Crisaborole - Generic Drug Details

What are the generic sources for crisaborole and what is the scope of freedom to operate?

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.

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:	24
Patent Applications:	386
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
Sun Yat-sen University	Phase 2
University of Colorado, Denver	Phase 2
Boston University	Phase 4

See all crisaborole clinical trials

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
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

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/004863 Staquis 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
Russian Federation	2016145916	БОРСОДЕРЖАЩИЕ МАЛЫЕ МОЛЕКУЛЫ
Japan	6046876
Israel	192402	מולקולות קטנות המכילות בורון (Boron-containing small molecules)
Montenegro	02188	MALI MOLEKULI KOJI SADRŽE BORON KAO ANTIINFLAMATORNI AGENSI (BORON-CONTAINING SMALL MOLECULES AS ANTI-INFLAMMATORY AGENTS)

Supplementary Protection Certificates for crisaborole

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2343304	122020000038	Germany		PRODUCT NAME: CRISABOROL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON; REGISTRATION NO/DATE: EU/1/19/1421 20200327
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	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	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

Crisaborole Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Crisaborole

Introduction to Crisaborole

Crisaborole is a nonsteroidal topical phosphodiesterase 4 (PDE4) inhibitor, primarily used for the treatment of mild to moderate atopic dermatitis (also known as eczema). It is marketed under the brand name Eucrisa and has been gaining traction in the dermatological treatment market.

Market Size and Forecast

The crisaborole market is projected to experience significant growth from 2021 to 2031. According to market research, the market size is expected to increase at a Compound Annual Growth Rate (CAGR) of 3 to 5 percent, reaching an estimated valuation by 2031[1][4].

Segmentation of the Market

The crisaborole market is segmented based on several key factors:

• Application: The primary application is for allergic dermatitis, with other applications also being considered.
• Product: The market is segmented into products with purity above 98% and those with purity below 98%.
• Geography: The market is analyzed across regions including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[1][4].

Regional Market Dynamics

North America

North America is anticipated to be a leading region in the crisaborole market. This is driven by the high prevalence of atopic dermatitis and the presence of well-established healthcare infrastructure. The U.S. is expected to dominate this regional market due to adequate reimbursement coverage schemes for pharmaceutical companies[3].

Europe

Europe is also a significant market, supported by its well-established healthcare infrastructure. The region is expected to account for nearly one-third of the overall market share[3].

Asia-Pacific

The Asia-Pacific region, particularly China, is forecast to emerge as a highly remunerative market. This growth is attributed to the rising incidence of atopic dermatitis and other skin-related diseases in the region[3].

Key Drivers of Market Growth

• Increasing Incidence of Skin Ailments: The rising prevalence of atopic dermatitis and other skin conditions across North America and Asia-Pacific is a major driver of the market[3].
• Research and Development: Key manufacturers are heavily investing in research and development (R&D) activities to launch novel biologics and small molecule drugs, which is expected to boost market growth[3].
• High Convenience and Availability: The easy availability of therapeutic drugs and the rising number of pharmacies are driving sales, particularly through retail pharmacies[3].

Key Restraints

• High Cost of Treatment: The high cost of treatment for atopic dermatitis, especially in developing economies, is a significant restraint on market growth[3].
• Stringent Regulatory Approvals: The stringent regulatory approval scenario for novel atopic dermatitis therapeutics is another factor restraining market growth[3].

Financial Performance and Projections

The financial trajectory of the crisaborole market is positive, with steady growth anticipated over the forecast period. Here are some key financial insights:

• Revenue Growth: The market is expected to grow at a CAGR of 3 to 5 percent, indicating a steady increase in revenue over the years[1][4].
• Key Companies: Companies such as Tapi Teva, Neuraxpharm, Viruj Pharma, Synergy Pharmaceutical, and Ausun Pharmaceutical are profiled in market research reports, highlighting their contributions to the market's financial performance[1][4].

Competitive Landscape

The competitive landscape of the crisaborole market is characterized by several key players investing heavily in R&D to develop and commercialize new treatments. These companies are focused on providing innovative solutions for atopic dermatitis, which is driving market competition and growth.

Distribution Channels

Retail pharmacies are anticipated to lead the distribution channel segment, accounting for over three-fourths of atopic dermatitis drug sales. This is due to the high convenience and easy availability of therapeutic drugs through these channels[3].

Future Outlook

The future outlook for the crisaborole market is promising, driven by increasing demand for effective treatments for atopic dermatitis. As the prevalence of skin ailments continues to rise, the market is expected to expand significantly.

"Key manufacturers are heavily investing in research and development (R&D) activities for launching novel biologics and small molecule drugs for substituting first-line and second-line therapeutics. This is expected to bode well for the market growth," says a Fact.MR analyst[3].

Key Takeaways

• The crisaborole market is expected to grow at a CAGR of 3 to 5 percent from 2021 to 2031.
• North America and Europe are significant markets, with Asia-Pacific emerging as a highly remunerative region.
• The market is driven by the increasing incidence of skin ailments and investments in R&D.
• High treatment costs and stringent regulatory approvals are key restraints.
• Retail pharmacies dominate the distribution channel segment.

FAQs

What is crisaborole used for?

Crisaborole is primarily used for the treatment of mild to moderate atopic dermatitis (eczema).

Which regions are expected to lead the crisaborole market?

North America and Europe are expected to be leading regions, with Asia-Pacific, particularly China, emerging as a highly remunerative market.

What are the key drivers of the crisaborole market?

The key drivers include the increasing incidence of skin ailments, investments in R&D, and the high convenience and availability of therapeutic drugs.

What are the main restraints on the crisaborole market?

The main restraints are the high cost of treatment, especially in developing economies, and the stringent regulatory approval scenario for novel therapeutics.

Which distribution channels dominate the sales of crisaborole?

Retail pharmacies dominate the distribution channel segment, accounting for over three-fourths of atopic dermatitis drug sales.

Sources

1. Market Research Intellect - Global Crisaborole Market Size and Forecast[1].
2. Regeneron Pharmaceuticals INC - Form 10-K filed 02/06/2023[2].
3. Fact.MR - Sales Biologics Drugs for Atopic Dermatitis Treatment to Surpass US $15 Billion by 2027[3].
4. Market Research Intellect - Crisaborole Market Size And Forecast[4].