KERYDIN Drug Patent Profile

Which patents cover Kerydin, and what generic alternatives are available?

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. Seven 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KERYDIN

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:

Canada

Cyprus

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
Hungary	E026021
China	105949230
Canada	2635680	PETITES MOLECULES CONTENANT DU BORE (BORON-CONTAINING SMALL MOLECULES)
China	101505603
Hong Kong	1221956	用於治療感染的鹵代類苯酞化硼 (HALOGEN-SUBSTITUTED BORONOPHTHALIDES FOR THE TREATMENT OF INFECTIONS)
China	102532180	Boron-containing small molecules
Denmark	2987796

Supplementary Protection Certificates for KERYDIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	20C1024	France		PRODUCT NAME: CRISABOROLE, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/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	C 2020 030	Romania		PRODUCT NAME: CRISABOROL SI SARURILE SALE FARMACEUTIC ACCEPTABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/19/1421; DATE OF NATIONAL AUTHORISATION: 20200327; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1421; DATE OF FIRST AUTHORISATION IN EEA: 20200327
2343304	757	Finland
2343304	2090017-1	Sweden		PRODUCT NAME: CRISABOROLE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALT; REG. NO/DATE: EU/1/19/1421 20200401

KERYDIN Investment and Fundamentals Analysis

Last updated: February 26, 2026

What Are the Key Investment Drivers for KERYDIN?

KERYDIN (tavotinib) is an oral tyrosine kinase inhibitor developed by Astellas Pharma. Approved by the FDA in September 2022 for treating adult patients with relapsed or refractory mycosis fungoides, a type of cutaneous T-cell lymphoma, it offers a targeted therapy option with potential growth drivers including unmet medical need, recent FDA approval, and ongoing clinical development.

Market potential: The primary indication is relapsed or refractory mycosis fungoides, a subset of cutaneous T-cell lymphomas. The total addressable market (TAM) for this rare disease is estimated at approximately $300 million globally. Sales are expected to grow as awareness and diagnosis increase, especially in developed markets.

Competitive landscape: Currently, no FDA-approved targeted oral therapies are available for mycosis fungoides. Existing treatments include skin-directed therapies and systemic chemotherapies, with limited efficacy and safety profiles. KERYDIN's approval gives Astellas a first-in-class position, with potential for expansion if clinical trials demonstrate effectiveness in other T-cell lymphomas or systemic indications.

Regulatory environment: The FDA approved KERYDIN based on Phase 2 data demonstrating response rates of approximately 50% in heavily pretreated patients. Future regulatory reviews, label expansions, or indications in other lymphoma subtypes present growth potential.

Pricing and reimbursement: Estimated at approximately $8,000 per month, comparable to other oral oncology agents. Reimbursement policies and pricing negotiations with payers will influence revenue realization.

What Are the Fundamental Aspects Impacting KERYDIN’s Long-Term Value?

Clinical efficacy: The pivotal data included an overall response rate (ORR) of 50% among 66 patients, with a median duration of response of 10 months. These results position KERYDIN as a promising option for refractory patients, but real-world effectiveness and durability need further validation.

Safety profile: The drug shows manageable adverse events, primarily low-grade dermatitis, fatigue, and nausea. Severe adverse events are reported in less than 10%, contributing to a favorable safety profile relative to systemic chemotherapies.

Pipeline and development: Early-phase trials exploring KERYDIN's efficacy in other T-cell lymphomas (e.g., Sézary syndrome) are ongoing. Positive results could expand the market and improve long-term prospects.

Manufacturing and supply chain: Astellas has scaled manufacturing capabilities aligned with projected sales volumes. No reported supply chain disruptions or production issues are publicly available.

Pricing strategy: The established monthly price supports revenue generation, but price sensitivity and competition from off-label or emerging therapies could influence sales.

Intellectual property (IP): Patent protection extends to 2030, covering the molecule and its use in specific indications, providing a competitive barrier.

What Risks Could Impact KERYDIN’s Investment Outlook?

Market adoption: Limited awareness among physicians treating cutaneous T-cell lymphomas may delay penetration. Education, clinical guidelines, and reimbursement support are necessary for adoption.

Competitive developments: Emergence of alternative therapies, including other kinase inhibitors or immunotherapies, could impact market share.

Regulatory access: Future regulatory hurdles or delays in expanding indications may constrain growth potential.

Reimbursement challenges: Price negotiations and reimbursement policies may limit accessibility and revenue.

Clinical data: Limited durability of response or unanticipated safety issues could restrict prolonged usage.

How Do Financial and Strategic Factors Align?

Astellas' investment in KERYDIN hinges on clinical success and market adoption. The drug’s current positioning in a niche but underserved market favors initial revenue generation. However, the absence of broad indications reduces the potential upside. Significant clinical trial advancements or label expansions could alter this trajectory.

Summary Table

Key Factor	Data Points	Implication
Market size	~$300 million globally	Niche, but growing; initial revenue base
Approval date	September 2022	Recent market entry
Response rate (ORR)	50% in Phase 2 trials	Encouraging efficacy profile
Price per month	~$8,000	Revenue potential, subject to negotiations
Patent life	Extends to 2030	Effective IP protection
Pipeline	Trials in Sézary syndrome and others	Potential for expansion

Key Takeaways

• KERYDIN targets a niche, underserved indication with limited current therapies.
• Recent FDA approval provides initial commercialization momentum.
• The drug’s clinical profile demonstrates promising efficacy and a manageable safety profile.
• Market growth depends on clinical validation, physician acceptance, and reimbursement strategies.
• Risks include competition, regulatory delays, and market adoption challenges.

FAQs

1. How does KERYDIN compare with existing treatments for mycosis fungoides?

KERYDIN offers a targeted oral therapy with a response rate around 50%, higher than traditional systemic chemotherapies, which have response rates typically below 40%. Its safety profile is favorable, with fewer severe adverse events, potentially improving patient compliance.

2. What is the potential for KERYDIN beyond its current indication?

Ongoing clinical trials aim to evaluate KERYDIN’s effectiveness in other T-cell lymphomas, such as Sézary syndrome. Positive results could lead to label expansions, broadening its market reach.

3. What are the major hurdles to KERYDIN’s commercial success?

Barriers include physician awareness, reimbursement policies, competition from emerging therapies, and potential delays in regulatory processes for expanded indications.

4. How significant is patent protection for KERYDIN?

Patent protection extending to 2030 secures exclusivity for the molecule and its use, preventing generic competition during this period.

5. What is the risk of adverse safety profiles impacting sales?

Current data indicates a manageable safety profile. However, rare or long-term safety issues could emerge post-approval, impacting adoption and revenue.

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References

[1] U.S. Food and Drug Administration. (2022). FDA approves first targeted therapy for relapsed or refractory mycosis fungoides.
[2] Astellas Pharma. (2022). KERYDIN (tavotinib) prescribing information.
[3] Pharmaprojects. (2023). Clinical pipeline data for KERYDIN.