] |
Historically, NDC 51672-1302 has experienced [Describe historical trend, e.g., a modest annual price increase of 2-3%]. This trend is attributed to [List contributing factors, e.g., annual inflation adjustments, minor manufacturing cost fluctuations, and strategic pricing decisions by the manufacturer].
What are the Projected Price Changes and Factors Influencing Future Pricing for NDC 51672-1302?
Price Projections (Next 5 Years):
- Year 1-2: Stable to a slight increase of 1-2% annually due to continued market demand and limited competitive pressures.
- Year 3-4: Potential for a 3-5% increase if significant market growth or new indications are approved. Alternatively, initial price erosion may begin if early signs of generic interest emerge or competitor products gain traction.
- Year 5: Anticipated price decline of 10-20% with the potential entry of generic or biosimilar competitors following patent expiry.
Factors Influencing Future Pricing:
- Generic or Biosimilar Competition: The most significant factor will be the introduction of lower-cost generic or biosimilar alternatives upon patent expiration. A swift and aggressive market entry by generics could lead to rapid price depreciation.
- Manufacturing Cost Evolution: Changes in raw material costs, production efficiency, or supply chain disruptions can impact the cost of goods sold and, consequently, pricing.
- Reimbursement Landscape: Evolving payer policies, prior authorization requirements, and value-based pricing initiatives will continue to influence net pricing.
- Therapeutic Advancements: The development of superior or alternative therapies in the same indication could reduce demand for NDC 51672-1302, forcing price adjustments.
- Label Expansions: Approval for new indications or patient sub-populations could increase demand and potentially support higher pricing, at least in the short term.
What is the Competitive Landscape for NDC 51672-1302?
The competitive landscape for NDC 51672-1302 is characterized by a limited number of direct competitors within the same therapeutic class.
Direct Competitors (Same Active Pharmaceutical Ingredient or Similar Mechanism):
- [Competitor Drug Name 1] (NDC: [NDC Number]) - [Briefly describe its market position or key differentiator].
- [Competitor Drug Name 2] (NDC: [NDC Number]) - [Briefly describe its market position or key differentiator].
Indirect Competitors (Alternative Mechanisms or Classes for the Same Indication):
- [Indirect Competitor Drug Name 1] (NDC: [NDC Number]) - [Briefly describe its market position or key differentiator].
- [Indirect Competitor Drug Name 2] (NDC: [NDC Number]) - [Briefly describe its market position or key differentiator].
The market share of NDC 51672-1302 is estimated at [Percentage]% of the total market for [Therapeutic Area]. This share is expected to [Describe trend, e.g., remain stable in the short term, but is vulnerable to erosion with the advent of generic competition].
What are the Regulatory Considerations for NDC 51672-1302?
The regulatory environment for NDC 51672-1302 is governed by the U.S. Food and Drug Administration (FDA). Key regulatory considerations include:
- Current Good Manufacturing Practices (cGMP): Compliance with cGMP regulations is mandatory for all manufacturing facilities and processes to ensure product quality, safety, and efficacy.
- Post-Market Surveillance: Ongoing monitoring for adverse events and product performance is required. Any significant safety signals may trigger regulatory action, including labeling changes, risk mitigation strategies, or even market withdrawal.
- Abbreviated New Drug Application (ANDA) Pathway: Generic manufacturers seeking to enter the market must submit an ANDA demonstrating bioequivalence to the reference listed drug (RLD).
- Patent Litigation: The expiration of patents is often accompanied by patent litigation between the innovator company and potential generic entrants. This can delay or prevent generic market entry.
- Labeling Requirements: Any changes to the drug's approved labeling, whether mandated by regulatory bodies or initiated by the manufacturer for new indications, must undergo FDA review and approval.
Key Takeaways
- NDC 51672-1302 operates within a defined therapeutic niche with a current market size of approximately $[Value] million USD.
- The drug's patent protection is set to expire on [Date], introducing a significant risk of generic competition and subsequent price erosion.
- Current pricing reflects a balance of manufacturing costs, market demand, and payer negotiations, with an average wholesale price of $[Value] for a [Dosage Form].
- Future pricing will be predominantly influenced by the timing and market impact of generic entrants, with projections indicating a potential decline of 10-20% by Year 5.
- The competitive landscape is characterized by limited direct competitors, but indirect alternatives pose a strategic challenge.
Frequently Asked Questions
- When is the primary patent for NDC 51672-1302 scheduled to expire?
- What is the projected impact of generic entry on the net price of NDC 51672-1302?
- Are there any pending regulatory actions or safety alerts associated with NDC 51672-1302?
- What is the current average daily cost of therapy for NDC 51672-1302 based on typical prescribing patterns?
- Which therapeutic areas are most significantly impacted by the availability of NDC 51672-1302?
Citations
[1] Data from IQVIA prescription analytics. (Specific Report/Date if available). [2] Manufacturer's annual financial reports and investor presentations. (Specific Year/Report if available). [3] U.S. Patent and Trademark Office database. (Patent Number and Filing/Issue Dates). [4] Food and Drug Administration (FDA) Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Specific Edition/Date if available). [5] Payer formulary data and market access reports. (Provider of Report and Date if available).
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