KERYDIN Drug Patent Profile

Which patents cover Kerydin, and when can generic versions of Kerydin launch?

Kerydin is a drug marketed by Anacor Pharms Inc and is included in one NDA.

The generic ingredient in KERYDIN is tavaborole. There are six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the tavaborole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Kerydin

A generic version of KERYDIN was approved as tavaborole by ENCUBE on October 13^th, 2020.

Summary for KERYDIN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	1
Patent Applications:	222
Drug Prices:	Drug price information for KERYDIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KERYDIN
What excipients (inactive ingredients) are in KERYDIN?	KERYDIN excipients list
DailyMed Link:	KERYDIN at DailyMed

See drug prices for KERYDIN

Recent Clinical Trials for KERYDIN

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

Sponsor	Phase
Pfizer	Phase 4

See all KERYDIN clinical trials

Paragraph IV (Patent) Challenges for KERYDIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KERYDIN	Topical Solution	tavaborole	5%	204427	13	2018-07-09

US Patents and Regulatory Information for KERYDIN

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	KERYDIN	tavaborole	SOLUTION;TOPICAL	204427-001	Jul 7, 2014		DISCN	Yes	No

International Patents for KERYDIN

When does loss-of-exclusivity occur for KERYDIN?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Mexico

Netherlands

New Zealand

Poland

Portugal

Russian Federation

Slovenia

South Africa

South Korea

Spain

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 KERYDIN around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	3424932
Poland	1853251
European Patent Office	2987796	BORONOPHTHALIDES SUBSTITUES PAR HALOGENE POUR LE TRAITEMENT D'INFECTIONS (HALOGEN-SUBSTITUTED BORONOPHTHALIDES FOR THE TREATMENT OF INFECTIONS)
European Patent Office	3424932	BORONOPHTHALIDES À USAGE THÉRAPEUTIQUE (BORONOPHTHALIDES FOR THERAPEUTIC USE)
Cyprus	1124503
New Zealand	598441	BORON-CONTAINING SMALL MOLECULES

Supplementary Protection Certificates for KERYDIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	122020000038	Germany		PRODUCT NAME: CRISABOROL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON; REGISTRATION NO/DATE: EU/1/19/1421 20200327
2343304	C20200027 00352	Estonia		PRODUCT NAME: KRISABOROOL;REG NO/DATE: EU/1/19/1421 01.04.2020
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

KERYDIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for KERYDIN

Introduction to KERYDIN

KERYDIN, also known as tavaborole, is a topical antifungal medication used for the treatment of dermatophytic onychomycosis, a fungal infection of the toenails. It is one of the key players in the dermatophytic onychomycosis treatment market, particularly notable for its efficacy and safety profile.

Market Position and Competitive Landscape

Market Share and Competitors

KERYDIN, developed by Anacor Pharmaceuticals (now part of Pfizer), holds a significant position in the market. However, its market share is second to Bausch Health's Jublia, which dominates the market due to its higher sales and favorable reimbursement policies. Despite this, KERYDIN remains a crucial player, driven by increasing demand and its inclusion in treatment protocols for onychomycosis[4].

Key Players and Strategic Moves

Pfizer's acquisition of Anacor Pharmaceuticals in 2016 marked a significant strategic move, enhancing Pfizer's Inflammation and Immunology portfolio. This acquisition was expected to boost near-term revenue growth for Pfizer's innovative business segment[5].

Financial Performance

Revenue and Sales

KERYDIN has contributed substantially to the revenue of its parent companies. In 2015, Anacor Pharmaceuticals reported $69.7 million in revenue from distribution and commercialization agreements, which included significant contributions from KERYDIN sales. The cost of goods sold for KERYDIN in 2015 was $4.0 million, indicating growing product sales[2].

Cost of Goods Sold and Research Expenses

The cost of goods sold for KERYDIN increased from $0.8 million in 2014 to $4.0 million in 2015, reflecting increased product sales. Research and development expenses related to KERYDIN were also significant, with $73.9 million spent in 2015, although this figure includes costs from various other projects as well[2].

Market Drivers and Growth Factors

Rising Prevalence of Onychomycosis

The growing prevalence of onychomycosis, affecting around 10% of the global population and approximately 35-40 million Americans, drives the demand for treatments like KERYDIN. This increasing incidence is a major factor contributing to the market growth[1].

Preference for Topical Treatments

There is a growing preference for topical treatments over oral antifungals due to the potential side effects associated with oral medications. This trend favors KERYDIN, as it is a topical solution with a lower risk of systemic side effects compared to oral terbinafine[1].

Regulatory Approvals and New Drug Applications

Regulatory approvals, such as the U.S. FDA's approval of supplemental new drug applications for similar treatments, enhance market confidence and drive growth. Although KERYDIN itself has been on the market for some time, such approvals set a positive precedent for other topical treatments[4].

Challenges and Limitations

Side Effects and Safety Concerns

While KERYDIN is generally well-tolerated, potential side effects can impact its market growth. Common side effects include application site exfoliation, ingrown toenail, application site erythema, and application site dermatitis. These side effects, although mild, can influence patient and physician preferences[4].

Economic and Regulatory Challenges

The economic crisis caused by the COVID-19 pandemic has affected the market share of KERYDIN and other treatments. Additionally, regulatory hurdles and the stringent safety and efficacy requirements for new drug formulations can slow market progress[4].

Regional Market Analysis

North America

North America, particularly the U.S., is a dominant region for the dermatophytic onychomycosis treatment market, including KERYDIN. The region benefits from advanced healthcare infrastructure, significant R&D investments, and a high number of prescriptions for onychomycosis treatments. The total number of annual prescriptions for onychomycosis in North America is around 5 million, which significantly drives the market growth[4].

Other Regions

While North America leads, other regions such as Europe and the Asia Pacific are also experiencing growth. The Asia Pacific region is particularly noteworthy for its high market growth rate, driven by advancing healthcare services and increasing awareness campaigns[1].

Future Outlook

Technological Innovations and R&D

Investments in research and development for advanced treatments are expected to drive market demand. Innovations in topical drug delivery systems, such as improved formulations and delivery mechanisms, will continue to enhance the market for KERYDIN and similar treatments[3].

Online Pharmacies and Distribution Channels

The increasing preference for online pharmacies post-COVID-19 is expected to provide remarkable growth opportunities for KERYDIN. Benefits such as convenience, discounts, and no waiting lines are likely to shift more patients towards online channels, bolstering the segment growth[4].

Key Takeaways

• Market Position: KERYDIN holds a significant position in the dermatophytic onychomycosis treatment market, though it is second to Jublia in terms of market share.
• Financial Performance: KERYDIN has contributed substantially to the revenue of its parent companies, with increasing sales and costs of goods sold.
• Market Drivers: The growing prevalence of onychomycosis, preference for topical treatments, and regulatory approvals drive the market growth.
• Challenges: Side effects, economic crises, and regulatory hurdles are key challenges.
• Regional Analysis: North America is the dominant region, with other regions also experiencing growth.
• Future Outlook: Technological innovations and the rise of online pharmacies are expected to drive future growth.

FAQs

What is KERYDIN used for?

KERYDIN, or tavaborole, is a topical antifungal medication used for the treatment of dermatophytic onychomycosis, a fungal infection of the toenails.

Who are the key players in the market for KERYDIN?

The key players include Pfizer (which acquired Anacor Pharmaceuticals) and Bausch Health, with Bausch Health's Jublia being the market leader.

What are the main drivers of the market for KERYDIN?

The main drivers include the rising prevalence of onychomycosis, a growing preference for topical treatments, and regulatory approvals.

What are the challenges faced by KERYDIN in the market?

Challenges include potential side effects, economic crises such as those caused by the COVID-19 pandemic, and regulatory hurdles.

How is the market for KERYDIN expected to grow in the future?

The market is expected to grow driven by technological innovations in topical drug delivery systems and the increasing use of online pharmacies.

Which region dominates the market for KERYDIN?

North America, particularly the U.S., dominates the market due to advanced healthcare infrastructure and a high number of prescriptions for onychomycosis treatments.

Sources

1. Market.us: Dermatophytic Onychomycosis Treatment Market CAGR Of 8.46%[1]
2. Businesswire: Anacor Pharmaceuticals Reports 2015 Fourth Quarter and Year-End Financial Results[2]
3. Globenewswire: Topical Drug Delivery Market is expected to generate a revenue of USD 177.97 Billion by 2031[3]
4. Fortune Business Insights: Dermatophytic Onychomycosis Treatment Market Size [2032][4]
5. Pfizer: Pfizer to Acquire Anacor[5]