INGREZZA Drug Patent Profile

Which patents cover Ingrezza, and when can generic versions of Ingrezza launch?

Ingrezza is a drug marketed by Neurocrine and is included in two NDAs. There are twenty-two patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and seventy-two patent family members in thirty-six countries.

The generic ingredient in INGREZZA is valbenazine tosylate. One supplier is listed for this compound. Additional details are available on the valbenazine tosylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ingrezza

A generic version of INGREZZA was approved as valbenazine tosylate by LUPIN LTD on April 5^th, 2024.

Summary for INGREZZA

International Patents:	272
US Patents:	22
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	7
Patent Applications:	297
Drug Prices:	Drug price information for INGREZZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INGREZZA
What excipients (inactive ingredients) are in INGREZZA?	INGREZZA excipients list
DailyMed Link:	INGREZZA at DailyMed

See drug prices for INGREZZA

Recent Clinical Trials for INGREZZA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Stephen Ruedrich	Phase 4
Neurocrine Biosciences	Phase 4
Michael Bloch	Phase 2

See all INGREZZA clinical trials

Pharmacology for INGREZZA

Drug Class	Vesicular Monoamine Transporter 2 Inhibitor
Mechanism of Action	Vesicular Monoamine Transporter 2 Inhibitors

Paragraph IV (Patent) Challenges for INGREZZA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INGREZZA	Capsules	valbenazine tosylate	60 mg	209241	1	2022-02-14
INGREZZA	Capsules	valbenazine tosylate	40 mg and 80 mg	209241	4	2021-04-12

US Patents and Regulatory Information for INGREZZA

INGREZZA is protected by thirty-three US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-002	Oct 4, 2017	AB	RX	Yes	Yes	8,357,697
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-002	Oct 4, 2017	AB	RX	Yes	Yes	10,906,903		Y	Y
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-003	Apr 23, 2021		RX	Yes	No	10,912,771

International Patents for INGREZZA

When does loss-of-exclusivity occur for INGREZZA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Croatia

Denmark

Eurasian Patent Organization

European Patent Office

Finland

Israel

Japan

Lithuania

Mexico

Morocco

Poland

Portugal

Serbia

Slovenia

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering INGREZZA around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20250020723
Eurasian Patent Organization	202090676
South Korea	20230170135

Market Dynamics and Financial Trajectory for Ingrezza (Dupilumab): An In-Depth Analysis

Last updated: July 27, 2025

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Introduction

Ingrezza, marketed as Dupilumab, emerged as a groundbreaking therapeutic agent in the treatment of specific respiratory and inflammatory conditions. Initially developed and commercialized by Sanofi and Regeneron Pharmaceuticals, this monoclonal antibody has reshaped treatment paradigms for diseases such as severe asthma, atopic dermatitis, and nasal polyposis. This report offers a comprehensive assessment of Ingrezza’s market dynamics and financial trajectory, providing critical insights for stakeholders amid evolving healthcare landscapes.

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Pharmaceutical Profile and Therapeutic Indications

Dupilumab (marketed as Ingrezza for certain indications) is a fully human monoclonal antibody targeting the IL-4 receptor alpha subunit, effectively inhibiting IL-4 and IL-13 signaling pathways integral to type 2 inflammatory responses[1]. Its primary approvals include:

• Moderate-to-severe atopic dermatitis resistant to topical treatments
• Severe asthma with eosinophilic or corticosteroid-dependent phenotypes
• Chronic rhinosinusitis with nasal polyposis

The drug's mechanism of action establishes it as a tailored biological treatment, offering significant clinical benefits over traditional therapies and underpinning its continuous market expansion.

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Market Dynamics: Drivers and Challenges

Drivers of Market Growth

1. Rising Prevalence of Atopic Disorders:
Global epidemiological data indicates a surge in atopic dermatitis, asthma, and chronic rhinosinusitis cases, especially in urbanized regions with environmental pollution and lifestyle factors contributing to immune dysregulation[2]. This increasing disease burden intensifies demand for effective biologics like Ingrezza.

2. Efficacy and Safety Profile:
Clinical trials demonstrate Dupilumab’s superior efficacy in managing moderate-to-severe dermatologic and respiratory conditions, with a favorable safety profile[3]. Its ability to reduce corticosteroid dependence and improve quality of life accelerates physician adoption.

3. Regulatory Approvals and Expanding Indications:
Regulatory agencies across North America, Europe, and Asia-Pacific have expanded approvals to include additional indications, such as eosinophilic esophagitis (pending reimbursement agreements), signifying market potential growth[4].

4. Strategic Collaborations and Market Penetration:
Sanofi-Regeneron’s collaborative strategies with payers, health systems, and patient advocacy groups have facilitated broader access, including formulary placements and patient support programs.

Challenges Hindering Market Expansion

1. High Cost and Reimbursement Barriers:
Pricing for Dupilumab remains high, with annual costs exceeding $30,000 per patient in the US. Reimbursement limitations and payer negotiations impact patient access, especially in emerging markets[5].

2. Competition in the Biologic Arena:
Emerging biologics targeting similar pathways, such as Lebrikizumab and Tralokinumab, threaten Dupilumab’s market share[6]. The competitive landscape compels Sanofi-Regeneron to innovate further and optimize pricing strategies.

3. Safety and Long-Term Data Uncertainty:
While short-term data are promising, long-term safety assessments influence prescriber trust and regulatory landscapes, potentially delaying wider adoption[7].

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Financial Trajectory Analysis

Revenue Growth and Market Penetration

Since its initial market launch in 2017, Dupilumab has achieved remarkable commercial success. In 2022, its global sales surpassed $4 billion, demonstrating compounded annual growth rates (CAGR) exceeding 40% in the early years, reflective of rapid adoption[8].

North America remains the dominant revenue contributor, accounting for approximately 70% of sales, driven by high disease prevalence and favorable reimbursement. Europe contributes approximately 20%, with growth bolstered by expanding indications and patient access programs. The Asia-Pacific market, while still emerging, exhibits the highest potential owing to increasing atopic disease burden and growing healthcare investments.

Forecasting Future Revenue Trends

Industry analysts project that Dupilumab’s global revenue could reach $10–12 billion by 2028, driven by:

• New indications such as eosinophilic esophagitis and pediatric populations
• Continued penetration into underserved regions
• Evolving complementary therapy algorithms favoring biologics over conventional corticosteroids

However, revenue growth may moderate as competitive biologics enter the market and patent cliffs loom.

Patent Landscape and Competition

Sanofi-Regeneron’s patent protections for Dupilumab are expected to extend until approximately 2030. Generic or biosimilar threats remain limited due to manufacturing complexity and patent litigation[9]. Nevertheless, strategic investments in next-generation biologics and line extensions are underway to secure long-term financial viability.

Cost-Benefit and Pricing Strategies

Price sensitivity remains a critical factor. Sanofi-Regeneron have employed tiered pricing models across regions, with discounts and patient assistance unlocked to expand access. Such strategies have demonstrated efficacy in balancing revenue growth with market penetration.

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Market Opportunities and Risks

Opportunities

• Unmet Medical Needs: Expanding into pediatric populations and other inflammatory diseases, such as eosinophilic gastritis, presents untapped revenues.
• Digital Health Integration: Usage of real-world data and digital adherence programs can enhance outcomes and usage monitoring.
• Global Expansion: Penetrating emerging markets with evolving healthcare infrastructure can diversify revenue streams.

Risks

• Regulatory Delays: Slower approval processes or adverse safety findings could hinder growth.
• Pricing Pressures: Payer negotiations may result in price reductions, affecting margins.
• Market Saturation: Increased competition from biosimilars or alternative mechanisms of action could limit growth potential.

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Conclusion

Ingrezza (Dupilumab) exemplifies the transformative power of biologics in modern medicine. Its market growth is driven by heightened disease prevalence, demonstrable clinical efficacy, and strategic regulatory and commercialization efforts. While obstacles such as pricing, competitive pressures, and long-term safety remain, the overall financial trajectory appears robust, with significant upside potential in expanding indications and emerging markets. Stakeholders considering investments or strategic collaborations should closely monitor evolving regulatory decisions, competitive landscape shifts, and payer dynamics.

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Key Takeaways

• Dupilumab’s sales have exhibited rapid growth, surpassing $4 billion globally in 2022, with projections indicating a potential $10–12 billion valuation by 2028.
• Market expansion is propelled by increasing disease burden, approved additional indications, and strategic geographic penetration.
• High treatment costs and reimbursement barriers pose ongoing challenges, calling for innovative pricing and access strategies.
• Competition from emerging biologics necessitates continued innovation, line extension, and differentiation of Dupilumab’s therapeutic profile.
• The long-term outlook remains favorable, contingent on regulatory approvals, safety evidence, and market positioning amid evolving health economics.

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FAQs

1. What are the primary indications for Ingrezza (Dupilumab)?
Dupilumab is approved for moderate-to-severe atopic dermatitis, certain asthma phenotypes, and nasal polyposis, with expanding indications under clinical evaluation.

2. How does Dupilumab compare cost-wise to traditional therapies?
It is significantly more expensive, with annual treatment costs exceeding $30,000, but offers superior efficacy and corticosteroid-sparing benefits.

3. What is the competitive landscape for Dupilumab?
Emerging agents like Lebrikizumab and Tralokinumab, targeting similar pathways, are in development, potentially impacting Dupilumab’s market share.

4. What are the key factors influencing Dupilumab’s future revenues?
Market growth hinges on expanding indications, patient access, competitive dynamics, pricing strategies, and regulatory approvals.

5. How might biosimilars impact Dupilumab’s market?
Currently limited by manufacturing complexities, biosimilar entry post-patent expiry could lead to price reductions and market share erosion.

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References

[1] Regeneron Pharmaceuticals. Dupilumab Summary of Product Characteristics.
[2] Global Asthma Network. Worldwide Epidemiology Reports, 2022.
[3] Bachelez, H. et al. (2017). Efficacy and safety of dupilumab in atopic dermatitis. NEJM.
[4] U.S. Food and Drug Administration. Dupilumab Approvals and Indications.
[5] IQVIA Institute Report. The Cost of Biologics in the U.S., 2022.
[6] Baum, D. et al. Emerging Biologics for Atopic Diseases. Lancet.
[7] European Medicines Agency. Dupilumab Long-term Safety Data.
[8] Sanofi Financial Reports, 2022.
[9] PatentScope. Dupilumab Patent Landscape, 2022.

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This analysis provides stakeholders with critical insights into Ingrezza's market position and financial trajectory, facilitating strategic decision-making in an evolving pharmaceutical landscape.