EUCRISA Drug Patent Profile

When do Eucrisa patents expire, and what generic alternatives are available?

Eucrisa is a drug marketed by Anacor Pharms Inc and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-eight patent family members in twenty-eight countries.

The generic ingredient in EUCRISA is crisaborole. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the crisaborole profile page.

DrugPatentWatch^® Generic Entry Outlook for Eucrisa

Eucrisa was eligible for patent challenges on December 14, 2020.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 29, 2029. This may change due to patent challenges or generic licensing.

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (crisaborole), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for EUCRISA

International Patents:	148
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	16
Patent Applications:	841
Drug Prices:	Drug price information for EUCRISA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EUCRISA
What excipients (inactive ingredients) are in EUCRISA?	EUCRISA excipients list
DailyMed Link:	EUCRISA at DailyMed

See drug prices for EUCRISA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for EUCRISA

NDA:

207695

Dosage:

OINTMENT;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for EUCRISA

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

Sponsor	Phase
University of Colorado, Denver	Phase 2
Boston University	Phase 4
Applied Biology, Inc.	Phase 3

See all EUCRISA clinical trials

Pharmacology for EUCRISA

Drug Class	Phosphodiesterase 4 Inhibitor
Mechanism of Action	Phosphodiesterase 4 Inhibitors

Paragraph IV (Patent) Challenges for EUCRISA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EUCRISA	Topical Ointment	crisaborole	2%	207695	5	2021-06-14

US Patents and Regulatory Information for EUCRISA

EUCRISA is protected by four US patents and one FDA Regulatory Exclusivity.

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes					Y
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes					Y
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes					Y
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes					Y
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes

EU/EMA Drug Approvals for EUCRISA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Staquis	crisaborole	EMEA/H/C/004863Staquis is indicated for treatment of mild to moderate atopic dermatitis in adults and paediatric patients from 2 years of age with ≤ 40% body surface area (BSA) affected.	Withdrawn	no	no	no	2020-03-27

International Patents for EUCRISA

When does loss-of-exclusivity occur for EUCRISA?

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

Canada

Cyprus

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 EUCRISA around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	207156	מולקולות קטנות המכילות בור (Boron-containing small molecules)
Hungary	S2000019
South Korea	101819869
Australia	2007214421
World Intellectual Property Organization (WIPO)	2007078340
World Intellectual Property Organization (WIPO)	2006089067

Supplementary Protection Certificates for EUCRISA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2343304	20C1024	France		PRODUCT NAME: CRISABOROLE, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/19/1421 20200401
2343304	C 2020 030	Romania		PRODUCT NAME: CRISABOROL SI SARURILE SALE FARMACEUTIC ACCEPTABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/19/1421; DATE OF NATIONAL AUTHORISATION: 20200327; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1421; DATE OF FIRST AUTHORISATION IN EEA: 20200327
2343304	C202030031	Spain		PRODUCT NAME: CRISABOROL, OPCIONALMENTE EN FORMA DE UNA SAL FARMACEUTICAMENTE ACEPTABLE; NATIONAL AUTHORISATION NUMBER: EU/1/19/1421; DATE OF AUTHORISATION: 20200327; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1421; DATE OF FIRST AUTHORISATION IN EEA: 20200327
2343304	2090017-1	Sweden		PRODUCT NAME: CRISABOROLE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALT; REG. NO/DATE: EU/1/19/1421 20200401
2343304	CA 2020 00022	Denmark		PRODUCT NAME: CRISABOROLE, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1421 20200401
2343304	757	Finland

Market Dynamics and Financial Trajectory for EUCRISA ( crisaborole)

Last updated: July 27, 2025

Introduction

EUCRISA (crisaborole) is a topical phosphodiesterase 4 (PDE4) inhibitor approved by the U.S. Food and Drug Administration (FDA) in 2017 for the treatment of mild to moderate atopic dermatitis in patients aged two years and older. It represents a targeted approach in managing inflammatory dermatoses, harnessing the therapeutic potential of PDE4 inhibition to modulate inflammatory mediators. As the dermatology market witnesses dynamic shifts driven by evolving treatment paradigms and dermatological unmet needs, EUCRISA's market positioning, growth trajectory, and competitive landscape are critical for stakeholders. This analysis explores the market dynamics and financial trajectory for EUCRISA, emphasizing key drivers, challenges, and future outlook.

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Market Context and Therapeutic Landscape

The global dermatology market has experienced robust growth, increasingly driven by an aging population, rising prevalence of atopic dermatitis (AD), and expanding pipeline therapies. According to IQVIA, the dermatology market was valued at approximately USD 22 billion in 2022, with expected compound annual growth rates (CAGR) surpassing 7% through 2027. Within this, atopic dermatitis accounts for a significant share, owing to its high prevalence, estimated at 10-20% among children and up to 3% in adults worldwide [1].

Historically, AD treatments included emollients, topical corticosteroids, and antihistamines. However, long-term corticosteroid use posed safety concerns, prompting the development of steroid-sparing agents, particularly for mild to moderate cases. Dupilumab (Dupixent), a monoclonal antibody targeting IL-4Rα, emerged as the first biologic approved for moderate-to-severe AD, revolutionizing treatment but with considerations regarding cost and administration route.

EUCRISA entered this competitive landscape as an innovative topical agent, offering a non-steroidal, side-effect-friendly option for milder cases. Its pharmacological profile positions it as an alternative to corticosteroids and calcineurin inhibitors, filling a niche in mild-to-moderate AD management.

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Market Dynamics Influencing EUCRISA

1. Clinical Efficacy and Safety Profile

EUCRISA's mechanism of action—selective PDE4 inhibition—reduces inflammatory cytokines implicated in AD without the adverse effects associated with corticosteroids or systemic immunosuppressants. Clinical trials (Phases 3 studies) demonstrated significant improvements in severity scores, such as Eczema Area and Severity Index (EASI), and a favorable safety profile with minimal adverse events [2]. These characteristics position EUCRISA favorably among clinicians seeking topical options with high safety margins for pediatric and adult patients.

2. Regulatory and Reimbursement Environment

Regulatory approvals beyond the U.S., including regulatory review processes in Europe and other regions, influence EUCRISA’s global market penetration. Currently, EUCRISA's approval remains primarily within the U.S., with potential expansion plans contingent upon regulatory submissions. Reimbursement decisions also impact uptake, especially given the cost dynamics between topical small molecules versus biologics and corticosteroids. Favorable reimbursement in key markets could accelerate adoption, while restrictive policies may inhibit growth.

3. Competitive Landscape

EUCRISA faces competition from established therapies. Topical corticosteroids are broadly used given their proven efficacy, low cost, and familiarity. Calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) offer steroid-sparing benefits but have safety concerns, notably regarding long-term use. Biologics such as dupilumab target more severe cases but are costly and require injections. The challenge for EUCRISA lies in establishing a strong foothold in the mild to moderate AD segment, especially considering clinicians' perception of corticosteroids' cost-effectiveness.

4. Market Penetration and Physician Adoption

As a relatively new entrant, EUCRISA's growth depends heavily on physician awareness, prescribing habits, and patient acceptance. Educational initiatives highlighting the drug’s benefits and safety will support adoption, particularly in pediatric dermatology, where safety concerns are paramount. Data demonstrating real-world effectiveness will also be instrumental.

5. Patient Preference and Compliance

Topical agents with minimal side effects tend to have higher patient adherence, especially among pediatric populations. EUCRISA’s favorable safety profile and non-steroidal nature may drive compliance, hence positively influencing its market trajectory.

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Financial Trajectory and Revenue Outlook

1. Sales Performance and Revenue Generation

Since its launch in 2017, EUCRISA’s revenue growth has been modest initially, constrained by limited awareness and competition from steroids. However, as of 2022, incremental uptake has been observed in the U.S., with estimates suggesting hundreds of thousands of prescriptions dispensed annually. Analysts project that EUCRISA could generate peak sales in the vicinity of USD 300-500 million within five years, contingent upon expanded approvals and heightened market penetration [3].

2. Key Revenue Drivers

• Market Penetration in Pediatrics: Given its safety profile, EUCRISA’s key revenue driver will be its utilization in pediatric patients, a demographic where clinicians seek corticosteroid alternatives.
• Geographical Expansion: Entering European and Asian markets will provide significant added revenue streams, assuming regulatory approvals.
• Formulation Advancements: Development of combination therapies or formulations (e.g., once-daily applications) could enhance efficacy and compliance, further influencing sales.

3. Cost Considerations and Pricing Strategy

Pricing strategies must balance profitability with competitiveness. Targeting the mild to moderate segment, where corticosteroids are inexpensive, requires competitive pricing or demonstrating clear value. Costs associated with manufacturing, regulatory compliance, and marketing will influence earnings margins.

4. Market Challenges Impacting Financial Trajectory

• Generic Competition: As patents expire, generic PDE4 inhibitors or alternative small molecules could erode market share.
• Pricing Pressures: Payers impose formulary restrictions and discounts that may limit revenue growth.
• Limited Market Reach: Constraints on approval or clinician hesitancy to prescribe new agents can slow sales momentum.

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Future Outlook and Growth Opportunities

EUCRISA’s trajectory hinges on several strategic factors:

• Regulatory Expansion: Achieving approval in Europe and other regions will be pivotal. The approval process will assess regional data and safety profiles.
• Clinical Data Growth: New studies demonstrating superiority or additive benefits over existing therapies will boost clinician confidence.
• Combination Regimens: Developing combination products with emollients or other anti-inflammatory agents could expand use cases.
• Patient-Centric Initiatives: Digital health initiatives and adherence programs can improve patient experience and persistence.

Amidst these, the market for PDE4 inhibitors in dermatology remains promising, with EUCRISA positioned as a niche but strategic player for mild-to-moderate AD.

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Key Challenges and Risks

• Market Penetration Risks: Entrenched use of corticosteroids may slow adoption unless EUCRISA demonstrates clear advantages.
• Pricing and Cost-effectiveness: Competition from low-cost generics and payer negotiation could limit revenue potential.
• Regulatory Risks: Delays in approval or unfavorable review outcomes outside the U.S. limit growth prospects.
• Clinical Uncertainty: Long-term safety and real-world effectiveness data are needed to sustain market confidence.

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Conclusion

EUCRISA's market dynamics reflect a complex interplay of clinical efficacy, safety profile, competitive positioning, and regional regulatory landscapes. While initially modest, its financial trajectory has potential for significant growth within the growing dermatology market—especially if expanded globally, supported by real-world evidence, and integrated into treatment algorithms for mild-to-moderate AD.

Stakeholders should monitor evolving clinical data, regulatory developments, and market adoption patterns to optimize strategic positioning. The successful expansion of EUCRISA will depend on balancing innovation with economic penetrability within a highly competitive therapeutic landscape.

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Key Takeaways

• EUCRISA (crisaborole) benefits from a targeted, safe profile that appeals to clinicians managing mild to moderate AD, especially in pediatric patients.
• Its financial growth hinges on expanding approval regions, increasing physician awareness, and demonstrating comparative advantages over corticosteroids.
• Market competition, cost pressures, and regulatory hurdles remain significant risk factors that could temper revenue projections.
• Strategic collaborations, formulation advances, and real-world evidence will play crucial roles in enhancing its market penetration.
• Stakeholders should focus on regional regulatory strategies, payer negotiations, and patient-centric marketing to maximize EUCRISA’s commercial potential.

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FAQs

1. What is the primary indication for EUCRISA?
EUCRISA is indicated for the treatment of mild to moderate atopic dermatitis in patients aged two years and older.

2. How does EUCRISA compare to corticosteroids?
EUCRISA offers a steroid-free, well-tolerated alternative with a favorable safety profile, especially suitable for long-term use in sensitive populations like children.

3. What are the key factors influencing EUCRISA’s market growth?
Factors include regulatory approvals outside the U.S., clinical efficacy data, clinician and patient acceptance, reimbursement policies, and competitive dynamics.

4. What are the main barriers to EUCRISA’s commercial success?
Barriers include competition from inexpensive corticosteroids, slow regional approval processes, payer restrictions, and the entrenched use of existing therapies.

5. What future strategies can enhance EUCRISA’s market trajectory?
Developing new formulations, expanding geographically, generating robust real-world evidence, and engaging in educational initiatives are critical strategies.

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References

[1] International Journal of Dermatology. "Epidemiology of Atopic Dermatitis." 2020.
[2] ClinicalTrials.gov. "A Phase 3 Trial of Crisaborole in Atopic Dermatitis." 2021.
[3] Market Research Future. "Dermatology Market Analysis and Forecast." 2022.