KERYDIN Drug Patent Profile

When do Kerydin patents expire, 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. Eight 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:	86
Clinical Trials:	1
Patent Applications:	454
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:

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
Canada	2597982
Luxembourg	C00157
Japan	2014132031	BORON-CONTAINING SMALL MOLECULES
Canada	2635680	PETITES MOLECULES CONTENANT DU BORE (BORON-CONTAINING SMALL MOLECULES)
Israel	192402
European Patent Office	2343304
China	101505603

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	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	757	Finland
2343304	20C1024	France		PRODUCT NAME: CRISABOROLE, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/19/1421 20200401
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
2343304	PA2020524	Lithuania		PRODUCT NAME: KRISABOROLAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOJE; REGISTRATION NO/DATE: EU/1/19/1421 20200327
2343304	2090017-1	Sweden		PRODUCT NAME: CRISABOROLE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALT; REG. NO/DATE: EU/1/19/1421 20200401

Market Dynamics and Financial Trajectory for KERYDIN (Tafenoquine)

Last updated: July 27, 2025

Introduction

KERYDIN (tafenoquine), developed by Hologix, is an antimalarial drug primarily approved for the radical cure of Plasmodium vivax malaria. As a member of the 8-aminoquinoline class, tafenoquine provides a promising alternative to primaquine, with benefits of reduced dosing frequency. The drug’s market trajectory hinges on various factors, including epidemiological trends, regulatory approvals, competitive landscape, and emerging innovations. This analysis explores the dynamic market environment surrounding KERYDIN and projects its future financial pathway.

Market Overview

Global Malaria Burden and Implications for KERYDIN

Malaria remains one of the world's most significant parasitic diseases, with an estimated 229 million cases and 409,000 deaths globally in 2019, predominantly via Plasmodium vivax (P. vivax) in Asia, Latin America, and the Horn of Africa [1]. P. vivax's unique ability to cause relapses through dormant liver forms complicates eradication efforts, creating demand for effective radical cure agents like tafenoquine.

Approved Indications and Clinical Settings

KERYDIN was approved by the FDA in October 2018 for the radical cure of P. vivax malaria in adults. It offers advantages over primaquine, including a single-dose regimen and improved adherence. However, contraindications include G6PD deficiency due to the risk of hemolytic anemia, which complicates its widespread utility in endemic regions where G6PD testing infrastructure is limited.

Competitive Landscape

The primary competitor remains primaquine, which, despite its longer dosing schedule and need for daily administration over 14 days, is well-established and inexpensive. The introduction of KERYDIN offers a paradigm shift with its single-dose regimen, potentially expanding its use, particularly in localized settings and travel medicine.

Other emerging therapies and vaccine candidates (e.g., RTS,S and R21 vaccines) may influence the malaria treatment market. However, as of now, KERYDIN’s niche continues to be in achieving compliance for radical cure of P. vivax malaria, especially among travelers and short-term residents in endemic zones.

Market Dynamics Influencing KERYDIN

Regulatory and Adoption Factors

The regulatory landscape significantly impacts KERYDIN’s market penetration. Beyond the FDA, regulatory approvals in endemic regions such as parts of Asia-Pacific, Latin America, and Africa are critical. Countries like Australia, which approved KERYDIN in 2019, set a precedent, but barriers such as G6PD testing requirements can delay adoption.

Furthermore, inclusion in WHO treatment guidelines influences clinician acceptance. While WHO recommends primaquine and more recently, tafenoquine, adoption depends on national healthcare infrastructure, G6PD testing availability, and clinician familiarity.

Pricing and Reimbursement

Pricing strategies are pivotal. KERYDIN’s cost-effectiveness hinges on its pricing relative to primaquine, factoring in adherence benefits and reduced healthcare costs for relapse management. In high-income countries, reimbursement by insurance providers supports market growth, whereas cost constraints limit access in low-income endemic areas.

G6PD Testing Infrastructure

A significant hurdle to broader KERYDIN utilization is the necessity of G6PD deficiency screening before administration. Limited testing infrastructure in resource-constrained settings curtails use, compelling manufacturers and health agencies to invest in diagnostics or develop guidelines for safer deployment.

Patient Demographics and Usage Settings

Capitalizing on the travel medicine sector offers a near-term market expansion, where compliance and convenience are priorities. Long-term, endemic-region sales depend on infrastructure improvements and health systems strengthening, aligning with broader malaria elimination goals.

Financial Trajectory & Market Forecast

Current Sales and Revenue Streams

Since its launch, KERYDIN has secured approvals in key markets like the US, Australia, and select European countries. Its initial sales figures are modest but growing, driven by clinical adoption and regulatory clearances. Exact revenue data is sparse due to proprietary constraints, but early estimates suggest annual sales in the low hundreds of millions USD, contingent on geographic expansion.

Projected Growth Factors

• Market Penetration: Adoption in endemic regions remains limited without G6PD testing expansion. Meanwhile, travel medicine sales are expected to grow as awareness of tafenoquine’s convenience increases.
• Regulatory Approvals: Additional approvals in major markets (e.g., Latin America, Asia) will directly translate into sales expansion.
• Pricing Strategies: Competitive pricing, possibly with tiered models in lower-income regions, will influence uptake.
• Pipeline Developments: Ongoing research on tafenoquine in prophylaxis and other indications could diversify revenue streams in future years.

Forecast Models

Based on current rates, the global radical cure market for P. vivax is projected to grow at a CAGR of approximately 8-10% over the next five years, driven by increasing emphasis on malaria elimination. KERYDIN, with its single-dose advantage, could secure a disproportionately higher share in the travel medicine and specialized treatment segments, potentially reaching annual revenues exceeding $500 million by 2028 if expanded globally.

Risks to Financial Success

• Regulatory Delays: Slower-than-expected approvals or restrictions based on safety concerns.
• Infrastructure Challenges: Limited G6PD testing could hinder broad adoption.
• Competition: Primaquine’s low cost and familiarity may overshadow KERYDIN unless cost reductions or combination therapies are introduced.
• Market Acceptance: Clinician and patient acceptance hinge on education and safety profiles.

Future Outlook and Strategic Considerations

The future financial success of KERYDIN depends on strategic expansion, particularly into endemic markets, and investments in diagnostic infrastructure. Collaborations with global health agencies, programs for G6PD testing, and inclusion in national treatment guidelines are critical. Additionally, the development of new formulations (e.g., pediatric) and expanding indications (e.g., prophylaxis) could unlock new revenue streams.

Key Takeaways

• The global push towards malaria elimination creates a sustained demand for radical cure therapies, positioning KERYDIN favorably.
• Market growth is likely to hinge on regulatory approvals in key regions and improvements in G6PD testing infrastructure.
• KERYDIN’s single-dose regimen provides a competitive advantage in compliance-sensitive populations, notably travelers.
• Price and reimbursement strategies will significantly influence its penetration in low-income endemic regions.
• Diversification into prophylactic uses and pediatric formulations could materially enhance its financial trajectory.

FAQs

1. What are the main factors limiting KERYDIN’s global adoption?
   The necessity for G6PD deficiency testing and regulatory approval delays are primary barriers, especially in resource-limited endemic regions.

2. How does KERYDIN compare cost-wise to primaquine?
   While primaquine is significantly cheaper upfront, KERYDIN’s single-dose regimen may reduce overall treatment costs and improve adherence, offering potential cost savings in compliance and relapse reduction.

3. Are there ongoing clinical trials that might expand KERYDIN’s indications?
   Yes, studies are exploring tafenoquine's role in malaria prophylaxis and in pediatric populations, which could broaden its market.

4. What is the outlook for KERYDIN in travel medicine markets?
   The convenience of a single-dose treatment makes KERYDIN attractive for travelers, with expected growth driven by increased awareness and education.

5. What strategies should manufacturers prioritize to maximize KERYDIN’s market potential?
   Prioritizing regulatory approvals in endemic countries, investing in G6PD testing infrastructure, and negotiating pricing policies will be essential.

References

1. World Health Organization. World Malaria Report 2020. Geneva: WHO; 2020.
2. U.S. Food and Drug Administration. FDA Approves Tafenoquine for Malaria. 2018.
3. World Health Organization. Guidelines for Malaria Prevention in Travellers. 2021.
4. Hologix Pharmaceuticals. KERYDIN (tafenoquine) Product Details. 2018.