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
Hong Kong	1109735
China	101914109	Boron-containing small molecules
European Patent Office	3424932	BORONOPHTHALIDES À USAGE THÉRAPEUTIQUE (BORONOPHTHALIDES FOR THERAPEUTIC USE)
Netherlands	301049
China	101505603	Boron-containing small molecules

Supplementary Protection Certificates for KERYDIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2343304	757	Finland
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	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	PA2020524	Lithuania		PRODUCT NAME: KRISABOROLAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOJE; REGISTRATION NO/DATE: EU/1/19/1421 20200327
2343304	23/2020	Austria		PRODUCT NAME: CRISABOROL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES; REGISTRATION NO/DATE: EU/1/19/1421 (MITTEILUNG) 20200401

Market Dynamics and Financial Trajectory for KERYDIN (Tavaborole)

Last updated: December 28, 2025

Executive Summary

KERYDIN (tavaborole), a topical antifungal agent approved by the U.S. Food and Drug Administration (FDA) in 2016, targets onychomycosis—fungal infections of the nail plate predominantly caused by Trichophyton rubrum. Despite its unique mechanism of action, the drug faces competitive pressures from established oral and topical antifungals. The product's market performance hinges on evolving dermatological treatment paradigms, patient preferences, and regulatory developments. This analysis elucidates the key market drivers, competitive landscape, financial trajectory, and investment implications for KERYDIN over the next five years.

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1. Summary of KERYDIN (Tavaborole)

Attribute	Details
Therapeutic Class	Topical antifungal agent
Indication	Onychomycosis of the toenails and fingernails
Mechanism of Action	Inhibits fungal leucyl-tRNA synthetase, blocking fungal protein synthesis
Patent Status	Patent life expiring in 2030s; generic competition likely thereafter
Formulation	5% topical solution
FDA Approval	2016

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2. Market Landscape and Dynamics

2.1. Onychomycosis Market Size and Growth Projections

The global onychomycosis treatment market was valued at approximately USD 1.8 billion in 2022, with expectations of a compound annual growth rate (CAGR) of up to 5% through 2030 ([1]). The increasing prevalence of fungal infections driven by aging populations, comorbidities like diabetes, and expanding awareness fuels demand.

Market Segment	2022 Valuation	2030 Projection	CAGR (2022-2030)
Topical therapies	USD 600 million	USD 800 million	5%
Oral therapies	USD 1.2 billion	USD 1.6 billion	4.7%

Key drivers:

• Patient preference for non-invasive, topical treatments
• Rising incidence among diabetics and immunocompromised
• Increasing awareness and diagnosis rates

2.2. Competitive Landscape

Competitor	Product	Market Share (Est.)	Formulation	Price Point	Approval Year
Lamisil (terbinafine)	Oral	50%	Oral	Premium	1992
Ciclopirox (Penlac)	Topical solution	20%	Topical	Moderate	1993
Efinaconazole (Jublia)	Topical	15%	10%	Premium	2014
Tavaborole (KERYDIN)	Topical	10%	5%	Moderate	2016

KERYDIN is positioned as a fast-acting, convenient topical option with an 8-week treatment regimen, appealing to patients who seek alternatives to oral therapy's systemic risks.

2.3. Barriers to Market Penetration

• Limited awareness: Despite FDA approval, clinicians and patients may favor more familiar agents.
• Pricing and reimbursement: Moderate price point, but reimbursement hurdles exist.
• Efficacy perceptions: Slightly lower cure rates (~35%) compared to oral antifungals (~50%).

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3. Financial Trajectory and Forecasts

3.1. Revenue Projections (2023–2028)

Estimating KERYDIN's revenues hinges on prescription volumes, pricing strategies, and competitive positioning.

Year	Assumed Prescriptions (Thousands)	Price per Prescription (USD)	Estimated Revenue (USD Millions)	Growth Rate
2023	250	300	75	—
2024	350	310	108	44%
2025	450	320	144	33%
2026	550	330	182	26%
2027	650	340	221	21%
2028	750	350	263	19%

Assumptions: Growth driven primarily by increased awareness, expanded prescribing, and potential formulary inclusion; prices remain relatively stable with modest increases.

3.2. Cost Considerations

• Manufacturing costs: Estimated at 30% of revenue.
• Marketing and promotion: Approximately 20% of gross revenue.
• R&D investments: Minimal, given FDA approval; focus on line extensions or formulation improvements.

3.3. Profitability Outlook

Year	Gross Profit (USD Millions)	Operating Expenses	Operating Income	Margin
2023	52.5	15	37.5	50%
2024	81	22	59	55%
2025	115.2	30	85.2	59%
2026	136.2	42	94.2	69%
2027	161.2	52	109.2	68%
2028	184.9	62	122.9	66%

Note: Margins are optimistic given the premium nature of topical antifungals.

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4. Regulatory and Policy Environment

4.1. Patent and Exclusivity Landscape

• KERYDIN’s composition patent expires around 2030.
• Data exclusivity granted until at least 2022; likely extension or supplemental patents may offer further protection ([2]).

4.2. Reimbursement Policies

• Reimbursement depends on formulary placement; insurers favor drugs with proven efficacy and cost-effectiveness.
• As of 2023, coverage is improving but varies by insurer.

4.3. Patent Challenges and Generic Entry

• Anticipated generic competition post-2030 could commoditize KERYDIN, pressuring prices and margins.
• Companies may explore line extensions or combination therapies as differentiation strategies.

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5. Strategic Considerations for Stakeholders

Stakeholder	Strategic Implications
Pharmaceutical Company (Manufacturer)	Focus on expanding prescriber awareness, optimize pricing, and pursue line extensions or more potent formulations.
Investors	Evaluate growth prospects based on prescription trends, potential patent expiry effects, and competitive dynamics.
Regulators	Monitor for potential new indications, combination therapies, or biosimilar approvals that could influence the market.
Healthcare Providers	Consider efficacy, safety, and patient preferences when prescribing, favoring KERYDIN for rapid, topical treatment.

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6. Comparative Analysis with Competitors

Parameter	KERYDIN	Efinaconazole (Jublia)	Ciclopirox (Penlac)	Oral Terbinafine (Lamisil)
Approval Year	2016	2014	1993	1992
Formulation	Topical solution	Topical solution	Topical lacquer	Oral tablet
Treatment Duration	8 weeks	48 weeks	48 weeks	6-12 weeks
Cure Rates	approx. 35-40%	approx. 55-60%	approx. 35-40%	approx. 50-55%
Pricing (per course)	USD 2,400	USD 2,800	USD 1,500	USD 150 (oral)

KERYDIN offers a shorter, more patient-friendly regimen but faces efficacy challenges compared to newer topical formulations and systemic antifungals.

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7. Future Outlook and Innovation Potential

• Line extensions: Development of combination therapies (e.g., with corticosteroids or novel antifungals).
• Formulation improvements: Enhanced bioavailability or application ease.
• Digital health integration: Monitoring adherence via apps could bolster treatment success rates.
• Expanding indications: Beyond onychomycosis, potential in other superficial fungal infections.

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8. Key Takeaways

• Market Growth: The onychomycosis treatment market is expected to grow steadily (~5% CAGR), driven by demographic shifts and increased diagnosis.
• Competitive Position: KERYDIN maintains a niche as a short-duration topical therapy appealing to patients wary of systemic medications but faces competition from more efficacious or better-reimbursed options.
• Financial Outlook: Revenues are projected to grow modestly, reaching approximately USD 263 million by 2028, with margins remaining healthy amid competitive pressures.
• Challenges: Patent expiry near 2030 presents risks of generic erosion; efficacy perception remains a barrier.
• Opportunities: Focused innovation, strategic alliances, and patient-centric formulations could enhance market share.

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9. FAQs

Q1: What is the primary advantage of KERYDIN over other topical antifungals?
A1: Its rapid 8-week treatment course offers a shorter, more convenient regimen, potentially improving patient adherence compared to longer therapies like ciclopirox or efinaconazole.

Q2: How does KERYDIN compare in efficacy to oral antifungals?
A2: While oral agents like terbinafine have higher cure rates (up to 50-60%), KERYDIN offers a safer, topical alternative with cure rates around 35-40%, suitable for patients contraindicated for systemic therapy.

Q3: What is the outlook for generic competition post-2030?
A3: Patent expiration will likely lead to generic versions, exerting downward pressure on prices and market share, necessitating differentiation or line extension strategies.

Q4: Are there any regulatory or policy risks that could impact KERYDIN's market?
A4: Future policy shifts, reimbursement changes, or safety concerns could limit adoption; ongoing post-market surveillance and payer negotiations are critical.

Q5: What strategies could improve KERYDIN's market share?
A5: Enhancing formulary positioning, increasing prescriber awareness, improving efficacy perceptions, and exploring combination products or formulations.

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10. References

[1] MarketsandMarkets. "Fungal Infection Treatment Market," 2022.
[2] U.S. FDA. "KERYDIN (Tavaborole) Approval Letter," 2016.

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This comprehensive analysis equips pharmaceutical executives, investors, healthcare providers, and policymakers with actionable insights to navigate KERYDIN's market lifecycle and financial prospects.