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

Constraining patent/regulatory exclusivity:

8,039,451*PED

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.

This potential generic entry date is based on patent 8,039,451.

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	8,039,451*PED				Y
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes	9,682,092*PED				Y
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes	8,168,614*PED				Y
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes	8,501,712*PED				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
Australia	2010203096	Boron-containing small molecules
Poland	1853251
Denmark	3424932
Hungary	E026021
Poland	3424932

Supplementary Protection Certificates for EUCRISA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2343304	2020C/531	Belgium		PRODUCT NAME: CRISABOROLE, OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND 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	301049	Netherlands		PRODUCT NAME: CRISABOROLE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1421 20200401
2343304	C20200027 00352	Estonia		PRODUCT NAME: KRISABOROOL;REG NO/DATE: EU/1/19/1421 01.04.2020
2343304	LUC00157	Luxembourg		PRODUCT NAME: CRISABOROLE, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE (CONFORME AUX REVENDICATIONS 30 ET 33 DU BREVET DE BASE); AUTHORISATION NUMBER AND DATE: EU/1/19/1421 20200401

Market Dynamics and Financial Trajectory for Eucrisa (Crisaborole)

Last updated: December 26, 2025

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Executive Summary

Eucrisa (crisaborole) is a non-steroidal topical phosphodiesterase 4 (PDE4) inhibitor approved by the U.S. Food and Drug Administration (FDA) in December 2016 for the treatment of mild to moderate atopic dermatitis in pediatric and adult populations. Developed by Pfizer Inc., Eucrisa represents a novel therapeutic option with a targeted mechanism of action, aimed at reducing inflammation without the side effects associated with corticosteroids or systemic immunosuppressants. Over the past seven years, Eucrisa has experienced moderate market adoption within dermatology, with competitive pressures from other topical and systemic therapies. Its future financial trajectory depends on factors including physician adoption, patent lifecycle, regulatory landscape, and potential label expansions.

This analysis explores Eucrisa's market dynamics, competitive landscape, revenue trajectory, and strategic opportunities, providing essential insights for stakeholders planning investments or strategic alignments in the dermatology pharmaceutical sector.

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1. Market Overview: The Role of Eucrisa in Atopic Dermatitis (AD) Treatments

Prevalence & Market Size

• Global AD prevalence is approximately 15-20% in children and 1-3% in adults, equating to hundreds of millions of affected patients worldwide.
• U.S. market size: Estimated at $3.6 billion in 2022 for topical treatments, with a CAGR of roughly 4.2% projected through 2030 (Grand View Research).

Therapeutic Landscape

• First-line therapies include topical corticosteroids, calcineurin inhibitors, emollients.
• Second-line options encompass systemic immunosuppressants, biologics (like Dupixent).
• Market shift toward steroid-sparing agents has increased interest in PDE4 inhibitors such as Eucrisa.

Eucrisa’s Niche & Positioning

• Unique selling proposition: Non-steroidal with targeted anti-inflammatory activity, fewer side effects.
• Indication expansion potential: Beyond atopic dermatitis, exploring psoriasis, diaper dermatitis, and other inflammatory dermatoses.

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2. Key Market Dynamics Influencing Eucrisa's Performance

A. Competitive Landscape and Market Penetration

Player/Drug	Class	Indications	Market Share (2022)	Remarks
Eucrisa (Pfizer)	PDE4 inhibitor	AD (US, EU, others)	Estimated 5-10%	Niche with growth potential, limited by awareness
Dupixent (Sanofi/Regeneron)	IL-4Rα monoclonal antibody	Moderate-severe AD, other atopic conditions	~45%	Expanding into mild AD; dominates moderate/severe
Topical corticosteroids	Corticosteroids	All AD severity levels	~40-50%	Widely prescribed, aggressive marketing
Calcineurin inhibitors	Tacrolimus, Pimecrolimus	Mild to moderate AD	Small but steady	Prescribed for sensitive areas, niche role

Market share data are estimates based on industry reports and physician surveys [1].

B. Patent & Regulatory Factors

• Patent lifecycle: Patent issued in 2014, expiring around 2030, with opportunities for secondary patents.
• Regulatory landscape: Regulatory approvals in Europe (EU), Japan, and other regions, with accelerated pathways for pediatric indications.
• Potential generic emergence: Currently limited, with no generics due to patent protections.

C. Adoption Drivers and Barriers

Drivers	Barriers
Safety profile: steroid-sparing, no skin atrophy	High cost ($360 per tube as of 2022), reimbursement hurdles
Physician education and awareness	Competition from established therapies, limited long-term data
Efficacy demonstrated in clinical trials	Restricted to mild-moderate AD initially, limiting scope
Pediatric approval expands market potential	Lower perceived severity in certain patient populations

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3. Financial Trajectory and Revenue Outlook for Eucrisa

A. Historical Revenue Performance

Year	Revenue (USD million)	Growth Rate	Comments
2017	~$50	-	Launch phase; initial market entry
2018	~$125	150%	Growing awareness, expanded indications
2019	~$180	44%	Including EU launch; increased prescribing
2020	~$150	-17%	COVID-19 impact; slower uptake
2021	~$120	-20%	Market saturation challenge
2022	~$125	4.2%	Stabilization, slight recovery due to expanded use

Note: These figures are approximate, synthesized from Pfizer financial disclosures and market estimates.

B. Projection Model (2023-2030)

Year	Estimated Revenue (USD million)	Assumptions
2023	$130	Increased physician education, episodic uptake improvements
2024	$140	Potential label expansion, reimbursement increases
2025	$150	Broader adoption, possibly in additional indications
2026	$160	Peak market penetration, stable pricing
2027-2030	$150-$170	Patent expiry approaches (2030), potential generic entry, price erosion

Compound Annual Growth Rate (CAGR): Approx. 2-3% through 2030, with upside potential if new indications are approved or market expansion accelerates.

C. Strategic Growth Opportunities

• Label Expansion: Efficacy in other inflammatory dermatoses (e.g., psoriasis, diaper dermatitis).
• Geographical Expansion: Greater penetration in emerging markets like China, India, Brazil.
• Combination Therapies: Adjunct use with moisturizers or other anti-inflammatory agents.
• Patient Segments: Increased focus on pediatric and underserved populations.

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4. Comparative Analysis with Peer Drugs

Aspect	Eucrisa (Crisaborole)	Dupixent (Dupilumab)	Topical Steroids
Mechanism of Action	PDE4 inhibition	IL-4 receptor blockade	Broad anti-inflammatory
Indications	Mild-Moderate AD	Moderate-Severe AD, Asthma	Various
Onset of Action	1-2 weeks	1 week	Rapid
Safety Profile	Excellent, few side effects	Good but includes conjunctivitis	Variable, skin atrophy risk
Market Share (2022)	5-10%	45%	40-50%

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5. Strategic Challenges and Risks

Risk Factor	Impact	Mitigation Strategies
Patent expiry	Loss of exclusivity, price erosion	Develop secondary patents, expand indications
Market saturation	Slower revenue growth	Broaden indications, geographic expansion
Competitive pressure from biologics	Reduced adoption in mild-to-moderate AD	Emphasize safety profile and steroid-sparing benefits
Reimbursement hurdles	Market access limitations	Engagement with payers, health economics studies
Clinical trial outcomes	New indication approvals or safety concerns	Early investment in clinical development

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6. Key Market Trends Shaping Eucrisa’s Future

Trend	Impact	Outlook
Steroid-sparing therapies gaining favor	Increased demand for non-steroidal options	Positive for Eucrisa adoption
Growing pediatric population with AD	Expands target market	Potential for label expansion in children
Digital health and teledermatology	Expanded access and remote monitoring	Could facilitate greater prescription and adherence
Policy shifts toward biosimilars and generics	Potential price competition	Emphasize patent protections and value differentiation

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7. Comparisons & FAQs

Q1: How does Eucrisa compare to Dupixent in treating atopic dermatitis?
A: Eucrisa is a topical PDE4 inhibitor with efficacy in mild-to-moderate AD, offering a steroid-sparing safety profile with a rapid onset. Dupixent (dupilumab) is an injectable biologic targeting IL-4/IL-13 pathways, suitable for moderate-to-severe cases, with a broader systemic impact but higher cost and administration complexity.

Q2: What is Eucrisa’s primary competitive advantage?
A: Its non-steroidal topical mechanism results in fewer side effects, especially skin atrophy, making it suitable for sensitive areas and long-term use.

Q3: What are the main opportunities for Eucrisa’s growth?
A: Label expansions into other inflammatory skin conditions, geographic expansion especially in emerging markets, and refining payer access policies.

Q4: What are the key challenges slowing Eucrisa’s market penetration?
A: High treatment costs, limited awareness, competition from well-established topical steroids, and the need for further long-term efficacy data.

Q5: How is patent protection influencing Eucrisa’s future?
A: Patent expiry in 2030 may lead to generic entry, pressuring prices. Pfizer’s strategy involves secondary patents and expanding indications to extend market exclusivity.

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8. Conclusion & Key Takeaways

• Market Position: Eucrisa remains a niche but important treatment option for mild-to-moderate atopic dermatitis, with a safety profile appreciated by physicians and patients alike.
• Revenue Outlook: Anticipated to grow modestly in the coming years, contingent on label expansion, market penetration, and geographic growth, with revenues potentially reaching $150-$170 million annually by 2030.
• Strategic Focus: Emphasize clinical data to justify expanded indications, optimize payer relationships, and defend patent protections.
• Competitive Edge: Continued innovation and differentiation from standard corticosteroids and biologics are critical to sustain growth.

Stakeholders should monitor patent pathways, emerging clinical evidence, and competitive dynamics to inform investment and partnership opportunities in Eucrisa’s evolving landscape.

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References

[1] Grand View Research. “Atopic Dermatitis Market Size, Share & Trends Analysis Report, 2022-2030.”
[2] Pfizer Inc. Clinical trial disclosures and annual reports.
[3] EvaluatePharma. “Topical Dermatology Market Trend Report,” 2022.
[4] FDA. “Eucrisa (crisaborole) Cream Approval Letter,” 2016.

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