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Product profile · United States

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 ·  Patent Litigation & Settlement History ↓

IngredientBELUMOSUDIL MESYLATE
Application typeNDA
Application214783
Product001
Dosage formTABLET
RouteORAL
StrengthEQ 200MG BASE
Approval date2021-07-16
Marketing statusPrescription
Status event—
ApplicantKADMON PHARMS LLC
Product source

Current GenericRadar decision

Year2034
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeTRUE_DS_PATENT
Anchor date2034-06-20
Patent anchor2034-06-20
Exclusivity anchor2026-07-16
Protection date2042-07-14
First Final ANDA—
Status event—

US8357693 c24 belumosudil;PTE1694days from2029-10-30. Infection/subtype uses remain tails.

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
101839312033-10-07U U-4260———
———
101839312033-10-07U U-3246———
———
106966602033-10-07U U-3246———
———
106966602033-10-07U U-4260———
———
83576932034-06-20DS/DP/U U-4259———
———
113115412035-04-09U U-3369———
———
120972022042-07-14U U-4014———
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE—2026-07-16YY——Source
ODE-362—2028-07-16————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 (1)
TypeDateRoleBasisSource
ANNUAL_DECISION_RECHECK—ANCHOR_AND_TAILUS8357693 c24 belumosudil;PTE1694days from2029-10-30. Infection/subtype uses remain tails.Source
Decision history
CurrentYearStatusReviewAnchorJudged
Y2034DEEP_REVIEWFINAL2034-06-202026-10-17 20:32:21
N2034DEEP_REVIEWFINAL2034-06-202026-10-14 18:32:45
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.