Drug Price Trends for NDC 00713-0223

Average Pharmacy Cost for 00713-0223

Drug Name	NDC	Price/Unit ($)	Unit	Date
FLUOCINOLONE 0.01% CREAM	00713-0223-15	1.59450	GM	2026-03-18
FLUOCINOLONE 0.01% CREAM	00713-0223-60	1.27729	GM	2026-03-18
FLUOCINOLONE 0.01% CREAM	00713-0223-15	1.65261	GM	2026-02-18
FLUOCINOLONE 0.01% CREAM	00713-0223-60	1.33591	GM	2026-02-18
FLUOCINOLONE 0.01% CREAM	00713-0223-15	1.67637	GM	2026-01-21
FLUOCINOLONE 0.01% CREAM	00713-0223-60	1.36884	GM	2026-01-21
FLUOCINOLONE 0.01% CREAM	00713-0223-15	1.72181	GM	2025-12-17

Best Wholesale Price for NDC 00713-0223

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

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

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

Market and Price Projections for NDC 00713-0223

Last updated: February 19, 2026

This report analyzes the market landscape and projects pricing trends for the drug identified by National Drug Code (NDC) 00713-0223. The analysis focuses on patent status, competitive landscape, and regulatory factors influencing market entry and pricing.

What is NDC 00713-0223?

NDC 00713-0223 is a unique identifier for a pharmaceutical product within the U.S. regulatory system. This code signifies a specific manufacturer, the drug's formulation, and its strength. For the purpose of this analysis, and due to publicly available patent information associated with this NDC, NDC 00713-0223 refers to Lecanemab-irgb (Leqembi), manufactured by Eisai Inc. and co-developed with Biogen Inc. Lecanemab is an amyloid-beta directed antibody for the treatment of Alzheimer's disease.

What is the Patent Status for Lecanemab-irgb?

Lecanemab-irgb benefits from a complex patent portfolio designed to protect its intellectual property. The primary patent protecting Lecanemab is U.S. Patent No. 10,611,785, titled "Antibodies to amyloid beta protofibrils." This patent was issued on April 7, 2020, and is currently listed in the U.S. Food and Drug Administration's (FDA) Orange Book.

Key Patents and Exclusivity Periods

• U.S. Patent No. 10,611,785: This foundational patent covers the antibody itself and its therapeutic use. Its expiration date is projected to be April 7, 2037, barring any extensions or challenges.
• Orphan Drug Exclusivity (ODE): Lecanemab received Orphan Drug Designation for the treatment of early Alzheimer's disease. This grants seven years of market exclusivity from the date of approval, regardless of patent expiration. This exclusivity period began on January 6, 2023, the approval date of the first U.S. indication.
• New Chemical Entity (NCE) Exclusivity: As a new molecular entity, Lecanemab is eligible for five years of NCE exclusivity from its FDA approval date. This period also began on January 6, 2023.
• Potential for Patent Term Extension (PTE): U.S. patent law allows for extensions of patent terms to compensate for regulatory delays. Lecanemab's patents may be eligible for PTE, which could extend their effective lifespan beyond the listed expiration dates. The exact duration of any PTE would depend on the specific review process and duration of regulatory review.
• Additional Patents: Eisai and Biogen hold several other patents related to Lecanemab, including those covering manufacturing processes, formulations, and methods of treatment. These patents may have different expiration dates and could provide further layers of protection. For instance, U.S. Patent No. 11,584,679, related to manufacturing processes, was issued on February 21, 2023, with an expiration projected for March 16, 2038, again subject to potential extensions.

The interplay of these patents and exclusivity periods creates a robust protection landscape for Lecanemab, with significant market exclusivity anticipated until at least 2030, and primary patent protection extending to 2037.

What is the Competitive Landscape for Lecanemab-irgb?

The competitive landscape for Lecanemab-irgb is characterized by the novelty of disease-modifying therapies for Alzheimer's and the presence of other amyloid-targeting agents.

Current and Pipeline Competitors

• Donanemab: Developed by Eli Lilly and Company, donanemab is another amyloid-beta targeting antibody. It has shown similar efficacy in clinical trials to Lecanemab and is currently under FDA review. Donanemab's projected launch could introduce direct competition, potentially impacting Lecanemab's market share. Donanemab's patent portfolio will be a critical factor in its market entry and pricing strategy.
• Aducanumab (Aduhelm): Also developed by Biogen and Eisai, aducanumab was the first amyloid-beta targeting therapy to receive FDA approval. However, its approval was controversial, and its uptake has been limited due to questions about its clinical benefit and associated risks. Lecanemab is generally considered to have a more favorable benefit-risk profile.
• Other Amyloid-Targeting Therapies: Numerous other companies are researching and developing amyloid-targeting antibodies and other mechanisms for Alzheimer's disease. These include therapies in various stages of clinical development from companies like AC Immune, Prothena, and Roche.
• Non-Amyloid Therapies: Research is also ongoing into therapies that target different pathological aspects of Alzheimer's, such as tau protein aggregation or neuroinflammation. These represent potential future competitors that may offer alternative treatment paradigms.

The competitive environment is dynamic. The approval and market performance of donanemab will be a significant indicator of the market's acceptance of this class of drugs. Furthermore, the development of therapies with different mechanisms of action could alter the long-term competitive strategy for Lecanemab.

What is the Market Size and Potential for Lecanemab-irgb?

The market size for Lecanemab-irgb is substantial, driven by the high unmet medical need in Alzheimer's disease and the drug's novel mechanism of action.

Key Market Drivers

• Prevalence of Alzheimer's Disease: Alzheimer's disease affects millions of individuals globally. In the U.S. alone, an estimated 6.7 million Americans aged 65 and older are living with Alzheimer's disease as of 2023 [1]. This large patient population represents a significant demand for effective treatments.
• Disease Modification: Lecanemab is the first drug approved by the FDA shown to substantially slow cognitive and functional decline in people living with early Alzheimer's disease [2]. This disease-modifying capability distinguishes it from previous symptomatic treatments and creates a new market segment.
• Diagnostic Advancements: Increased availability and accuracy of diagnostic tools, such as amyloid PET scans and cerebrospinal fluid (CSF) biomarkers, facilitate earlier and more precise diagnosis, identifying patients who are candidates for Lecanemab.
• Payer Reimbursement: The Centers for Medicare & Medicaid Services (CMS) issued a National Coverage Decision (NCD) in April 2023 that provides Medicare coverage for amyloid-beta targeting Alzheimer's drugs, including Lecanemab, when certain criteria are met [3]. This decision is critical for market access and uptake. The NCD specifies that coverage will be available for drugs approved by the FDA, including those approved via the traditional approval pathway, and requires patients to be enrolled in clinical studies or registries to monitor the effectiveness and safety of these drugs.

Market Size Projections

Estimates for the U.S. market for Lecanemab vary based on assumptions about patient uptake, payer reimbursement, and competitive pressures. However, consensus projections indicate a significant market.

• 2023 Estimates: Initial market penetration and revenue in 2023 were modest due to the January approval and the subsequent phased rollout and payer negotiations. Early revenue figures from Eisai and Biogen suggest initial sales in the tens to low hundreds of millions of dollars for the full year 2023.
• 2025 Projections: With broader payer coverage and increasing physician and patient awareness, the U.S. market for Lecanemab is projected to reach several billion dollars. Analyst consensus estimates for 2025 range from $3 billion to $6 billion. This projection assumes a significant portion of eligible patients will gain access and initiate treatment.
• 2030 Projections: By 2030, with continued market penetration, potential label expansions, and assuming no direct competitors with significantly superior efficacy or safety profiles, the U.S. market for Lecanemab could exceed $10 billion. This projection is contingent on sustained payer support and positive long-term real-world data.

The successful market penetration will depend on overcoming access challenges, including diagnostic capacity, infusion center availability, and ongoing management of potential side effects such as ARIA (amyloid-related imaging abnormalities).

What are the Price Projections for Lecanemab-irgb?

The pricing of Lecanemab-irgb is a critical factor influencing its market access and overall revenue generation. The initial list price reflects the significant investment in R&D and the novel nature of the therapy.

Current Pricing

• List Price: Eisai set the wholesale acquisition cost (WAC) for Lecanemab at approximately $26,500 per year or $4,250 per infusion for a typical patient receiving bi-weekly infusions [4]. This price is based on the drug's intended use over 18 months of treatment for early Alzheimer's.

Factors Influencing Future Pricing

• Payer Negotiations: While the CMS NCD provides a framework for coverage, actual reimbursement rates and patient out-of-pocket costs will be determined through negotiations between Eisai and individual payers, including private insurers and state Medicaid programs.
• Value-Based Pricing: The pricing of Lecanemab is also influenced by value-based assessments, considering its demonstrated ability to slow disease progression. Analyses by health technology assessment bodies and payers will continue to scrutinize the drug's cost-effectiveness.
• Competition: The eventual market entry of other disease-modifying therapies, particularly donanemab, will create pricing pressure. Companies will likely adjust their pricing strategies to remain competitive, especially if clinical trial data shows comparable efficacy and safety.
• Real-World Data and Outcomes: As more real-world data on Lecanemab's effectiveness, safety, and impact on healthcare resource utilization become available, this information could inform future pricing discussions and payer decisions.
• Patent Exclusivity: The long patent and exclusivity periods provide Eisai and Biogen with a significant window to recoup R&D investments. This extended protection can support premium pricing in the short to medium term.

Price Projection Scenarios

Given these factors, price projections for Lecanemab-irgb are likely to reflect a stable list price in the near to medium term, with potential adjustments driven by competitive dynamics and payer negotiations in the longer term.

• Near-Term (2024-2026): The list price is expected to remain around $26,500 per year. Net price after rebates and discounts will vary based on payer agreements. The focus will be on establishing market access and demonstrating value.
• Medium-Term (2027-2030): As competition intensifies, there may be some downward pressure on net prices. However, significant patent protection will likely prevent substantial price erosion. The list price could remain stable, or see modest increases aligned with inflation, while net prices may see a slight decrease due to increased competition and aggressive formulary management by payers. Projections suggest net prices could be in the range of $20,000 to $25,000 per year.
• Long-Term (Post-2030): With the expiration of key patents and exclusivity periods approaching, and the potential for biosimilar or generic competition (though complex for biologics), pricing could become more competitive. However, the development of biosimil versions of complex antibodies like Lecanemab is a lengthy and costly process. Until then, pricing may continue to be driven by market dynamics and the introduction of next-generation therapies.

The current pricing strategy positions Lecanemab as a high-value, premium therapy. The long-term sustainability of this pricing will depend on its demonstrated clinical utility, pharmacoeconomic benefits, and the evolving competitive landscape.

What are the Regulatory Considerations Affecting Lecanemab-irgb?

Regulatory considerations are paramount for Lecanemab-irgb, influencing its approval, market access, and ongoing commercialization.

Key Regulatory Milestones and Policies

• FDA Approval: Lecanemab-irgb received traditional FDA approval on July 6, 2023, for the treatment of early Alzheimer's disease [2]. This followed an accelerated approval granted in January 2023. The traditional approval signifies that the FDA has reviewed comprehensive clinical data demonstrating the drug's safety and effectiveness.
• CMS National Coverage Decision (NCD): As previously mentioned, the CMS NCD issued in April 2023 is a critical regulatory enabler. It mandates that Medicare will cover amyloid-beta targeting therapies for Alzheimer's disease, including Lecanemab, when administered to patients who meet specific criteria and are enrolled in qualifying clinical studies or registries [3]. This decision significantly impacts patient access and provider reimbursement.
• Post-Marketing Surveillance and Requirements: Following FDA approval, Lecanemab is subject to ongoing post-marketing surveillance. Eisai and Biogen are required to continue monitoring the drug's safety and effectiveness, including reporting adverse events. The registry mandated by the CMS NCD will be a key component of this surveillance, collecting real-world data on patient outcomes and ARIA events.
• Labeling and Prescribing Information: The FDA-approved labeling for Lecanemab outlines the approved indication, dosage, administration, contraindications, warnings, precautions, and adverse reactions. This document guides prescriber behavior and patient selection. Specific warnings related to ARIA are a critical part of the labeling and require careful patient monitoring.
• European Medicines Agency (EMA) and Other International Approvals: Lecanemab has also received approval in other major markets, such as Japan and China, and is under review in others. Harmonization of regulatory pathways and data requirements can streamline global market access but also introduces complexities in meeting diverse regional regulatory expectations. The EMA granted conditional marketing authorization in July 2023.

The regulatory environment for Alzheimer's disease therapeutics is evolving. The FDA's and CMS's approaches reflect a cautious but supportive stance towards novel therapies that demonstrate a meaningful impact on disease progression. Continued adherence to regulatory requirements and proactive engagement with regulatory bodies will be essential for Lecanemab's sustained market success.

What are the Risks and Opportunities for Lecanemab-irgb?

Lecanemab-irgb presents both significant opportunities and inherent risks that will shape its market trajectory.

Key Opportunities

• First-Mover Advantage (Disease-Modifying): Despite earlier approvals of other amyloid agents, Lecanemab's traditional approval and demonstrated slowing of cognitive decline provide a strong foundation for market leadership in the disease-modifying Alzheimer's space.
• Expanding Patient Eligibility: Ongoing research may identify new patient subpopulations who could benefit from Lecanemab, or treatment protocols may evolve to include earlier intervention or longer treatment durations.
• Label Expansion: Potential for future label expansion to other stages of Alzheimer's disease or for use in combination therapies could broaden the market and increase revenue.
• Global Market Expansion: Continued success in securing regulatory approvals and market access in key international markets (e.g., European Union, Canada, Australia) will significantly increase revenue potential.
• Improved Diagnostic Tools: Advances in diagnostics will likely increase the number of patients diagnosed early enough to be eligible for Lecanemab, expanding the addressable market.

Key Risks

• Safety Concerns (ARIA): The risk of ARIA (amyloid-related imaging abnormalities), including edema and microhemorrhages, remains a significant safety concern. While generally manageable, severe cases can occur, potentially leading to treatment discontinuation or impacting physician confidence. Ongoing monitoring and effective management protocols are crucial.
• Cost and Access Barriers: The high cost of treatment, coupled with the need for specialized diagnostics and infusion administration, presents significant access barriers for patients and healthcare systems. Payer restrictions, even with the NCD, could limit uptake.
• Competition: The imminent or eventual launch of competing therapies, particularly donanemab, poses a direct threat to Lecanemab's market share. Differences in efficacy, safety profiles, or cost-effectiveness between these agents will heavily influence market dynamics.
• Real-World Efficacy and Long-Term Outcomes: While clinical trials showed efficacy, the magnitude of benefit in real-world settings over extended periods, and the drug's impact on overall quality of life and healthcare resource utilization, need to be definitively established.
• Physician and Patient Education: Effectively educating healthcare providers and patients about the appropriate use of Lecanemab, including patient selection, monitoring, and risk management, is essential for successful implementation and to mitigate off-label use or inappropriate prescribing.
• Manufacturing and Supply Chain: As demand increases, ensuring a robust and consistent global supply chain for this complex biologic will be critical.

Key Takeaways

NDC 00713-0223, representing Lecanemab-irgb (Leqembi), is positioned to capture a significant share of the emerging disease-modifying Alzheimer's disease market. Its patent and exclusivity portfolio provides protection until at least 2037, with significant market exclusivity expected well into the next decade. The drug's novel mechanism, coupled with a favorable CMS NCD, underpins substantial market size projections, potentially exceeding $10 billion annually by 2030. The current list price of approximately $26,500 per year is expected to remain stable in the near to medium term, with potential net price adjustments driven by competition and payer negotiations. Key risks include safety concerns related to ARIA, cost and access barriers, and intense competition from emerging therapies.

Frequently Asked Questions

1. What is the primary indication for Lecanemab-irgb (NDC 00713-0223)? Lecanemab-irgb is indicated for the treatment of early Alzheimer's disease, specifically for patients with mild cognitive impairment or mild dementia stage of disease.

2. When does the primary patent protection for Lecanemab-irgb expire? The primary patent (U.S. Patent No. 10,611,785) protecting Lecanemab-irgb is projected to expire on April 7, 2037, subject to potential patent term extensions.

3. What is the significance of the CMS National Coverage Decision for Lecanemab-irgb? The CMS National Coverage Decision provides Medicare coverage for Lecanemab and other amyloid-beta targeting therapies when certain clinical criteria are met and patients are enrolled in studies or registries, significantly improving market access and patient eligibility.

4. What are the major safety concerns associated with Lecanemab-irgb? The primary safety concern is amyloid-related imaging abnormalities (ARIA), which can include edema and microhemorrhages in the brain.

5. What is the projected annual cost of treatment for Lecanemab-irgb? The wholesale acquisition cost (WAC) is approximately $26,500 per year, based on bi-weekly infusions for a typical patient over an 18-month treatment period.

Citations

[1] Alzheimer's Association. (2023). 2023 Alzheimer's disease facts and figures. Alzheimer's & Dementia, 19(4), 1598-1695. https://doi.org/10.1002/alz.13016

[2] Food and Drug Administration. (2023, July 6). FDA grants traditional approval for Leqembi (lecanemab-irgb) for the treatment of early Alzheimer’s disease. https://www.fda.gov/drugs/news-events-human-drugs/fda-grants-traditional-approval-leqembilecanemab-irgb-treatment-early-alzheimers-disease

[3] Centers for Medicare & Medicaid Services. (2023, April 11). National Coverage Determination for Alzheimer’s Disease Amyloid Detection and Treatment. https://www.cms.gov/medicare/medicare-drug-coverage-part-b-drugs/alzheimers-disease-amyloid-detection-and-treatment

[4] Eisai Inc. (n.d.). Leqembi® (lecanemab-irgb) prescribing information. Retrieved from [Official Leqembi Website/Prescribing Information Portal]