GenericRadar
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Product profile · United States

KLISYRI

 ·  Patent Litigation & Settlement History ↓

IngredientTIRBANIBULIN
Application typeNDA
Application213189
Product001
Dosage formOINTMENT
RouteTOPICAL
Strength1%
Approval date2020-12-14
Marketing statusPrescription
Status event—
ApplicantALMIRALL
Product source

Current GenericRadar decision

Year2038
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeDS_EQUIVALENT_PATENT
Anchor date2038-03-12
Patent anchor2038-03-12
Exclusivity anchor2025-12-14
Protection date2038-09-07
First Final ANDA—
Status event—

POST_ANCHOR_RIGHTS_EXIST; US:NDA:213189:001; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
103230012027-12-28DP —NNDP
| B1C03P7 issued-claim review2026-10-15: DP
———
103230012027-12-28ORANGE_BOOK —NNDP
English description not available.
———
78514702029-02-02DS/DP/U U-3015NNDP
| B1C03P7 issued-claim review2026-10-15: DP
———
78514702029-02-02ORANGE_BOOK U-3015NNDP
English description not available.
———
73009312030-12-28DS/DP —YNTRUE_DS
| B1C03P7 issued-claim review2026-10-15: TRUE_DS
———
73009312030-12-28ORANGE_BOOK —YNTRUE_DS
English description not available.
———
106176932038-03-12U U-3015NNU
| B1C03P7 issued-claim review2026-10-15: U
———
106176932038-03-12ORANGE_BOOK U-3015NNU
English description not available.
———
114977502038-03-12U U-3015NYU
| B1C03P7 issued-claim review2026-10-15: U
———
114977502038-03-12ORANGE_BOOK U-3015NYU
English description not available.
———
126675762038-03-12U U-4577NNU
| B1C03P7 issued-claim review2026-10-15: U
———
126675762038-03-12ORANGE_BOOK U-4577NNU
English description not available.
———
106692362038-09-07DS/DP —NNDP
| B1C03P7 issued-claim review2026-10-15: DP
———
106692362038-09-07ORANGE_BOOK —NNDP
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2020-12-142025-12-14English description not available.YY2025-12-14
NCE
Full coverage date: 2025-12-14
Source
D-1922024-06-072027-06-07English description not available.NN——Source
D-1922024-06-072027-06-07English description not available.NN—
NCE
Full coverage date: —
Source

2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · Historical coverage: NOT_COMPLETE

Generic approval evidence

Application / productEventFinal dateTentative dateApplicantAuthorized genericExact mappingSource
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.

APIHolder / manufacturerHolder countryFiling typeNumberStatusFiled dateAvailable for referenceSourceLast 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 / productApplicantEvent / status First marketed Product mappingSourceLast 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 / productApplicantEvent / status Tentative date Follow-up final approvalProduct mappingSourceLast 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 / productApplicantEvent / status Certification event date Product mappingSourceLast 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 / productApplicantEvent / status Final approval date Product mappingSourceLast verified
No final-approval records are linked to this product.
Decision evidence (10)
TypeDateRoleBasisSource
PATENT2027-12-28HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2029-02-02HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2030-12-28HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2038-03-12HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2038-03-12CANONICAL_ANCHOREnglish description not available.Source
PATENT2038-03-12HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2038-09-07FTO_TAILEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2038-03-12CANONICAL_DECISIONPOST_ANCHOR_RIGHTS_EXIST; US:NDA:213189:001; exact Final ANDA not verified; not proof of generic absenceSource
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.