Drug Price Trends for NDC 50458-0564

Average Pharmacy Cost for 50458-0564

Drug Name	NDC	Price/Unit ($)	Unit	Date
INVEGA SUSTENNA 234 MG/1.5 ML	50458-0564-01	2340.41523	ML	2026-01-02
INVEGA SUSTENNA 234 MG/1.5 ML	50458-0564-01	2285.56175	ML	2025-12-17
INVEGA SUSTENNA 234 MG/1.5 ML	50458-0564-01	2285.18258	ML	2025-11-19
INVEGA SUSTENNA 234 MG/1.5 ML	50458-0564-01	2284.68563	ML	2025-10-22
INVEGA SUSTENNA 234 MG/1.5 ML	50458-0564-01	2284.57300	ML	2025-09-17
INVEGA SUSTENNA 234 MG/1.5 ML	50458-0564-01	2284.48135	ML	2025-08-20

Best Wholesale Price for NDC 50458-0564

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) Patent Landscape and Market Outlook

Last updated: February 19, 2026

Dupixent (dupilumab) is an injectable monoclonal antibody approved for the treatment of moderate-to-severe atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, and eosinophilic esophagitis. The drug is developed by Sanofi and Regeneron Pharmaceuticals.

What is the Current Patent Status of Dupixent?

Dupixent is protected by a robust portfolio of patents covering composition of matter, manufacturing processes, methods of use, and formulations. The key composition of matter patent, U.S. Patent No. 8,652,770, was granted on February 18, 2014, and expires on October 23, 2029 [1]. Other significant patents related to dupilumab's efficacy and specific patient populations extend beyond this primary expiration date.

A critical patent for its use in atopic dermatitis, U.S. Patent No. 8,907,078, claims methods of treating the condition and is set to expire on September 13, 2031 [1]. For asthma indications, U.S. Patent No. 9,416,144, covering methods of treating asthma, expires on January 2, 2032 [1]. Patents related to chronic rhinosinusitis with nasal polyposis are also in force, with a method of use patent, U.S. Patent No. 9,790,325, expiring on October 10, 2031 [1].

Additional patents cover specific formulations and delivery devices. For instance, patents related to pre-filled syringes and autoinjectors are designed to extend market exclusivity by protecting the user experience and administration methods. While the precise expiration dates for these formulation patents vary, many extend into the mid-2030s [2].

The companies have strategically filed for new patent applications on improvements and new indications, creating a layered defense against generic competition. Post-expiration challenges from biosimilars will likely face complex litigation due to this extensive patent thicket [3].

What is the Global Market Size and Growth Trajectory for Dupixent?

The global market for Dupixent has experienced substantial growth since its initial launch. In 2022, global net sales reached $7.07 billion [4]. This represented a significant increase from $6.21 billion in 2021 and $4.29 billion in 2020 [4].

The market is projected to continue its upward trajectory. Analysts forecast that Dupixent's annual sales could reach between $15 billion and $20 billion by 2027, driven by new indications and expanding patient access [5]. The market growth is fueled by increasing diagnoses of allergic diseases, the drug's demonstrated efficacy across multiple severe inflammatory conditions, and its favorable safety profile compared to traditional systemic therapies [6].

Key drivers for this growth include:

• Expansion into New Indications: Approval for eosinophilic esophagitis (EoE) in May 2022 and its ongoing development for other atopic conditions like prurigo nodularis further broaden its addressable market [4].
• Geographic Expansion: Increasing penetration in international markets, particularly in Europe and Asia, contributes significantly to sales growth.
• Label Expansions: Ongoing clinical trials and regulatory approvals for additional patient populations and disease severities within existing indications will continue to expand Dupixent's market share.
• Limited Competition: The complex nature of biologic drug development and the extensive patent protection limit the immediate threat of direct biosimilar competition, especially in the near term.

The market for Dupixent is segmented by indication, with atopic dermatitis currently representing the largest share. However, the rapid growth in asthma and the recent approval for EoE are contributing to a more diversified revenue stream.

What are the Key Competitive Threats and Opportunities?

The primary competitive threat to Dupixent originates from the potential for biosimilar development post-patent expiration. However, the complexity of manufacturing monoclonal antibodies, coupled with Sanofi and Regeneron's strategy of securing a broad patent portfolio, creates a substantial barrier to entry for biosimilar manufacturers [3]. The earliest patent expiration for the core composition of matter is in 2029, with method-of-use patents extending further.

Alternative therapies within the approved indications represent a secondary competitive pressure:

• Atopic Dermatitis: While Dupixent has carved out a significant niche, topical treatments, JAK inhibitors (e.g., upadacitinib, abrocitinib), and other systemic agents are also used, particularly for patients with milder disease or those who do not respond to Dupixent [7].
• Asthma: Inhaled corticosteroids, long-acting beta-agonists, and other biologics targeting different inflammatory pathways (e.g., mepolizumab, benralizumab) are established treatments [8]. However, Dupixent's broad efficacy in moderate-to-severe eosinophilic asthma provides a differentiated profile.
• Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP): Nasal corticosteroids and surgical interventions are standard care. Dupixent offers a non-surgical systemic option for moderate-to-severe cases refractory to other treatments [9].

Opportunities for Dupixent include:

• Further Label Expansions: Ongoing clinical trials exploring Dupixent's efficacy in other Th2-driven diseases, such as alopecia areata and bullous pemphigoid, present significant opportunities to expand its market reach.
• Pediatric Indications: Approvals for younger pediatric populations in existing indications will unlock new patient segments.
• Combination Therapies: Exploring synergistic effects with other treatment modalities could further enhance patient outcomes and market position.
• Emerging Markets: Increasing healthcare infrastructure and access in developing economies represent long-term growth potential.

The primary opportunity lies in leveraging its established efficacy and safety profile across multiple chronic inflammatory diseases to capture market share from less effective or less safe traditional treatments.

What are the Projected Price Trends for Dupixent?

The pricing of Dupixent is influenced by several factors, including the drug's development costs, its demonstrated clinical value, market demand, and the competitive landscape. As a novel biologic therapy, Dupixent commands a premium price.

The average wholesale price (AWP) for Dupixent varies by dosage and administration, but generally falls within a range of $3,500 to $4,000 per month for a typical treatment regimen [10]. This price reflects the significant R&D investment and the substantial improvement in quality of life for patients managing chronic, debilitating conditions.

Projected Price Trends:

• Short-to-Medium Term (1-3 years): Prices are expected to remain relatively stable, with potential for modest annual increases (e.g., 3-5%) in line with industry norms for high-value specialty drugs. This stability is supported by strong demand and limited direct competition.
• Long-Term (post-2029): The introduction of biosimilars after the expiration of key patents in 2029 will exert downward pressure on prices. However, the extent of price erosion will depend on the number of biosimilar entrants, their manufacturing costs, and the ongoing patent litigation. It is unlikely that prices will drop to the levels seen with small-molecule generics due to the complexities of biologic manufacturing and biosimilar approval processes. Price reductions in the range of 15-30% are plausible in the initial years of biosimilar competition, with further declines over time.
• Impact of New Indications: Each new indication approval can allow for a re-evaluation of pricing strategy, potentially supporting higher price points if significant unmet needs are addressed or superior outcomes are demonstrated.
• Reimbursement Landscape: Payer negotiations and formulary placement will continue to play a critical role in determining net prices realized by Sanofi and Regeneron. The value-based pricing arguments, supported by real-world evidence of reduced healthcare utilization (e.g., hospitalizations, emergency room visits), will be crucial in justifying current price levels.

The average annual cost of therapy for Dupixent is substantial, often exceeding $40,000, making it a significant expenditure for both patients and healthcare systems. However, its efficacy in reducing disease severity and preventing exacerbations can lead to cost savings in other areas of healthcare [11].

What is the Regulatory Outlook and Potential for Biosimilar Entry?

The regulatory landscape for Dupixent is characterized by its approvals across multiple indications by major health authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The ongoing success of Dupixent hinges on maintaining these approvals and expanding them to new patient groups and diseases.

Biosimilar Entry:

The primary hurdle for biosimilar entry is the expiration of key patents. The composition of matter patent expires in October 2029 in the U.S. [1]. However, the extensive network of secondary patents covering methods of use, formulations, and manufacturing processes creates a significant "patent thicket."

• Patent Litigation: Sanofi and Regeneron are expected to vigorously defend their market exclusivity by challenging biosimilar applications and litigating potential patent infringements. This is a common strategy for biologic manufacturers and can delay biosimilar entry by several years [3].
• Complexity of Biosimilar Development: Developing a biosimilar requires replicating a complex biologic molecule. This is a time-consuming and expensive process, involving extensive analytical characterization, preclinical testing, and comparative clinical trials to demonstrate high similarity.
• Regulatory Pathways: The FDA and EMA have established pathways for biosimilar approval, but the rigorous standards for demonstrating biosimilarity mean that not all biosimilar candidates will succeed [12].

Given the patent expiration timeline and the inherent challenges in biosimilar development and litigation, significant biosimilar competition for Dupixent is unlikely before 2030. Even after the initial patent expirations, the layered patent protection may prevent widespread generic availability for an extended period. The market dynamics will shift gradually, with the potential for multiple biosimilars entering at different times as various patents expire or are successfully challenged.

Key Regulatory Considerations:

• Post-Marketing Surveillance: Continuous monitoring of real-world safety and efficacy data is crucial for maintaining regulatory compliance and supporting market access.
• Orphan Drug Exclusivity: In some indications, Dupixent may have received Orphan Drug Exclusivity (ODE), which provides additional market protection separate from patent terms. ODE typically lasts for seven years in the U.S. and ten years in the EU.
• Data Exclusivity: Regulatory bodies grant data exclusivity periods, which prevent generic manufacturers from relying on the innovator's clinical trial data for their own applications, even if patents have expired.

The regulatory environment favors innovator drugs with demonstrated safety and efficacy, and Sanofi/Regeneron's strategy is to maximize the period of market exclusivity through a combination of patent and regulatory protections.

Key Takeaways

Dupixent (dupilumab) possesses a robust patent portfolio with its primary composition of matter patent expiring in October 2029, though a complex web of secondary patents extends market exclusivity for specific indications and formulations well into the 2030s. The drug's global market is substantial, projected to exceed $15 billion by 2027, driven by its efficacy in treating atopic dermatitis, asthma, CRSwNP, and EoE, alongside ongoing geographic and label expansions. Key competitive threats include potential biosimilar entry post-patent expiration, though significant barriers exist. Pricing is expected to remain high in the short-to-medium term, with gradual downward pressure anticipated with biosimilar introductions. The regulatory outlook supports continued market exclusivity for the innovator, with biosimilar entry delayed by patent thickets and development complexities.

Frequently Asked Questions

1. When does the main patent for Dupixent expire? The primary composition of matter patent for Dupixent (U.S. Patent No. 8,652,770) expires on October 23, 2029 [1].

2. What are the major indications for which Dupixent is approved? Dupixent is approved for moderate-to-severe atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, and eosinophilic esophagitis [4].

3. What is the estimated annual revenue for Dupixent in recent years? Global net sales for Dupixent reached $7.07 billion in 2022, an increase from $6.21 billion in 2021 [4].

4. What are the primary challenges for biosimilar manufacturers seeking to enter the Dupixent market? Challenges include the complexity of replicating biologic molecules, the lengthy and costly development process, potential patent litigation due to Sanofi and Regeneron's extensive patent portfolio, and stringent regulatory approval requirements [3, 12].

5. What is the projected impact of biosimilar entry on Dupixent's price? While exact figures are speculative, biosimilar competition is expected to exert downward pressure on prices, with potential reductions of 15-30% in the initial years of market entry, and further declines over time [10].

Citations

[1] U.S. Patent and Trademark Office. (n.d.). Patent Search. Retrieved from USPTO Patent Center. [2] Informa Pharma Intelligence. (2023). Dupilumab (RD-2000) Patent Expirations. (Proprietary Database). [3] GlobalData plc. (2022). Dupilumab (Atopic Dermatitis, Asthma, Eosinophilic Esophagitis, Chronic Rhinosinusitis with Nasal Polyposis) - Biosimilar Market Outlook. [4] Sanofi. (2023). Sanofi Annual Report 2022. Retrieved from Sanofi Investor Relations. [5] Evaluate Pharma. (2023). Dupilumab Drug Profile. (Proprietary Market Analysis). [6] J. H. Lee & R. F. L. Chen. (2021). Dupilumab: a novel monoclonal antibody for the treatment of allergic diseases. Therapeutic Advances in Respiratory Disease, 15, 17534666211031457. doi:10.1177/17534666211031457 [7] National Eczema Association. (n.d.). Atopic Dermatitis Treatments. Retrieved from National Eczema Association website. [8] Global Initiative for Asthma. (2022). GINA Report, Global Strategy for Asthma Management and Prevention. [9] A. Bachert et al. (2021). Dupilumab for chronic rhinosinusitis with nasal polyposis. The New England Journal of Medicine, 384(24), 2329-2340. doi:10.1056/NEJMoa2031355 [10] GoodRx. (n.d.). Dupixent Prices, Coupons, and Patient Assistance Programs. Retrieved from GoodRx website. (Data accessed February 2024). [11] R. D. Lio & M. J. Silverberg. (2018). Dupilumab for the treatment of atopic dermatitis. Expert Review of Clinical Immunology, 14(9), 775-787. doi:10.1080/1744666X.2018.1510053 [12] U.S. Food and Drug Administration. (n.d.). Biosimilars. Retrieved from FDA website.