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 five 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.

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:	95
Clinical Trials:	16
Patent Applications:	142
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/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 EUCRISA

See the table below for patents covering EUCRISA around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	192402	מולקולות קטנות המכילות בורון (Boron-containing small molecules)
Israel	241792
Japan	6266708
Poland	2343304
South Korea	20150004937
South Korea	20130120552	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	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	20C1024	France		PRODUCT NAME: CRISABOROLE, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/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	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	PA2020524,C2343304	Lithuania		PRODUCT NAME: KRISABOROLAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOJE; REGISTRATION NO/DATE: EU/1/19/1421 20200327
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

Market Dynamics and Financial Trajectory for the Drug: EUCRISA

Introduction

EUCRISA, a phosphodiesterase 4 (PDE4) inhibitor, has been a significant player in the treatment of atopic dermatitis, also known as eczema. This article delves into the market dynamics and financial trajectory of EUCRISA, highlighting its current market size, growth potential, and the factors influencing its success.

Market Size and Growth Potential

The EUCRISA market is poised for substantial growth, driven by the increasing prevalence of atopic dermatitis globally. The market is expected to grow at a strong Compound Annual Growth Rate (CAGR) of around 6.5% during the forecast period of 2023-2030[1].

Prevalence of Atopic Dermatitis

Atopic dermatitis affects a significant portion of the population, with 1 in 5 children and 1 in 10 adults in the UK suffering from the condition. In the United States, an estimated 16.5 million adults have atopic dermatitis, with nearly 40% experiencing moderate or severe disease[1].

Driving Factors

Several factors are driving the growth of the EUCRISA market:

Increasing Product Launches

Pharmaceutical companies are actively launching new products to address the growing need for effective treatments for atopic dermatitis. This surge in product launches is a key driver for the market's expansion[1].

Research and Development

Rising research and development activities aimed at finding better treatments for eczema are also propelling the market forward. Global pharmaceutical giants are investing heavily in eczema drug discovery, which is expected to yield new and innovative treatments[1].

Government Initiatives

Government initiatives and regulatory support are further boosting the market. These initiatives focus on improving the diagnosis, treatment, and management of atopic dermatitis, thereby increasing the demand for drugs like EUCRISA[1].

Regional Market Dynamics

North America

North America dominated the EUCRISA market in 2022, driven by factors such as the availability of innovative products, growing awareness of skin diseases, and significant investment in eczema drug discovery. The region's strong healthcare infrastructure and high prevalence of atopic dermatitis also contribute to its market leadership[1].

Other Regions

While North America leads, other regions such as Europe, Asia Pacific, and the Rest of the World are also expected to contribute to the market's growth. Increasing healthcare spending and awareness about skin diseases in these regions will drive the demand for EUCRISA and other atopic dermatitis treatments[1].

Distribution Channels

The offline segment currently holds the largest share of the EUCRISA market by distribution channel. However, the online segment is expected to grow as digital healthcare platforms become more prevalent and accessible[1].

Emerging Trends and Technologies

Several clinical trials are underway to improve the treatment outcomes of EUCRISA. These trials aim to enhance the drug's efficacy and safety profile, which could further boost its market position. Additionally, the launch of late-stage emerging therapies for atopic dermatitis will shape the competitive landscape of the market[4].

Financial Performance

Current Market Size

The EUCRISA market was valued at USD XX Billion in 2022. The market is expected to grow significantly over the forecast period, driven by the factors mentioned above[1].

Revenue Projections

The market is projected to grow at a CAGR of 6.5% from 2023 to 2030. This growth will be fueled by increasing demand, new product launches, and expanding distribution channels[1].

Competitive Landscape

The EUCRISA market is highly competitive, with several pharmaceutical companies vying for market share. Pfizer, the manufacturer of EUCRISA, faces competition from other treatments and emerging therapies. The company's financial performance, as seen in its quarterly reports, reflects the broader trends in the pharmaceutical industry, including the impact of COVID-19-related products like Comirnaty and Paxlovid on overall revenues[2][5].

Regulatory Framework

EUCRISA has undergone rigorous clinical trials and has been approved by regulatory bodies such as the FDA. The drug's safety profile has been adequately characterized, with the most common adverse reaction being application site pain. Regulatory milestones and ongoing developmental activities continue to support the drug's market presence[3].

Value Chain Analysis

The value chain of the EUCRISA market involves various intermediaries, including manufacturers, distributors, and healthcare providers. Understanding customer and competitor behaviors is crucial for market players to sustain their position in the fast-growing market. The value chain analysis highlights the importance of efficient distribution channels and strong relationships with healthcare providers[1].

Company Profiles and Growth Strategies

Pfizer, the manufacturer of EUCRISA, has adopted several growth strategies to maintain its market position. These include significant investments in research and development, strategic partnerships, and expansion of distribution channels. The company's financial guidance and operational performance provide insights into its ability to navigate the competitive landscape[2][5].

Regional Level Analysis

A deep dive into regional level analysis reveals varying market dynamics across different regions. North America's dominance is attributed to its advanced healthcare infrastructure and high awareness of skin diseases. Other regions, however, present opportunities for growth as healthcare spending and awareness increase[1].

Key Takeaways

• The EUCRISA market is expected to grow at a CAGR of 6.5% from 2023 to 2030.
• Increasing product launches and research activities are driving the market.
• North America dominates the market due to advanced healthcare infrastructure and high prevalence of atopic dermatitis.
• The offline segment has the largest share of the market by distribution channel.
• Emerging trends include clinical trials to enhance treatment outcomes and the launch of new therapies.

FAQs

Q1: What is the current market size and growth potential of the EUCRISA market?

The EUCRISA market was valued at USD XX Billion in 2022 and is expected to grow at a CAGR of 6.5% during the forecast period (2023-2030)[1].

Q2: What are the driving factors for the growth of the EUCRISA market?

The driving factors include increasing product launches by pharmaceutical companies, rising research and development activities, and government initiatives to address atopic dermatitis[1].

Q3: Which segment has the largest share of the EUCRISA market by distribution channel?

The offline segment has the largest share of the EUCRISA market by distribution channel[1].

Q4: What are the emerging trends in the EUCRISA market?

Emerging trends include several clinical trials to improve treatment outcomes and the launch of late-stage emerging therapies for atopic dermatitis[4].

Q5: Which region will dominate the EUCRISA market during the forecast period?

North America is expected to dominate the EUCRISA market during the forecast period due to its advanced healthcare infrastructure and high prevalence of atopic dermatitis[1].

Sources

1. UnivDatos Market Insights: EUCRISA Market: Current Analysis and Forecast (2023-2030)
2. Pfizer: Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Guidance
3. FDA: Clinical Review and Evaluation - EUCRISA™ (crisaborole) ointment, 2%
4. Research and Markets: EUCRISA Market Drug Insight and Market Forecast - 2032
5. Pfizer: Pfizer Reports Fourth-Quarter and Full-Year 2021 Results and Provides Full-Year 2022 Guidance