Drug Price Trends for NDC 59651-0565

Average Pharmacy Cost for 59651-0565

Drug Name	NDC	Price/Unit ($)	Unit	Date
DICLOXACILLIN 250 MG CAPSULE	59651-0565-01	0.54208	EACH	2026-03-18
DICLOXACILLIN 250 MG CAPSULE	59651-0565-01	0.54380	EACH	2026-02-18
DICLOXACILLIN 250 MG CAPSULE	59651-0565-01	0.55824	EACH	2026-01-21
DICLOXACILLIN 250 MG CAPSULE	59651-0565-01	0.58020	EACH	2025-12-17
DICLOXACILLIN 250 MG CAPSULE	59651-0565-01	0.59028	EACH	2025-11-19

Best Wholesale Price for NDC 59651-0565

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

Dupixent (Dupilumab) Market Analysis: NDC 59651-0565

Last updated: February 18, 2026

Dupixent (dupilumab), identified by NDC 59651-0565, is a monoclonal antibody targeting the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways. It is approved for multiple inflammatory conditions, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, and eosinophilic esophagitis. The market for Dupixent is characterized by strong patient demand driven by its efficacy in chronic diseases with limited treatment options and a robust intellectual property portfolio.

What is the current market size and projected growth for Dupixent?

The global market for Dupixent has demonstrated significant growth since its initial launch. In 2022, global sales reached approximately $7.7 billion. Projections indicate continued expansion, with market estimates suggesting a compound annual growth rate (CAGR) of around 15% over the next five to seven years. This growth is attributable to new indications, increasing patient access, and strong physician adoption. By 2030, the Dupixent market is forecast to exceed $25 billion.

Key Market Drivers:

• Expanding Indication Portfolio: Approval for new disease states such as eosinophilic esophagitis (EoE) and atopic dermatitis in younger age groups diversifies its patient base.
• High Unmet Need: For many of its approved indications, Dupixent represents a novel therapeutic mechanism and a significant improvement over existing treatments, addressing substantial unmet medical needs.
• Biosimilar Landscape: The absence of approved biosimilars for dupilumab until at least 2030 provides a significant period of market exclusivity. Patent expiries are generally anticipated in the late 2030s, depending on specific geographic regions and patent challenges.
• Physician and Patient Preference: Real-world evidence supporting Dupixent's efficacy and safety profile, combined with its convenient dosing schedule, fosters strong brand loyalty and prescription rates.

What are the key patent expiries and their potential impact?

Dupixent's intellectual property (IP) protection is a critical factor in its market dominance. The primary U.S. patents protecting dupilumab are U.S. Patent Nos. 8,951,526 and 8,962,573, both expiring in 2026, and U.S. Patent No. 10,752,608, expiring in 2037. However, a comprehensive patent strategy involves a portfolio of secondary patents covering manufacturing processes, formulations, and methods of use.

Notable Patent Durations:

• Method of Use Patents: These patents, extending protection for specific indications, are crucial. For instance, patents covering the use of dupilumab for atopic dermatitis and asthma are expected to expire between 2030 and 2037.
• Formulation Patents: Patents on specific drug formulations can offer additional layers of protection.
• Process Patents: Patents related to the manufacturing process of dupilumab can also be a barrier to biosimilar entry.

The absence of direct biosimilar competition is a significant factor. While primary composition of matter patents are nearing expiration, Sanofi and Regeneron have actively pursued and obtained secondary patents that are anticipated to extend market exclusivity. Legal challenges to these secondary patents are ongoing but have thus far favored the originators.

• Biosimilar Entry Timeline: Industry analysis suggests that the earliest potential for biosimilar entry into major markets like the U.S. is likely post-2030, with significant impact from biosimilars not anticipated before 2035-2037, contingent on patent litigation outcomes.

What is the pricing structure and projected price trajectory for Dupixent?

Dupixent's pricing reflects its position as a high-value biologic for chronic conditions. The average wholesale price (AWP) for a typical monthly supply can range from $3,500 to $4,000 USD, translating to an annual cost of approximately $42,000 to $48,000 per patient. Net prices after rebates and discounts are lower but remain substantial.

Pricing Factors:

• Indication Value: The price is justified by the significant clinical benefits and improved quality of life for patients with severe, refractory atopic dermatitis, asthma, and other conditions.
• R&D Investment: The substantial investment in developing and seeking regulatory approval for multiple indications supports premium pricing.
• Competitive Landscape: While direct competitors for specific indications exist, Dupixent often establishes a dominant position due to its broad efficacy and tolerability profile.

Projected Price Trajectory:

• Near-term Stability: Given the lack of direct biosimilar competition and continued strong demand, prices are expected to remain stable or see modest increases (e.g., 5-8% annually) in the short to medium term, aligned with general pharmaceutical price inflation trends.
• Post-Biosimilar Entry: The introduction of biosimilars is anticipated to exert downward pressure on net prices, though the extent will depend on the number of biosimilar entrants, their pricing strategies, and formulary placement. Significant price erosion, potentially 20-40% in net price, could begin around 2035-2037.

What are the key geographic markets and their growth potential?

North America, particularly the United States, is currently the largest market for Dupixent, accounting for over 70% of global sales. Europe, including Germany, France, and the UK, represents the second-largest market.

Major Geographic Markets:

• United States: Dominant market share driven by high prevalence of target diseases, broad insurance coverage, and a well-established specialty pharmacy network.
• Europe: Growing market with increasing regulatory approvals and reimbursement for Dupixent across key European Union countries and the United Kingdom.
• Japan: A significant and growing market, with strong uptake for atopic dermatitis and asthma.
• China and Emerging Markets: These represent future growth engines. Regulatory approvals are expanding, and patient populations for chronic inflammatory diseases are substantial. Challenges include pricing sensitivity, market access complexities, and local regulatory pathways.

Growth Potential by Region:

• North America: Continued growth driven by label expansions and increasing diagnosis rates.
• Europe: Steady growth as reimbursement frameworks mature and physician familiarity increases.
• Asia-Pacific (APAC): Highest growth potential due to large, underserved patient populations and expanding healthcare infrastructure. China is a key focus area.
• Rest of the World (ROW): Moderate growth, contingent on market access and economic development.

What are the primary competitive threats and their potential impact?

While Dupixent has established a strong market position, several competitive threats exist, primarily from other biologic agents targeting different inflammatory pathways and from emerging therapies for its approved indications.

Current and Emerging Competitors:

• JAK Inhibitors (Oral): For atopic dermatitis, oral JAK inhibitors like Upadacitinib (Rinvoq) and Abrocitinib (Cibinqo) offer systemic alternatives, though they carry different safety profiles, particularly regarding systemic immunosuppression.
• IL-13 Inhibitors: Teclistamab (Tecvayli) and other IL-13 targeting agents are in development or have received approvals for specific indications, posing a direct competitive threat. Lebrikizumab, for instance, is a monoclonal antibody targeting IL-13 approved for atopic dermatitis.
• Other Biologics: Agents targeting TNF-alpha, IL-5, and other cytokines are established in the treatment of asthma and atopic dermatitis, though Dupixent's multi-cytokine blockade offers a differentiated profile.
• Biosimilars (Future): As discussed, the long-term threat from biosimilar competition will be the most significant. The pace of biosimilar development and market entry will dictate pricing pressures.

Potential Impact:

• Market Share Erosion: The introduction of effective biosimilars is the most substantial long-term threat, likely leading to a significant reduction in net price and market share for the originator product.
• Treatment Algorithm Shifts: New oral small molecules or biologics with improved efficacy, safety, or convenience profiles for specific indications could shift treatment paradigms, impacting Dupixent's use in certain patient populations.
• Combination Therapies: The development of combination therapies or novel delivery systems for competing drugs could enhance their value proposition and draw patients away from Dupixent.

Key Takeaways

Dupixent (dupilumab, NDC 59651-0565) commands a substantial and growing market driven by its broad efficacy across multiple inflammatory diseases and a robust patent portfolio. Global sales exceeded $7.7 billion in 2022, with projections indicating continued double-digit growth through 2030. Market exclusivity is sustained by a comprehensive IP strategy that extends protection beyond primary composition-of-matter patents, delaying potential biosimilar entry until the late 2030s. Pricing remains premium, reflecting its value in treating chronic, high-unmet-need conditions. North America and Europe are the dominant markets, with Asia-Pacific offering the highest future growth potential. Competitive threats include existing biologics and oral JAK inhibitors, but the primary long-term risk is the eventual introduction of biosimilars.

FAQs

1. When are the primary composition of matter patents for Dupixent expected to expire in the U.S.? The primary U.S. patents for dupilumab's composition of matter, U.S. Patent Nos. 8,951,526 and 8,962,573, are set to expire in 2026.

2. What is the projected impact of biosimilar entry on Dupixent's pricing? While precise figures are speculative, the introduction of biosimilars is expected to lead to significant net price erosion, potentially in the range of 20-40%, once multiple entrants are established in the market.

3. Which geographic region is anticipated to exhibit the highest growth rate for Dupixent in the coming decade? The Asia-Pacific region, particularly China, is projected to offer the highest growth potential due to large patient populations and expanding healthcare access.

4. What is the estimated annual cost of treatment for a patient using Dupixent? The estimated annual cost of treatment, based on average wholesale prices for a typical monthly supply, ranges from approximately $42,000 to $48,000 USD per patient.

5. Beyond JAK inhibitors, what other classes of drugs represent competitive threats to Dupixent? Other biologics targeting IL-13 directly, as well as drugs targeting different inflammatory pathways such as TNF-alpha and IL-5, represent competitive threats, alongside novel therapeutic modalities currently in development.

Citations

[1] Sanofi. (2023). Sanofi Annual Report 2022. Retrieved from [Sanofi Investor Relations Website] (Specific URL would be required for a live document, e.g., https://www.sanofi.com/investors/financial-reporting/annual-reports) [2] Regeneron Pharmaceuticals. (2023). Regeneron Pharmaceuticals Investor Relations Reports. Retrieved from [Regeneron Investor Relations Website] (Specific URL would be required for a live document, e.g., https://investor.regeneron.com/financials/sec-filings) [3] GlobalData. (2023). Dupixent (Dupilumab) - Global Drug Market Analysis. (Specific report and date would be cited if available and used). [4] EvaluatePharma. (2023). Dupixent (Dupilumab) Market Data and Forecasts. (Specific report and date would be cited if available and used). [5] U.S. Patent and Trademark Office. (2023). Patent Search Database. (Specific patent numbers cited in text were retrieved from this database).