EUCRISA Drug Patent Profile

Which patents cover Eucrisa, 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
Poland	1853251
Luxembourg	C00157
Portugal	2719388
South Africa	200806754	BORON-CONTAINING SMALL MOLECULES AS ANTI-INFLAMMATORY AGENTS
Portugal	2719388
South Korea	20080110751
South Korea	20150004937	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	C20200027 00352	Estonia		PRODUCT NAME: KRISABOROOL;REG NO/DATE: EU/1/19/1421 01.04.2020
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
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	23/2020	Austria		PRODUCT NAME: CRISABOROL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES; REGISTRATION NO/DATE: EU/1/19/1421 (MITTEILUNG) 20200401
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	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
2343304	301049	Netherlands		PRODUCT NAME: CRISABOROLE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1421 20200401

Market Dynamics and Financial Trajectory for Eucrisa (crisaborole)

Last updated: February 20, 2026

What is the current market size for Eucrisa?

Eucrisa (crisaborole) is a topical phosphodiesterase 4 (PDE4) inhibitor developed by Pfizer for atopic dermatitis (eczema). Its global sales in 2022 reached approximately $250 million, with the U.S. accounting for approximately 90% of revenue. The drug's key markets include the U.S. and select European countries.

How has Eucrisa's sales evolved since launch?

• Launched in the U.S. in 2017.
• Achieved peak U.S. sales of around $300 million in 2021.
• In 2022, U.S. sales declined to $225 million, attributed primarily to increased competition and market saturation.

What are the major factors influencing Eucrisa's market performance?

Competitive landscape

• Dupilumab (Dupixent) by Sanofi/Regeneron dominates the eczema market with $4.8 billion global sales in 2022.
• Topical corticosteroids like hydrocortisone remain widely prescribed but are less targeted.
• Emerging topical PDE4 inhibitors in development may threaten Eucrisa's market share.

Regulatory status

• Approved in the U.S. for children aged 2 and older.
• Approved in the European Union in 2019 with restricted indications.
• No significant recent regulatory changes affecting approval status as of 2023.

Clinical positioning

• Offers a non-steroidal topical option for mild to moderate atopic dermatitis.
• Limited efficacy compared to systemic agents, restricting use to less severe cases.

Patent and exclusivity

• Originally patent-protected through 2023.
• Pfizer filed for pediatric exclusivity to extend marketing rights.
• Patent expiration anticipated in 2024, opening generic alternatives potentially impacting pricing.

What is the forecasted financial trajectory?

Revenue projections

• U.S. sales expected to decline by 10-15% annually from 2023 to 2027 due to market saturation and emerging competitors.
• International markets projected to grow modestly at 3-5% annually, constrained by regulatory and reimbursement barriers.

Margin outlook

• Gross margins estimated around 70%, consistent with topical dermatological products.
• R&D expenses allocated toward expanding indications and formulation improvements.
• Operating margins likely to compress as sales decrease and competition intensifies.

Impact of patent expiration

• Generic entry forecasted in late 2023 or early 2024.
• Price erosion estimated at 30-50% based on historical trends in dermatology generics.
• Pfizer's revenue from Eucrisa could decline by up to 70% over five years post-patent expiry without new indications.

Strategic initiatives

• Developing extended-label formulations and combination therapies.
• Exploring new indications beyond atopic dermatitis.
• Licensing agreements or partnership with other biotech firms for market expansion.

How is the competitive landscape affecting Eucrisa?

Competitor	Key Product	Market Share (2022)	Notes
Dupixent (Sanofi/Regeneron)	Dupilumab	80% (eczema biologics)	Systemic biologic, significant efficacy, high price
Topical corticosteroids	Hydrocortisone, others	15% (topicals)	Widespread use, lower cost, less targeted
Emerging PDE4 inhibitors	Crisaborole biosimilars	Under development	Potentially lower-cost alternatives, regulatory hurdles

What are the key risks and opportunities?

Risks

• Patent expiry leading to generic competition.
• Price pressures from biosimilar and generic entrants.
• Limited efficacy restricts use to mild cases, limiting revenue potential.
• Regulatory delays or restrictions on new indications.

Opportunities

• Expansion into pediatric and adolescent populations.
• Development of combination therapies targeting multiple dermatological conditions.
• Market entry into emerging markets with growing dermatology needs.
• Potential for renewal of patent rights through new formulations or indications.

Key Takeaways

• Eucrisa's peak sales occurred in 2021, with revenue declining in 2022 and forecasted to decrease further post-patent expiration.
• Market share is under threat from systemic biologics like Dupixent and upcoming biosimilars.
• The company's ability to offset declining revenues depends on pipeline expansion and new indication development.
• Generic competition is expected to erode pricing and sales by late 2023 or early 2024.
• International expansion and formulation innovation remain strategic avenues for growth.

Frequently Asked Questions

1. When will Eucrisa face generic competition?
   Anticipated late 2023 or early 2024 upon patent expiration.

2. What is the primary driver of Eucrisa's revenue decline?
   Patent expiry leading to price erosion and increased generic competition.

3. Are there efforts to expand Eucrisa's indications?
   Pfizer is exploring formulations for other dermatological conditions and pediatric uses.

4. How does Eucrisa compare to systemic biologics?
   Eucrisa is targeted for mild to moderate cases; biologics like Dupixent are used for more severe cases with higher efficacy.

5. What strategic moves could sustain Eucrisa's market presence?
   Developing new formulations, expanding indications, and entering emerging markets.

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References

[1] Pfizer Inc. (2022). Eucrisa (crisaborole) U.S. Sales Data.
[2] IQVIA. (2022). Topical Dermatology Market Analysis.
[3] EvaluatePharma. (2023). Global Pharmaceutical Sales Database.
[4] U.S. Food and Drug Administration (FDA). (2017-2023). Approval and Regulatory Updates for Eucrisa.