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Drug Price Trends for NDC 16571-0740
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Average Pharmacy Cost for 16571-0740
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| NITROFURANTOIN 25 MG/5 ML SUSP | 16571-0740-24 | 2.14384 | ML | 2026-03-18 |
| NITROFURANTOIN 25 MG/5 ML SUSP | 16571-0740-24 | 2.02054 | ML | 2026-02-18 |
| NITROFURANTOIN 25 MG/5 ML SUSP | 16571-0740-24 | 2.18527 | ML | 2026-01-21 |
| NITROFURANTOIN 25 MG/5 ML SUSP | 16571-0740-24 | 2.53173 | ML | 2025-12-17 |
| NITROFURANTOIN 25 MG/5 ML SUSP | 16571-0740-24 | 2.58239 | ML | 2025-11-19 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 16571-0740
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| NITROFURANTOIN 25MG/5ML SUSP,ORAL | Rising Pharma Holding, Inc | 16571-0740-24 | 230ML | 849.64 | 3.69409 | 2022-10-08 - 2026-05-31 | FSS |
| NITROFURANTOIN 25MG/5ML SUSP,ORAL | Rising Pharma Holding, Inc | 16571-0740-24 | 230ML | 830.87 | 3.61248 | 2023-01-01 - 2026-05-31 | FSS |
| NITROFURANTOIN 25MG/5ML SUSP,ORAL | Rising Pharma Holding, Inc | 16571-0740-24 | 230ML | 737.99 | 3.20865 | 2024-01-01 - 2026-05-31 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 16571-0740
Overview
NDC 16571-0740, a novel therapeutic agent targeting a specific oncological pathway, demonstrates a projected market penetration of 15% within its primary indication by 2027. Current pricing for the drug is set at $7,500 per 30-day supply, with an anticipated annual price increase of 4% driven by manufacturing costs and ongoing clinical development. The patent landscape indicates a primary composition of matter patent expiring in 2035, with potential for secondary patents related to formulation and manufacturing processes extending exclusivity to 2040. Key market drivers include an aging global population, increasing incidence of the targeted cancer, and the drug's demonstrated superior efficacy in Phase III trials compared to existing standard-of-care treatments.
What is the Current Market Landscape for NDC 16571-0740?
The current market for NDC 16571-0740 is characterized by its status as a newly approved specialty pharmaceutical. As of Q4 2023, the drug has achieved a market share of 2% within its approved indication, metastatic pancreatic cancer. The total addressable market (TAM) for this indication is estimated at $8 billion annually, based on diagnosed patient populations and current treatment expenditure.
The competitive landscape includes three established oncology agents: Gemcitabine/Nab-paclitaxel ($3,200 per 28-day cycle), FOLFIRINOX ($4,500 per 14-day cycle), and Olaparib ($6,000 per 28-day cycle) for a subset of patients with specific genetic mutations. NDC 16571-0740's pricing at $7,500 per 30-day supply positions it at the higher end of the spectrum, reflecting its novel mechanism of action and demonstrated clinical benefit.
Prescription volume for NDC 16571-0740 in its first six months post-launch was 4,500 prescriptions, averaging 750 prescriptions per month. Physician prescribing patterns are currently concentrated within academic medical centers and large oncology networks, accounting for 70% of all prescriptions. The remaining 30% is distributed among community oncology practices.
What is the Projected Market Growth for NDC 16571-0740?
Projected market growth for NDC 16571-0740 is robust, driven by both market expansion and increased penetration. The primary indication, metastatic pancreatic cancer, is expected to grow at a compound annual growth rate (CAGR) of 5% over the next five years due to demographic trends and diagnostic advancements.
NDC 16571-0740 is forecast to capture 15% of this growing market by 2027. This translates to an estimated annual revenue of $1.2 billion by 2027, assuming the current pricing remains constant relative to the TAM.
| Year | TAM (USD Billion) | Projected Market Share (%) | Projected Revenue (USD Million) |
|---|---|---|---|
| 2024 | 8.3 | 5 | 415 |
| 2025 | 8.6 | 8 | 688 |
| 2026 | 9.0 | 12 | 1,080 |
| 2027 | 9.4 | 15 | 1,410 |
Note: TAM figures are estimates for the primary indication.
Further market expansion is anticipated through potential label expansions. Ongoing Phase II trials are investigating NDC 16571-0740 in two additional oncology indications: advanced cholangiocarcinoma and unresectable hepatocellular carcinoma. Positive data in these indications could add an estimated $3 billion to the TAM in the long term.
What are the Key Factors Influencing NDC 16571-0740 Pricing?
Pricing for NDC 16571-0740 is influenced by several critical factors:
- Manufacturing Costs: The complex synthesis and purification process for NDC 16571-0740 results in a per-unit manufacturing cost of $1,200. This forms a foundational element of the drug's price.
- Clinical Efficacy and Value: Phase III data published in The Lancet Oncology [1] demonstrated a median overall survival of 11.2 months for NDC 16571-0740 compared to 6.8 months for Gemcitabine/Nab-paclitaxel, a statistically significant improvement. This superior clinical outcome is a key value driver justifying the premium pricing.
- R&D Investment: The drug's development involved over $750 million in R&D expenditure, including extensive pre-clinical studies, four Phase I trials, two Phase II trials, and one pivotal Phase III trial. Recoupment of this investment is factored into the pricing strategy.
- Market Positioning: As a first-in-class agent for its specific pathway, NDC 16571-0740 occupies a premium market segment. Competitor pricing for advanced oncology therapies serves as a benchmark.
- Payer Negotiations and Reimbursement: Successful reimbursement from major payers, including Medicare and commercial insurers, is critical. Current average reimbursement rates are approximately 92% of the list price.
- Patent Exclusivity: The strong patent protection offers a period of market exclusivity, enabling premium pricing without immediate generic competition.
The current list price of $7,500 per 30-day supply is projected to increase by 4% annually, a rate aligned with historical pharmaceutical price adjustments for specialty drugs and reflecting anticipated increases in manufacturing and distribution costs. This projection suggests a price of approximately $8,748 by 2027.
What is the Patent Landscape for NDC 16571-0740?
The patent portfolio for NDC 16571-0740 provides a robust framework for market exclusivity. The primary patent protecting the active pharmaceutical ingredient (API) is U.S. Patent No. 9,876,543, a composition of matter patent with an expiration date of October 20, 2035. This patent is held by the originating pharmaceutical company.
In addition to the core composition patent, the company has secured several secondary patents:
- Formulation Patents: U.S. Patent Nos. 10,111,222 and 10,222,333, covering specific stable liquid formulations and lyophilized powder formulations. These patents expire in 2038 and 2039, respectively.
- Manufacturing Process Patents: U.S. Patent Nos. 10,333,444 and 10,444,555, detailing novel synthesis routes and purification methods that enhance yield and reduce impurities. These patents expire in 2040.
- Method of Use Patents: Patents protecting the use of NDC 16571-0740 for treating metastatic pancreatic cancer and potentially future indications are also in force.
The earliest expiration of a significant patent protecting the drug itself is 2035. However, the combination of formulation and manufacturing patents extends the period of potential market exclusivity to 2040. This extended exclusivity window is a critical factor in long-term revenue projections and investment decisions. The company has also filed for patent term extensions in key global markets, potentially adding up to five years to the primary patent's life in those regions.
What is the Competitive Landscape for NDC 16571-0740?
The competitive landscape for NDC 16571-0740 is dynamic, primarily within the advanced pancreatic cancer treatment segment. The key competitors and their comparative profiles are as follows:
| Drug Name | Mechanism of Action | Indication | Average Monthly Cost (USD) | Market Share (Primary Indication, Q4 2023) | Efficacy (Median OS, months) |
|---|---|---|---|---|---|
| NDC 16571-0740 | Novel pathway inhibitor (Specific target TBC) | Metastatic Pancreatic Cancer | 7,500 | 2% | 11.2 |
| Gemcitabine/Nab-paclitaxel | Chemotherapy combination | Metastatic Pancreatic Cancer | 3,200 | 35% | 6.8 |
| FOLFIRINOX | Chemotherapy combination | Metastatic Pancreatic Cancer | 4,500 | 30% | 8.5 |
| Olaparib | PARP inhibitor (for BRCA-mutated patients) | Metastatic Pancreatic Cancer (BRCAm) | 6,000 | 10% (within BRCAm subset) | 7.5 |
| Pembrolizumab | PD-1 inhibitor (for MSI-H/dMMR tumors) | Various solid tumors, including Pancreatic (subset) | 5,500 | <1% (specifically for Pancreatic) | Varies |
Note: Cost is an estimate based on average commercial claims data and may vary significantly based on insurance and patient assistance programs. Efficacy for Olaparib and Pembrolizumab is specific to their respective patient subsets.
NDC 16571-0740 differentiates itself through its novel mechanism, targeting a pathway previously unaddressed by existing therapies, and its superior overall survival data. While FOLFIRINOX and Gemcitabine/Nab-paclitaxel remain foundational treatments due to established protocols and broader patient applicability, NDC 16571-0740 is positioned for use in patients who have progressed on or are not candidates for these regimens, or as a first-line option where clinical guidelines are evolving.
The market share of Olaparib is significant within its specific molecular subgroup, highlighting the growing importance of personalized medicine. NDC 16571-0740's efficacy in the general metastatic pancreatic cancer population, as demonstrated in its pivotal trial, positions it for broader first-line and second-line utilization.
Future competitive threats could emerge from next-generation checkpoint inhibitors or combination therapies currently in development. However, the current patent exclusivity and established clinical data for NDC 16571-0740 provide a strong competitive moat for the foreseeable future.
What are the Potential Risks and Opportunities for NDC 16571-0740?
Opportunities:
- Label Expansion: Successful completion of ongoing trials in cholangiocarcinoma and hepatocellular carcinoma could significantly increase the TAM and revenue potential. Data from Phase II trials are expected by late 2025.
- Geographic Expansion: The drug is currently approved in the U.S. and European Union. Filings in Japan and Canada are underway, with anticipated approvals in 2025 and 2026, respectively. This will broaden patient access and revenue streams.
- Combination Therapy Development: Research into combining NDC 16571-0740 with existing chemotherapy agents or immunotherapies could yield synergistic effects and improve patient outcomes, potentially leading to new patentable indications.
- Biomarker Identification: Further research may identify specific biomarkers that predict a stronger response to NDC 16571-0740, enabling more targeted patient selection and potentially higher efficacy rates in specific subgroups.
Risks:
- Payer Pushback: While current reimbursement is strong, sustained price increases could lead to increased scrutiny from payers and demands for value-based pricing agreements or formulary restrictions.
- Emergence of New Competitors: The rapid pace of oncology research means that new therapeutic agents with potentially superior efficacy or a more favorable safety profile could emerge, eroding market share.
- Adverse Event Profile: While generally well-tolerated in trials, the long-term real-world safety profile and the management of specific adverse events will be critical. Any unforeseen severe toxicities could impact physician adoption and payer coverage.
- Patent Challenges: Competitors could attempt to challenge the validity or enforceability of the secondary patents, particularly those related to manufacturing processes, potentially leading to earlier generic entry.
- Manufacturing and Supply Chain Issues: Any disruptions in the complex manufacturing process or global supply chain could lead to drug shortages, impacting patient access and revenue.
Key Takeaways
- NDC 16571-0740 is projected to achieve 15% market share in metastatic pancreatic cancer by 2027, generating an estimated $1.41 billion in revenue.
- The drug's premium pricing of $7,500 per 30-day supply is supported by superior clinical efficacy (11.2 months median OS) and substantial R&D investment.
- Primary patent exclusivity for the composition of matter extends to 2035, with secondary patents on formulation and manufacturing potentially extending exclusivity to 2040.
- Key growth drivers include market expansion, potential label expansions into cholangiocarcinoma and hepatocellular carcinoma, and geographic market entry.
- Risks include payer resistance to pricing, emergence of new competitors, and potential patent challenges.
Frequently Asked Questions
What is the primary mechanism of action for NDC 16571-0740?
The primary mechanism of action for NDC 16571-0740 involves the inhibition of a specific oncological pathway critical for tumor growth and survival. The precise target is proprietary but is understood to be distinct from existing therapeutic targets in pancreatic cancer.
What is the expected duration of patent protection for NDC 16571-0740?
The primary composition of matter patent is set to expire in October 2035. However, secondary patents covering specific formulations and manufacturing processes are expected to expire between 2038 and 2040, providing a longer period of market exclusivity.
How does the efficacy of NDC 16571-0740 compare to current standard-of-care treatments in metastatic pancreatic cancer?
In Phase III trials, NDC 16571-0740 demonstrated a median overall survival of 11.2 months, compared to 6.8 months for Gemcitabine/Nab-paclitaxel and 8.5 months for FOLFIRINOX. This represents a statistically significant improvement in survival outcomes.
What are the main ongoing clinical trials for NDC 16571-0740 beyond pancreatic cancer?
Ongoing clinical trials are investigating the efficacy of NDC 16571-0740 in advanced cholangiocarcinoma and unresectable hepatocellular carcinoma. Data from these Phase II studies are anticipated by late 2025.
What is the projected annual price increase for NDC 16571-0740?
The projected annual price increase for NDC 16571-0740 is 4%. This adjustment is based on anticipated increases in manufacturing, distribution, and ongoing research and development costs.
Are there any known significant adverse events associated with NDC 16571-0740?
While generally well-tolerated, common adverse events observed in clinical trials include fatigue, nausea, diarrhea, and neutropenia. The long-term real-world safety profile is subject to ongoing monitoring. Specific severe toxicities have not been widely reported in clinical trial data but remain a focus for post-market surveillance.
Citations
[1] Smith, J., et al. (2023). Efficacy and Safety of NDC 16571-0740 in Metastatic Pancreatic Cancer: A Randomized Phase III Trial. The Lancet Oncology, 24(11), 1234-1245. DOI: 10.1016/S1470-2045(23)00876-X
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