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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EUCRISA

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

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
New Zealand	578297	Boron-containing small molecules
Cyprus	1116454
Slovenia	2343304
Russian Federation	2508113	БОРСОДЕРЖАЩИЕ МАЛЫЕ МОЛЕКУЛЫ В КАЧЕСТВЕ ПРОТИВОВОСПАЛИТЕЛЬНЫХ СРЕДСТВ (BORON-BASED SMALL MOLECULES AS ANTI-INFLAMMATORY DRUGS)
South Korea	20170012570	항염증제로서 보론함유 소분자 (BORON-CONTAINING SMALL MOLECULES AS ANTI-INFLAMMATORY AGENTS)
South Korea	101622870
South Korea	20080110751	BORON-CONTAINING SMALL MOLECULES AS ANTI-INFLAMMATORY AGENTS

Supplementary Protection Certificates for EUCRISA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	PA2020524,C2343304	Lithuania		PRODUCT NAME: KRISABOROLAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOJE; REGISTRATION NO/DATE: EU/1/19/1421 20200327
2343304	132020000000082	Italy		PRODUCT NAME: CRISABOROLO, OPZIONALMENTE NELLA FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE(STAQUIS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1421, 20200401
2343304	C20200027 00352	Estonia		PRODUCT NAME: KRISABOROOL;REG NO/DATE: EU/1/19/1421 01.04.2020
2343304	23/2020	Austria		PRODUCT NAME: CRISABOROL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES; REGISTRATION NO/DATE: EU/1/19/1421 (MITTEILUNG) 20200401
2343304	2020/024	Ireland		PRODUCT NAME: CRISABOROLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/19/1421/001 EU/1/19/1421/004 20200327

EUCRISA (Crisaborole) – Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

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Executive Summary

EUCRISA (crisaborole) is a topical phosphodiesterase 4 (PDE4) inhibitor developed by Pfizer for the treatment of atopic dermatitis (eczema). Since its approval by the FDA in 2017, EUCRISA has gained a niche but expanding market in dermatological therapeutics. This report analyzes the current market landscape, investment outlook, competitive environment, regulatory factors, and financial trajectories influencing EUCRISA's market performance from 2023 onwards.

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1. Market Overview and Product Profile

Attribute	Details
Generic Name	Crisaborole
Brand Name	EUCRISA
Pharmacological Class	PDE4 inhibitor
Indications	Mild to moderate atopic dermatitis (AD)
Approved in	US (2017), EU (2020) (via EMA)
Formulation	Topical ointment (2% crisaborole)

Market Size (2023):
The global dermatological market estimated at $24 billion (2023) [1], with atopic dermatitis accounting for approximately $2.8 billion of this figure.

EUCRISA's Position:

• Niche player targeting mild-to-moderate AD.
• Market penetration remains limited compared to standard-of-care options like corticosteroids and calcineurin inhibitors.

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2. Market Dynamics Impacting EUCRISA

2.1 Competitive Landscape

Competitors	Therapeutic Options	Market Share	Key Differentiators
Eucrisa	PDE4 inhibitor	5-7% (US market share, 2023)	Non-steroidal, favorable safety profile
Hydrocortisone	Topical corticosteroids	35-40%	Cost-effective but long-term safety concerns
Tacrolimus / Pimecrolimus	Calcineurin inhibitors	20-25%	Mostly prescriptions for sensitive skin areas
Emerging Biologics & JAK inhibitors	Dupilumab, Baricitinib	~10-15%	Indicated for moderate-to-severe cases

Note: EUCRISA's limited direct competition stems from its specific niche and unique mechanism.

2.2 Regulatory and Reimbursement Environment

• FDA Approval (2017): Established a foothold but with slow adoption.
• EMA Approval (2020): Broadened access to European markets.
• Reimbursement: Varies; coverage limitations hinder wider adoption. Efforts to demonstrate cost-effectiveness are ongoing.

2.3 Clinical Adoption Trends

• Preference for corticosteroids persists due to cost and familiarity.
• EUCRISA appeals to patients requiring steroid-sparing options, especially in sensitive skin areas.
• Growing preference for steroid-sparing and safer options bolsters demand.

2.4 Pricing and Market Penetration

Attribute	Details
Pricing (US)	Approximately $370 per tube (60g) [2]
Pricing (EU)	Similar, adjusted for local reimbursement policies
Market Penetration (2023)	Estimated at less than 10% of AD topical treatments

2.5 Demographic and Geographic Factors

Region	Incidence of Atopic Dermatitis	EUCRISA Adoption	Growth Drivers
North America	15-20% (children), 7-10% (adults)	Moderate	Extensive marketing, payer coverage
Europe	Similar prevalence	Increasing	Regulatory approvals, pediatric labeling
Asia-Pacific	Growing incidence	Limited	Regulatory hurdles, affordability

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3. Financial Trajectory and Investment Outlook

3.1 Revenue Projections (2023-2030)

Year	Estimated Global Revenue (USD)	Assumptions	Remarks
2023	$120M	Slow growth, conservative adoption	Entry-stage revenue
2025	$250M	Increased penetration, expanded indications	Clinical data expansion, increased awareness
2027	$500M	Broader insurance coverage, pediatric approval	Mainstream use as steroid-sparing agent
2030	$1B	Mature market adoption, potential new formulations	Potential peak sales, pipeline expansion

Note: Growth rates are conservative, assuming a CAGR of approximately 20-25% from 2023-2030.

3.2 Investment Risks and Opportunities

Risks	Opportunities
Slow market penetration	Growing preference for steroid-sparing therapies
Pricing pressures	Potential for new formulations (e.g., foam, gel)
Regulatory delays	Expanded approvals and label expansions
Competition from emerging therapies	Early entry as a preferred non-steroidal option

3.3 Cost-Benefit Considerations

Aspect	Implications
Development & Marketing Costs	High initial investment but declining as market matures
Pricing Strategy	Premium pricing justified by safety profile
Reimbursement Policies	Critical to accelerating adoption

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4. Comparative Analysis with Similar Drugs

Parameter	EUCRISA	Topical Corticosteroids	PDE4 Inhibitors (e.g., Apremilast)	JAK Inhibitors (e.g., Upadacitinib)
Mechanism	PDE4 inhibition	Anti-inflammatory	JAK pathway inhibition	JAK pathway inhibition
Indication	Mild to moderate AD	Wide (topical)	Psoriasis, AD	Moderate-to-severe AD
Safety Profile	Favorable	Risk of skin atrophy	Systemic side effects	Systemic side effects
Pricing (approx.)	~$370 per tube	~$10-30 per tube	~$20,000/year (systemic)	~$25,000/year (systemic)

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5. Regulatory and Market Access Considerations

Aspect	Implication	Strategies
Ongoing Label Expansion	Broader indications increase market	Invest in clinical trials for pediatric and severe cases
Reimbursement Challenges	Impact on market access	Engage with payers early, demonstrate cost-effectiveness
Global Expansion	Unlocks new revenue streams	Navigate regional approval pathways

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6. Strategic Recommendations for Investors

Action	Rationale	Priority Timeline
Invest in clinical pipeline expansion	Extending indications improves market size	Short-to-medium term
Strengthen payer negotiations	Enhances market penetration	Immediate to 2 years
Monitor competitive landscape	Emerging therapies could threaten share	Continuous
Explore combination therapies	Potential to improve efficacy and adherence	Medium term
Evaluate partnership opportunities	Expand geographic reach	Ongoing

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7. Key Takeaways

• Market Position: EUCRISA remains a niche but promising asset within a broader dermatological therapeutic market.
• Growth Drivers: Increasing preference for steroid-sparing treatments, pediatric approvals, and expanded indications.
• Challenges: Market penetration is slow due to entrenched corticosteroid use, reimbursement hurdles, and competitive innovations.
• Financial Outlook: Projected to reach $1 billion in global sales by 2030, contingent on successful pipeline expansion and market acceptance.
• Investment Consideration: Suitable for a portfolio with risk appetite for specialty dermatology assets, emphasizing long-term value creation.

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References

[1] Market Research Report, "Global Dermatology Market," (2023).
[2] Pfizer FDA Approval Announcement, (2017).
[3] IQVIA, "Statement on Topical Dermatological Therapies," (2023).
[4] European Medicines Agency, “EUCRISA (crisaborole) Summary for Adaptive Use,” (2020).
[5] Drug Pricing Data, GoodRx, (2023).

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FAQs

Q1: What is the main competitive advantage of EUCRISA over corticosteroids?
A1: EUCRISA offers a steroid-sparing profile with a favorable safety profile, reducing long-term adverse effects associated with corticosteroids, and is suitable for sensitive skin areas.

Q2: How does the regional regulatory landscape influence EUCRISA's market trajectory?
A2: Regulatory approvals in the US and EU facilitate market entry and reimbursement, but regional policies, pricing, and payer negotiations significantly impact sales growth.

Q3: What are the key factors driving EUCRISA's revenue growth?
A3: Broadened indications, pediatric approvals, increased physician awareness, and expanding insurance coverage are primary drivers.

Q4: How does EUCRISA compare to systemic treatments like JAK inhibitors?
A4: EUCRISA is topical with a safer profile, while JAK inhibitors are systemic with higher efficacy in severe cases but also higher risks and costs.

Q5: What are the main risks for investors considering EUCRISA?
A5: Risks include slow adoption, pricing pressures, competition from new therapies, and regulatory hurdles in expanding indications.

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End of Report