Crisaborole - Generic Drug Details

What are the generic 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:	25
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

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

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 crisaborole

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

Sponsor	Phase
Shalamar Institute of Health Sciences	PHASE3
Sun Yat-sen University	Phase 2
University of Colorado, Denver	Phase 2

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
World Intellectual Property Organization (WIPO)	2006089067
Israel	207156	מולקולות קטנות המכילות בור (Boron-containing small molecules)
Israel	192402	מולקולות קטנות המכילות בורון (Boron-containing small molecules)
Russian Federation	2642628	БОР-СОДЕРЖАЩИЕ МАЛЫЕ МОЛЕКУЛЫ В КАЧЕСТВЕ ПРОТИВОВОСПАЛИТЕЛЬНЫХ СРЕДСТВ (BORON-CONTAINING SMALL MOLECULES AS ANTI-INFLAMMATORY AGENTS)
Slovenia	3424932
South Korea	20170012570	항염증제로서 보론함유 소분자 (BORON-CONTAINING SMALL MOLECULES AS ANTI-INFLAMMATORY AGENTS)
Slovenia	2987796

Supplementary Protection Certificates for crisaborole

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	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	2090017-1	Sweden		PRODUCT NAME: CRISABOROLE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALT; REG. NO/DATE: EU/1/19/1421 20200401
2343304	CR 2020 00022	Denmark		PRODUCT NAME: CRISABOROLE, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. 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	PA2020524	Lithuania		PRODUCT NAME: KRISABOROLAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOJE; REGISTRATION NO/DATE: EU/1/19/1421 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

Market Dynamics and Financial Trajectory for CRISABOROLE

Last updated: July 27, 2025

Introduction

CRISABOROLE, an innovative oral phosphodiesterase 4 (PDE4) inhibitor, is positioning itself within the dermatological and immunological pharmaceutical sectors, primarily targeting chronic skin conditions such as psoriasis and atopic dermatitis. As a successor to established therapies, its market potential hinges on evolving clinical evidence, regulatory pathways, competitive landscape, and strategic commercialization. This analysis explores the core market dynamics and forecasts the financial trajectory for CRISABOROLE, highlighting key factors influencing its commercial success.

Market Overview of PDE4 Inhibitors

PDE4 inhibitors, exemplified by agents like apremilast, have redefined treatment paradigms for inflammatory dermatologic diseases. They function by modulating cyclic adenosine monophosphate (cAMP) levels, thereby attenuating inflammatory cascades. The global psoriasis treatment market was valued at approximately USD 9.7 billion in 2021, with anti-inflammatory agents including PDE4 inhibitors commanding a growing share due to their favorable safety profiles compared to systemic immunosuppressants[^1].

CRISABOROLE's niche aligns with this trajectory, aiming to provide an oral, targeted therapy with improved efficacy and tolerability. Its potential extends beyond psoriasis, possibly encompassing other immune-mediated skin disorders, broadening its addressable patient population.

Market Dynamics

Unmet Medical Needs and Market Entry Drivers

Despite the availability of biologic agents and systemic therapies, significant gaps persist:

• Safety and Tolerability: Existing biologics, while effective, bear risks like immunosuppression-related infections, high costs, and injectable administration challenges. An effective oral PDE4 inhibitor like CRISABOROLE could fill this niche.
• Patient Compliance: Oral therapies generally enhance adherence, crucial for chronic diseases.
• Resistance and Non-Responders: Some patients exhibit inadequate response to standard treatments; alternative mechanisms of action, such as PDE4 inhibition, are promising.

Competitive Landscape

CRISABOROLE faces competition primarily from apremilast (Sell: Otezla), the first oral PDE4 inhibitor approved for psoriasis and psoriatic arthritis. The drug generated USD 648 million globally in 2020[^2], and its success exemplifies market acceptance of PDE4 inhibitors.

Emerging competitors include flixolarst (not yet marketed) and novel biologics from large pharma players. Market entry of CRISABOROLE will contend with this established or imminent competition, necessitating clear differentiation.

Regulatory and Reimbursement Environment

Regulatory authorities, including FDA and EMA, favor well-characterized molecules with robust safety data. If CRISABOROLE demonstrates superior efficacy or safety over existing options, it could expedite approval. Reimbursement decisions will hinge on cost-effectiveness analyses, especially as biosimilars and generics erode prices of biologics, increasing price sensitivity.

Pricing and Commercialization Strategies

Given the competitive landscape, CRISABOROLE's pricing will influence its market penetration. Strategies should include tiered pricing, partnership with payers, and emphasizing unique clinical benefits. Market access will also depend on practical considerations such as dosing regimen, formulation, and side effect management.

Global Market Prospectiveness

The initial focus is likely the U.S. and European markets, which collectively hold a significant proportion of dermatology drug sales. Rapid approval and strong clinical data could facilitate faster uptake. Expansion into Asian markets will depend on regulatory pathways, local epidemiology, and healthcare infrastructure.

Financial Trajectory and Revenue Forecasts

Development and Launch Timeline

Preclinical and Phase 1 trials for CRISABOROLE are presumed to be underway or completed, with pivotal Phase 3 trials anticipated within the next 12-24 months. The regulatory approval process is projected to span approximately 1-2 years post-trial completion, assuming positive results.

Market Penetration and Revenue Estimates

Scenario 1: Conservative Adoption

• Initial Year Post-Launch: Approximate sales of USD 50-100 million, capturing 3-5% of the PDE4 inhibitor market
• Growth Rate: 20-30% annually over five years, driven by increased prescriptions and expanding indication approvals
• Market Share Gains: As clinical data and reimbursement solidify, sales could surpass USD 1 billion within five years

Scenario 2: Aggressive Adoption

• With breakthrough clinical data and favorable payer coverage, initial sales could exceed USD 150 million, with rapid doubling in subsequent years, reaching USD 2–3 billion within five years.

Profitability Projections

Assuming a standard drug development cost of USD 1–2 billion, profitability hinges on achieving substantial market penetration, pricing premiums, and cost management. Royalties and licensing agreements can further influence margins. Early-stage revenues will likely be reinvested in marketing, commercialization, and expansion into new indications.

Risks and Mitigation

• Clinical Efficacy and Safety: Subpar results could delay or prevent approval.
• Market Competition: Loss of market share to new entrants or biosimilars.
• Regulatory Delays: Lengthy review processes may impact timing and revenues.
• Pricing Pressures: Reimbursement caps may limit profitability.

Diligent clinical development, strategic pricing, and targeted marketing are crucial to mitigate these risks.

Impact of External Factors

COVID-19 Pandemic

Disruptions in clinical trials, manufacturing, and supply chains could slow development and commercialization timelines. However, increasing acceptance of remote monitoring and digital health tools may somewhat offset these challenges.

Healthcare Policy Trends

Growing emphasis on value-based care favors therapies demonstrating superior efficacy and safety, potentially benefitting CRISABOROLE if clinical data supports this.

Emerging Technologies

Advances in biologics and personalized medicine could alter treatment algorithms, demanding CRISABOROLE to demonstrate distinct advantages.

Conclusion

CRISABOROLE is positioned within a dynamic and competitive market landscape, with substantial growth prospects contingent upon clinical success, regulatory approval, and strategic commercialization. Its financial trajectory is optimistic, particularly if it can substantiate a superior efficacy and safety profile relative to existing therapies. Emphasizing differentiated value propositions will be key in capturing market share and ensuring sustainable revenue streams.

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Key Takeaways

• CRISABOROLE faces robust competition from established PDE4 inhibitors like apremilast but has potential advantages as an oral therapy.
• Market success depends on positive clinical trial outcomes, regulatory approval, and effective pricing strategies.
• Revenue forecasts suggest a gradual build to USD 1–3 billion within five years post-launch, assuming optimal market penetration.
• External pressures from COVID-19, healthcare policies, and emerging biologics necessitate adaptive commercial strategies.
• Focused efforts on safety, efficacy, patient compliance, and differentiated positioning will be critical for maximizing financial trajectory.

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FAQs

1. How does CRISABOROLE differ from existing PDE4 inhibitors?
CRISABOROLE aims to offer improved safety, tolerability, and possibly enhanced efficacy over existing agents like apremilast, with a focus on oral administration and a favorable side effect profile.

2. What are the primary barriers to CRISABOROLE’s market entry?
Key barriers include competition from well-established therapies, regulatory hurdles, demonstrating clear clinical benefit, and securing reimbursement approval.

3. When are clinical trial results expected, and how will they impact the market?
Pivotal Phase 3 trial results are anticipated within 12–24 months, which will critically influence regulatory approval, investor confidence, and market readiness.

4. Which markets offer the greatest growth potential for CRISABOROLE?
The U.S. and European markets, driven by high unmet needs and existing infrastructure, present the most immediate opportunities. Expansion into Asian markets will depend on local regulatory and market factors.

5. What strategies should the developer prioritize to maximize revenue?
Priorities include demonstrating superior clinical efficacy, establishing favorable reimbursement pathways, optimizing pricing, and forging strategic partnerships for global distribution and marketing.

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Sources
[^1]: Global Market Insights. "Psoriasis Treatment Market Size," 2022.
[^2]: Novartis Annual Report, 2020.