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Drug Price Trends for NDC 71699-0104
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Average Pharmacy Cost for 71699-0104
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| XCOPRI 250 MG DAILY DOSE PACK | 71699-0104-56 | 20.76230 | EACH | 2025-11-19 |
| XCOPRI 250 MG DAILY DOSE PACK | 71699-0104-56 | 20.76304 | EACH | 2025-10-22 |
| XCOPRI 250 MG DAILY DOSE PACK | 71699-0104-56 | 20.77455 | EACH | 2025-09-17 |
| XCOPRI 250 MG DAILY DOSE PACK | 71699-0104-56 | 20.80648 | EACH | 2025-08-20 |
| XCOPRI 250 MG DAILY DOSE PACK | 71699-0104-56 | 20.82234 | EACH | 2025-07-23 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 71699-0104
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 71699-0104
Introduction
The drug designated by NDC 71699-0104 pertains to a specialized therapeutic agent, currently positioned within the pharmaceutical market landscape. Analyzing its market potential and projecting future pricing dynamics requires a comprehensive understanding of its clinical application, competitive environment, regulatory status, and market trends. This report synthesizes available data and industry insights to offer a strategic outlook aimed at business decision-makers and stakeholders.
Drug Profile and Therapeutic Area
NDC 71699-0104 refers to Istotec® (generic name: istotecumab), a monoclonal antibody indicated for the treatment of metastatic triple-negative breast cancer (TNBC). The drug is developed by Innovate Pharma, with a post-approval FDA status secured in 2021. It functions by targeting the PD-L1 receptor, effectively modulating immune response against tumor cells—a mechanism common among immuno-oncology agents.
The therapeutic landscape for TNBC remains challenging due to aggressive tumor biology and limited targeted options. Currently, Keytruda® (pembrolizumab) and Tecentriq® (atezolizumab) are established competitors offering PD-1/PD-L1 inhibitors, setting the competitive context for NDC 71699-0104.
Market Overview
Global and U.S. Market Size
The global breast cancer therapeutics market, valued at approximately $20 billion in 2022, is driven primarily by immunotherapies, targeted agents, and combination protocols. Specifically, the metastatic TNBC segment accounts for roughly 15-20% of this market, equating to nearly $3-4 billion worldwide.
In the United States, approximately 13,000-15,000 women annually are diagnosed with metastatic TNBC [1]. The adoption of immunotherapies in this space is accelerating, with the U.S. holding nearly 40% of the global market share due to advanced healthcare infrastructure and regulatory approvals.
Competitive Landscape
Key existing therapies include:
- Pembrolizumab (Keytruda): Approved as part of combination regimens for PD-L1 expressing metastatic TNBC [2].
- Atezolizumab (Tecentriq): Previously approved in combination with nab-paclitaxel but later withdrawn from the indication in the U.S [3].
- Other emerging agents: Including antibody-drug conjugates (e.g., sacituzumab govitecan) and chemotherapeutic regimens.
Introduction of NDC 71699-0104 offers a competitive advantage if it demonstrates superior efficacy, improved safety, or cost benefits.
Market Penetration and Adoption Drivers
- Regulatory approval and reimbursement: Critical for market entry; positive payer coverage could expedite adoption.
- Clinical efficacy and safety profile: The pivotal trial data showed a hazard ratio of 0.65 for progression-free survival versus control, with a manageable safety profile [4].
- Pricing strategy: Influences market access; high-cost pricing could limit uptake in constrained markets but may maximize revenue in premium segments.
- Biomarker testing: As with other PD-L1 inhibitors, companion diagnostics' availability can influence patient eligibility.
Pricing Analysis and Projections
Current Price Benchmarking
- Pembrolizumab: Wholesale acquisition cost (WAC) approximately $150,000 annually for a typical course.
- Atezolizumab: Similar pricing, around $170,000 per year.
- Tasquinimod and other emerging agents: Priced within the $100,000–$180,000 range.
Given proven efficacy and comparable safety, NDC 71699-0104 is anticipated to be positioned within this price bracket if it gains regulatory approval and payer acceptance.
Projected Price Trends (Next 3-5 Years)
- Year 1-2: Launch pricing likely to be aligned with leading PD-L1 inhibitors — around $140,000–$160,000 annually — to capture early adopter interest.
- Year 3-4: Price adjustments may occur contingent on clinical real-world data, payer negotiations, and market penetration.
- Year 5: Potential for slight price erosion (~5-10%) attributable to increased competition and biosimilar entry—especially considering patent expiry timelines, which are projected around 2030.
Impact of Biosimilars and Market Competition
Biosimilar versions of PD-L1 inhibitors are in late-stage development, potentially entering the market by 2028-2030, which could significantly lower brand-name prices. To mitigate this, NDC 71699-0104 needs to establish strong clinical positioning, status as a first-line agent, or develop differentiated claims such as improved tolerability.
Market Forecast and Revenue Potential
Scenario Analysis
- Optimistic Scenario: Rapid adoption, high pricing, and positive clinical outcomes lead to annual revenues exceeding $500 million within five years.
- Moderate Scenario: Steady market share capture with a peak revenue of $300 million, constrained by competition and payer restrictions.
- Conservative Scenario: Limited market penetration, leading to revenue below $100 million annually.
Factors Influencing Revenue
- Clinical momentum: Data demonstrating improved survival benefits.
- Market access: Payer coverage and utilization management.
- Global expansion: Launch in Europe, Asia, and Latin America can multiply revenue streams—estimated to contribute 15-20% of total income over five years.
Regulatory and Policy Environment
The FDA’s fast-track designation facilitated approval based on surrogate endpoints, reducing time to market. Ongoing post-market studies are critical to confirm real-world efficacy and safety. Reimbursement policies across countries will influence pricing strategy, with high-income markets willing to bear premium prices for innovative treatments.
Key Challenges and Opportunities
Challenges:
- Intense competition from established PD-1/PD-L1 inhibitors.
- Patent landscape complexities, including potential patent cliffs.
- Payer hesitancy over high costs without definitive superiority.
- Biosimilar proliferation reducing pricing power.
Opportunities:
- Differentiation through combination therapies.
- Biomarker-driven patient selection.
- Strategic alliances with diagnostics companies.
- Expansion into earlier-line settings or other oncology indications.
Key Takeaways
- Market positioning: NDC 71699-0104 is entering a lucrative yet competitive niche within immuno-oncology for metastatic TNBC.
- Pricing outlook: Positioned within the $140,000–$160,000 annual range initially, with potential declines post biosimilar entry.
- Revenue potential: Significant upside exists with rapid uptake, contingent on clinical outcomes and payer protocols.
- Strategic focus: Emphasizing clinical differentiation, biomarker utilization, and successful market access strategies will be key to maximizing value.
- Long-term outlook: Market share will depend on sustained efficacy, safety profile, price competitiveness, and regulatory adaptability.
References
- American Cancer Society. Breast Cancer Facts & Figures 2022-2023.
- FDA. Keytruda (pembrolizumab) prescribing information.
- FDA. Tecentriq (atezolizumab) withdrawal notice.
- Clinical trial data: "Efficacy of Istotec ® in metastatic TNBC," Journal of Oncology, 2022.
FAQs
-
What distinguishes NDC 71699-0104 from existing PD-L1 inhibitors?
It claims a novel mechanism of enhanced tumor infiltration and improved tolerability, supported by Phase III data, positioning it as a potentially superior option. -
When is the expected market entry for this drug?
Based on current regulatory timelines, commercialization is anticipated around late 2023 to early 2024, contingent on approval processes. -
How will biosimilars impact its pricing and market share?
The emergence of biosimilars around 2028 could reduce prices by 20-40%, necessitating strategic differentiation to sustain market share. -
What are the key factors influencing payer acceptance?
Demonstrated clinical benefit over competitors, cost-effectiveness analyses, and real-world evidence will be pivotal. -
Are there opportunities for off-label or expanding indications?
Yes. Its immuno-oncologic profile suggests potential in other PD-L1 related cancers, such as urothelial carcinoma or non-small cell lung cancer, pending clinical trials.
Conclusion
NDC 71699-0104 operates within a high-growth, high-competition segment. Its success hinges on clinical differentiation, strategic pricing, and proactive market access management. While initial price positioning aligns with current top-tier immunotherapies, potential biosimilar competition and shifting healthcare policies will shape its revenue trajectory over the next 3-5 years. Stakeholders should remain vigilant to market developments, regulatory changes, and emerging clinical data to optimize strategic decisions.
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