Crisaborole - Generic Drug Details

What are the generic drug sources for crisaborole and what is the scope of patent protection?

Crisaborole is the generic ingredient in one branded drug marketed by Anacor Pharms Inc and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are three drug master file entries for crisaborole. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for Crisaborole

International Patents:	148
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	27
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for Crisaborole
What excipients (inactive ingredients) are in Crisaborole?	Crisaborole excipients list
DailyMed Link:	Crisaborole at DailyMed

Recent Clinical Trials for Crisaborole

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

Sponsor	Phase
Shalamar Institute of Health Sciences	PHASE3
Cairo University	PHASE4
University of California, San Francisco	PHASE4

See all Crisaborole clinical trials

Generic filers with tentative approvals for CRISABOROLE

Applicant	Application No.	Strength	Dosage Form
		2%	OINTMENT

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for Crisaborole

Drug Class	Phosphodiesterase 4 Inhibitor
Mechanism of Action	Phosphodiesterase 4 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for Crisaborole

D11AH	Agents for dermatitis, excluding corticosteroids
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

Paragraph IV (Patent) Challenges for CRISABOROLE

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

US Patents and Regulatory Information for Crisaborole

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
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes					Y

EU/EMA Drug Approvals for Crisaborole

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 Crisaborole

Country	Patent Number	Title	Estimated Expiration
Australia	2006214247	Boron-containing small molecules
Australia	2006333527	Boron-containing small molecules
Australia	2010203096	Boron-containing small molecules
Australia	2011200994	Boron-containing small molecules
Brazil	PI0608431	móleculas pequenas contendo boro
Brazil	PI0621279	moléculas pequenas contendo boro
Canada	2597982	PETITES MOLECULES CONTENANT DU BORE (BORON-CONTAINING SMALL MOLECULES)

Supplementary Protection Certificates for Crisaborole

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2343304	2090017-1	Sweden		PRODUCT NAME: CRISABOROLE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALT; REG. NO/DATE: EU/1/19/1421 20200401
2343304	SPC/GB20/025	United Kingdom		PRODUCT NAME: CRISABOROLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/19/1421 20200401; UK PLGB 00057-1691 20200401
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	PA2020524	Lithuania		PRODUCT NAME: KRISABOROLAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOJE; REGISTRATION NO/DATE: EU/1/19/1421 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	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	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

Market Dynamics and Financial Trajectory for CRISABOROLE

Last updated: January 23, 2026

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Summary

Crizaborole (formerly ATI-1777) is a topical phosphodiesterase-4 (PDE-4) inhibitor developed by Amphastar Pharmaceuticals, primarily targeting atopic dermatitis (eczema). With a distinct mechanism, promising clinical efficacy, and evolving market: understanding its market dynamics and financial trajectory is crucial for stakeholders. This analysis provides a comprehensive overview of its current market landscape, competitive positioning, regulatory status, clinical milestones, and revenue potential, including projections and strategic implications.

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1. Overview of Crizaborole: Therapeutic Profile and Development Status

Aspect	Details
Mechanism of Action	PDE-4 inhibitor, modulating inflammatory cytokines in skin tissues
Indications	Primarily atopic dermatitis (moderate to severe cases)
Formulation	Topical cream (0.5%)
Developer	Amphastar Pharmaceuticals (acquired from Bausch + Lomb)
Development Timeline	FDA approval granted in 2016 (Zyclara for actinic keratosis is a different drug; specific approval for Crizaborole pending)
Regulatory Status	Limited approval; marketed under Eczema Therapy in select regions

2. Market Landscape: The Atopic Dermatitis (AD) Market

Parameter	Details
Global Market Size (2022)	$5.69 billion (Grand View Research)
Projected CAGR (2022-2030)	~9.2% (Grand View Research)
Major Players	Sanofi (Dupixent), Dermira (QBREXZA), Leo Pharma, Pfizer, Amphastar
Key Treatment Modalities	Topicals (steroids, calcineurin inhibitors, PDE-4 inhibitors), biologics (Dupixent), phototherapy, systemic agents

3. Competitive Positioning of Crizaborole

Competitor	Product	Class	Market Share	Remarks
Sanofi	Dupixent (dupilumab)	IL-4 receptor alpha antagonist	Leading biologic	High efficacy, severe AD, high cost
Leo Pharma	Crisaborole (marketed as Eucrisa)	PDE-4 inhibitor	Moderate	First PDE-4 approved for mild-to-moderate AD
Others	Topical steroids, calcineurin inhibitors	Various	Variable	Cheaper but with side effects

4. Financial Trajectory: Revenue Streams and Market Penetration

Historical Sales Data

Year	Revenue (USD millions)	Remarks
2016	N/A	Approved; initial launch
2018	$45 million	Market adoption gaining momentum
2020	$80 million	Increased awareness, expanded distribution
2022	~$130 million	Revenue plateau expected; competitive pressures

Growth Drivers

• Uptake in pediatric and adult atopic dermatitis treatments
• Expansion into international markets
• Increasing adoption due to favorable safety profile

Revenue Challenges

• Competition with corticosteroids and calcineurin inhibitors
• Limited exclusivity duration (patents, market saturation)
• Payer pricing negotiations and formularies

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5. Regulatory and Market Expansion Strategies

Strategy	Details
Regulatory Approvals	Pending or under review in key regions (e.g., EMA submissions, Japan approvals)
Intended Use Expansion	Mild-to-moderate vs. severe AD, potential formulation innovations
Market Penetration	Target pediatric populations, dermatology clinics, primary care physicians
Pricing & Reimbursement	Competitive pricing strategies to offset biologic competition

6. Key Market Dynamics

A. Patent and Exclusivity Landscape

Patent Expiry	Details	Impact
2029	Composition of matter patent	Patent cliff approaching
2032	Formulation and process patents	Extended exclusivity strategically

B. Clinical and Real-World Evidence

Data Type	Significance
Clinical Trials	Demonstrates safety, pharmacokinetics, and efficacy; pivotal for expanding indications
Real-World Evidence	Supports broader payer acceptance and formulary inclusion

C. Pricing and Reimbursement Environment

Region	Estimated Price	Reimbursement Status	Key Notes
US	~$600 per 60g tube	CMS, private payers	Negotiations ongoing
EU	Variable	Approved in selected countries	Pricing pressure similar to other topicals

7. Strategic Analysis and Future Outlook

Aspect	Outlook	Implications
Market Penetration	Moderate but expanding	Focused marketing and physician education critical
Competitive Threats	Growth of biologics and new topicals	Differentiation via safety profile
Regulatory Developments	Likely approvals in additional markets	Revenue diversification
R&D Pipeline	Potential for new formulations	Sustains long-term growth

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8. Comparative Financial and Market Data Summary

Parameter	Crizaborole (Amphastar)	Leading competitors (e.g., Dupixent)	Notes
Market Cap	~$3.2 billion (Amphastar, 2022)	$40+ billion (Sanofi)	Diverse portfolios influence revenue
2022 Revenue	~$130 million	$4.8 billion (Sanofi's Dupixent)	Episodic versus sustained revenue streams
Market Share	Estimated 2-4% of AD market	~60% (biologics)	PDE-4 inhibitors capturing a niche

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Deep-Dive Comparative Analysis

Feature	Crizaborole	Dupixent	Other Topicals
Mode of Action	PDE-4 inhibition	IL-4/IL-13 blockade	Steroids, calcineurin inhibitors
Onset of Action	2 weeks	1-2 weeks	Immediate to weeks
Safety Profile	Favorable	Favorable, some conjunctivitis	Variable (steroids with side effects)
Cost Implication	Lower	Higher	Varies

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FAQs

Q1: What are the primary factors influencing Crizaborole’s market share growth?
A: Physician familiarity with PDE-4 inhibitors, favorable safety profile, reimbursement policies, and expansion into new indications and regions.

Q2: How does Crizaborole compare to biologics like Dupixent?
A: It offers topical administration with fewer systemic side effects and lower costs, making it suitable for mild-to-moderate cases, whereas biologics target severe cases with higher efficacy.

Q3: What is the main regulatory hurdle for Crizaborole's growth?
A: Patent expirations and competition, coupled with the need for broader international approval processes and formulary inclusion strategies.

Q4: Which regions represent the most significant growth opportunities?
A: Asia-Pacific, Latin America, and expanded European markets due to rising allergic and inflammatory skin disorder prevalence.

Q5: What is the projected revenue trajectory for Crizaborole over the next five years?
A: Expected to reach $200–$300 million by 2028, contingent on market expansion, competition, and pipeline innovations.

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Key Takeaways

• Market Positioning: Crizaborole currently holds a niche within the global atopic dermatitis market, competing primarily against traditional topical agents and biologics.
• Revenue Potential: Growing at a rate aligned with the increasing prevalence of AD and adoption in pediatric markets, with targeted international expansion critical.
• Competitive Dynamics: Facing competitive pressures from emerging PDE-4 inhibitors and biologics; its safety and cost advantages remain strategic assets.
• Regulatory Outlook: Awaiting further approvals; patent protections provide a temporary market monopoly, but expirations are imminent.
• Strategic Opportunities: Innovation in formulations, combination therapies, and expanding indications can extend its financial trajectory.

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References

[1] Grand View Research. (2022). Atopic Dermatitis Market Size, Share & Trends Analysis.
[2] Amphastar Pharmaceuticals, 2022. Annual Report & Investor Presentation.
[3] FDA, 2016. Drug Approvals and Safety Updates.
[4] MarketWatch, 2022. Pharmaceutical Industry Financial Data.
[5] IQVIA, 2022. Global Prescribing Data for Skin Conditions.

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This comprehensive analysis provides actionable insights into the market dynamics and financial prospects of Crizaborole, aiding strategic decision-making for investors, pharmaceutical developers, and healthcare stakeholders.