Product profile · United States
KERYDIN
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
FDA_LEGAL_APPROVAL_WITHDRAWAL; canonical 2027 CANDIDATE; QUALIFYING_ANCHOR_WITH_NO_LATER_RIGHTS. FDA legal approval withdrawal effective date, not notice publication.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US9549938 | 2026-08-16 | U/PED U-1951 | N | Y | DS_EQUIVALENT Independent method treats human toenail tinea unguium by topical tavaborole; dependent claims specify both labeled Trichophyton organisms and5% solution. Entire KERYDIN indication corresponds. | — | 2026-08-16 | — |
| US9566289 | 2026-08-16 | DP/PED — | N | N | DP Tavaborole with a topical carrier or solvent/chelating-agent system. These are formulation claims, not standalone compound or unrestricted clinical-use claims. | — | 2026-08-16 | — |
| US9566290 | 2026-08-16 | U/PED U-1970 | N | Y | DS_EQUIVALENT Independent method treats toenail onychomycosis from either labeled Trichophyton organism by topical tavaborole inhibiting aminoacyl-tRNA synthetase. KERYDIN label confirms the leucyl-tRNA-synthetase mechanism, not an unrelated assay-only effect. | — | 2026-08-16 | — |
| US9572823 | 2026-08-16 | U/PED U-1970 | N | Y | DS_EQUIVALENT Independent method delivers tavaborole through the dorsal nail plate to treat toenail onychomycosis from either labeled Trichophyton organism. KERYDIN labeled topical nail administration and nail-penetration treatment correspond. | — | 2026-08-16 | — |
| US7767657 | 2027-05-22 | DP — | N | N | DP Topical tavaborole pharmaceutical formulation plus excipient; independent claims are formulation and carrier compositions, not standalone tavaborole compound protection. Formulation title/official DS flags do not establish TRUE_DS. | — | — | — |
| US7582621 | 2027-11-26 | U/PED U-2016,U-718 | N | Y | DS_EQUIVALENT Issued independent claims1/11/12 are tavaborole infection/onychomycosis/fungal-growth treatment methods, not standalone compound claims. KERYDIN sole toenail onychomycosis indication due to T.rubrum/T.mentagrophytes is entirely within the broad methods. | — | 2027-11-26 | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2014-07-07 | 2019-07-07 | FULL_EXACT_PRODUCT_APPROVED_SCOPE; NCE covers the exact 5% topical tavaborole product and all approved toenail onychomycosis use caused by T. rubrum or T. mentagrophytes. The 2018 label includes age 6 and older; active-moiety NCE applies across uses during its term. | Y | Y | 2019-07-07 | Source |
2026-10-12 · HISTORICAL_RECORDS_RECOVERED · Historical coverage: ANNUALS_2011_2026_REVIEWED
2026-10-10 · NO_RECORD_IN_CURRENT_SNAPSHOT · Historical coverage: NOT_COMPLETE
Generic approval evidence
| Application / product | Event | Final date | Tentative date | Applicant | Authorized generic | Exact mapping | Source |
|---|---|---|---|---|---|---|---|
| No generic approval facts are linked to this product. | |||||||
Market Entry Information
API filings, authorized generics and linked regulatory milestones.
API Master Files & Certifications 0 records
Ingredient-level registrations from linked public manufacturer portfolios. A filing does not establish supply to this finished product. DMFs are not FDA approvals.
| API | Holder / manufacturer | Holder country | Filing type | Number | Status | Filed date | Available for reference | Source | Last verified |
|---|---|---|---|---|---|---|---|---|---|
| No master-file or certification records are linked through public manufacturer portfolios. | |||||||||
Authorized Generics 0 records
Authorized generics are shown separately from independent ANDA approvals.
| Application / product | Applicant | Event / status | First marketed | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No authorized-generic records are linked to this product. | ||||||
Tentative ANDA Approvals 0 records
Tentative approval is not final approval. Historical tentative approvals remain visible after a linked final approval.
| Application / product | Applicant | Event / status | Tentative date | Follow-up final approval | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|---|
| No tentative-approval records are linked to this product. | |||||||
Paragraph IV Challenges 0 records
Paragraph IV challenges below are sourced from legal records separately from FDA approvals. An ANDA filing, lawsuit or settlement does not establish final approval or commercial launch.
| Application / product | Applicant | Event / status | Certification event date | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No structured Paragraph IV certification events are linked in the available approval evidence. | ||||||
Final ANDA Approvals 0 records
Approval dates do not establish commercial launch. Product mapping is shown for each linked record.
| Application / product | Applicant | Event / status | Final approval date | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No final-approval records are linked to this product. | ||||||
Decision evidence (8)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2026-08-16 | LISTING_CONTEXT | Tavaborole with a topical carrier or solvent/chelating-agent system. These are formulation claims, not standalone compound or unrestricted clinical-use claims. | Source |
| PATENT | 2026-08-16 | LISTING_CONTEXT | Independent method delivers tavaborole through the dorsal nail plate to treat toenail onychomycosis from either labeled Trichophyton organism. KERYDIN labeled topical nail administration and nail-penetration treatment correspond. | Source |
| PATENT | 2026-08-16 | LISTING_CONTEXT | Independent method treats toenail onychomycosis from either labeled Trichophyton organism by topical tavaborole inhibiting aminoacyl-tRNA synthetase. KERYDIN label confirms the leucyl-tRNA-synthetase mechanism, not an unrelated assay-only effect. | Source |
| PATENT | 2026-08-16 | LISTING_CONTEXT | Independent method treats human toenail tinea unguium by topical tavaborole; dependent claims specify both labeled Trichophyton organisms and5% solution. Entire KERYDIN indication corresponds. | Source |
| PATENT | 2027-05-22 | LISTING_CONTEXT | Topical tavaborole pharmaceutical formulation plus excipient; independent claims are formulation and carrier compositions, not standalone tavaborole compound protection. Formulation title/official DS flags do not establish TRUE_DS. | Source |
| PATENT | 2027-11-26 | CANONICAL_ANCHOR | Issued independent claims1/11/12 are tavaborole infection/onychomycosis/fungal-growth treatment methods, not standalone compound claims. KERYDIN sole toenail onychomycosis indication due to T.rubrum/T.mentagrophytes is entirely within the broad methods. | Source |
| REGULATORY_EXCLUSIVITY | 2019-07-07 | SCOPE_CONTEXT | FULL_EXACT_PRODUCT_APPROVED_SCOPE; NCE covers the exact 5% topical tavaborole product and all approved toenail onychomycosis use caused by T. rubrum or T. mentagrophytes. The 2018 label includes age 6 and older; active-moiety NCE applies across uses during its term. | Source |
| REGULATORY_STATUS | 2024-12-19 | TERMINAL_STATUS | FDA_LEGAL_APPROVAL_WITHDRAWAL; canonical 2027 CANDIDATE; QUALIFYING_ANCHOR_WITH_NO_LATER_RIGHTS. FDA legal approval withdrawal effective date, not notice publication. | Source |
Independent legal-event information
Litigation & Settlement History
Settlement launch rights generally apply only to the named parties and product scope. These records do not change GenericRadar patent/exclusivity anchors or current decisions.
No litigation or settlement record currently linked to this product.