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:	387
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
Australia	2006214247	Boron-containing small molecules
Australia	2006333527	Boron-containing small molecules
Australia	2010203096	Boron-containing small molecules
Australia	2011200994	Boron-containing small molecules

Supplementary Protection Certificates for KERYDIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	301049	Netherlands		PRODUCT NAME: CRISABOROLE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; 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

Last updated: July 25, 2026

Kerydin (tavaborole): market dynamics and financial trajectory

Kerydin (tavaborole 5% solution) is a dermatology branded product with exposure concentrated in the United States. Financial trajectory is driven by (1) limited addressable indication depth (onychomycosis), (2) intensity of generic and competitive erosion in topical dermatology, and (3) payer, formulary, and hub/coverage dynamics typical for niche dermatology launches. The product’s near- and medium-term outlook is shaped by patent and exclusivity timing in the onychomycosis space and the ability of competitors to price aggressively once eligibility barriers clear.

What is Kerydin’s commercial market and demand base in onychomycosis

Kerydin (tavaborole) targets onychomycosis, a chronic fungal nail infection. Commercial demand is affected by:

• Patient path to diagnosis: a meaningful share of patients are first treated in primary care or dermatology rather than directly in podiatry, which affects conversion to prescription therapy.
• Clinical substitution behavior: clinicians and patients commonly compare topical nail antifungals to oral antifungals (terbinafine/itraconazole) on efficacy and treatment time.
• Chronicity: recurrence requires repeat treatment, supporting repeat prescriptions, but also increases sensitivity to price at renewal points.

Where Kerydin competes: topical antifungal and nail-specific portfolios

Kerydin competes against topical nail antifungals and competing standards of care. Key commercial determinants for each are:

• Formulary tiering: formulary placement is the single largest driver of net pricing.
• Copay and access programs: access programs can materially influence market penetration early, but often become less impactful once generic or lower-priced alternatives appear.
• Health plan management: step edits and prior authorization are used for high-cost branded products in dermatology.

How is Kerydin priced and how do net price dynamics typically move

Kerydin’s market economics follow a pattern common to branded topical dermatology:

• Launch and early expansion: higher gross-to-net spread initially as the brand buys access through copays and distribution incentives.
• Mid-cycle normalization: as clinician familiarity grows, net-to-gross improves if coverage is stable.
• Erosion phase: when generic or therapeutically substitutable products gain share, the net price compresses through rebates, contract repricing, and payer steer.

What drives gross-to-net changes for niche brands

For Kerydin specifically, gross-to-net typically shifts with:

• Formulary re-formats by PBMs
• Utilization management (prior authorization tightening or loosening)
• Channel shifts (retail vs specialty pharmacy distribution norms for dermatology products)

What is Kerydin’s revenue trajectory: how market forces usually translate into financial performance

A realistic financial trajectory for Kerydin is segmented into three phases:

1. Pre-erosion growth
   • Revenue growth relies on formulary access, prescriber uptake, and sustained patient adherence to long-duration topical regimens.
2. Plateau to modest decline
   • Growth slows as market penetration saturates higher-probability prescribers and as alternatives improve efficacy data or access.
3. Erosion and re-baselining
   • Once competitive pricing pressure intensifies, revenue stabilizes only if the brand retains differentiation on ease of use, patient outcomes, and payer coverage.

Because Kerydin is a dermatology niche rather than mass-market therapy, financial performance typically shows:

• smaller absolute revenue base than systemic dermatology brands
• higher sensitivity to formulary disruptions
• faster net revenue volatility from access changes

What patents protect Kerydin (tavaborole) and how does the estate affect pricing power

Kerydin’s commercial life depends on protecting:

• the active compound and its therapeutic use for onychomycosis
• the topical formulation and concentration
• method-of-use claims for specific treatment regimens
• manufacturing and process claims that can block early generic readiness

How patent life links to competitive entry risk

Patent and exclusivity strength directly affects:

• the timing of ANDA or 505(b)(2) entry for small-molecule generics
• the speed of shelf replacement (immediate switching vs delayed adoption)
• the degree of price discount required to win share after launch

When does Kerydin lose exclusivity and what generic entry risks exist

Generic entry risk rises as patent and regulatory exclusivity approach expiration for:

• composition-of-matter claims
• formulation and method-of-use claims
• any Orange Book-listed patents tied to NDA coverage

What to watch for in the run-up to entry

In onychomycosis topical markets, generic adoption is often accelerated by:

• PBM benefit design that labels the brand as non-preferred once a lower-priced alternative is available
• pharmacy benefit contract changes that alter dispensing economics
• competitive promotion through payer rebates rather than physician education

What is the Orange Book status of Kerydin and how does it map to litigation exposure

Orange Book status is the operational layer that connects patent listings to:

• which generic applicants can attempt Paragraph IV challenges
• which patents are the most litigated or most likely to be waived
• whether settlement agreements constrain entry timing

Paragraph IV challenges and settlement dynamics that affect revenue

Revenue impact tends to be largest when:

• a Paragraph IV filer wins early by invalidation or non-infringement
• settlements push entry dates while simultaneously shifting market contracts away from the brand

What patent litigation affects Kerydin and what it implies for future competition

Patent litigation affects not only entry timing but also the brand’s ability to defend pricing and formulary status. The strongest commercial impacts come from:

• Named patent scope: if litigation targets broad claims that block all generics, delay is longer.
• Settlement terms: pay-for-delay structures or covenant-not-to-sue provisions can freeze competition.
• Trial outcomes and appeal status: even partial wins can narrow the effective protection.

How does Kerydin compare with competing onychomycosis products on market resilience

Kerydin’s resilience versus alternatives is typically shaped by:

• Differentiation: ease-of-use, patient adherence, tolerability, and duration
• Access: whether PBMs maintain preferred tier placement
• Switchability: how quickly patients and clinicians switch once a cheaper option is covered

Segmented commercial comparators that matter

• topical nail solutions vs other topical delivery systems
• topical antifungals vs oral antifungals (adherence vs efficacy tradeoffs)
• branded vs generic topical offerings after exclusivity loss

Which companies are challenging Kerydin and what their entry strategy signals

Competitor entry strategy in topical antifungals typically follows:

• targeting immediate substitution at formulary preferred status
• leveraging distribution agreements with pharmacy chains
• accelerating launch if litigation settlement windows expire

In onychomycosis, competitor positioning is often less about clinical innovation and more about access-driven volume capture.

How do payer dynamics and prior authorization affect Kerydin’s financial performance

Payer management drives both volume and net revenue:

• Prior authorization can reduce scripts early in a product life cycle if criteria are strict.
• Step therapy can shift prescribers toward oral antifungals or cheaper alternatives.
• Formulary moves can cause step-function declines in net revenue rather than smooth erosion.

Key formularies and managed care levers

Commercial impact usually comes from:

• PBM contract renewals
• national account changes in retail chains
• specialty pharmacy steering for certain dermatology pathways

What is the manufacturing and supply chain/IP barrier for Kerydin

Supply chain barriers tend to be moderate for topical dermatology unless formulation or process patents remain enforceable. Competitive entry can be slowed by:

• formulation complexity and stability requirements
• manufacturing process claims and validated controls
• packaging and labeling requirements tied to NDA-specific information

Revenue exposure outlook: what drives upside or downside for Kerydin

Upside drivers typically include:

• stable preferred coverage and reduced utilization management
• improved adherence and outcomes that encourage re-prescription
• contract normalization after launch volatility

Downside drivers typically include:

• accelerated competitive switching after generic entry eligibility clears
• formulary downgrade to non-preferred tiers
• higher rebates required to defend share

Key Takeaways

• Kerydin’s financial trajectory is dominated by access and pricing erosion risk common to niche topical dermatology.
• Market dynamics are driven by onychomycosis patient conversion, adherence to long topical treatment, and payer formulary positioning.
• Patent and Orange Book-linked exclusivity timing governs the pace of generic entry and the magnitude of revenue compression.
• The strongest revenue inflection points typically occur at PBM contract resets and after any successful Paragraph IV or settlement-driven entry.

FAQs

1. How fast do patients switch from Kerydin to a generic topical nail antifungal after entry?
2. What formulary tier placement changes usually trigger the largest net revenue decline for Kerydin?
3. How do prior authorization criteria for onychomycosis topical drugs affect brand volume?
4. Do settlements in onychomycosis topical patent cases typically include delayed entry or design-around pathways?
5. What manufacturing or formulation constraints most often slow generic competitors in topical dermatology?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drug Approval Packages: Kerydin (tavaborole) NDA information. U.S. Food and Drug Administration.

DrugChatter Q&A for KERYDIN

Kerydin 5 topical solution price?
Is Kerydin effective for onychomycosis?