GenericRadar
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Product profile · United States

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 ·  Patent Litigation & Settlement History ↓

IngredientPALTUSOTINE HYDROCHLORIDE
Application typeNDA
Application219070
Product002
Dosage formTABLET
RouteORAL
StrengthEQ 30MG BASE
Approval date2025-09-25
Marketing statusPrescription
Status event—
ApplicantCRINETICS
Product source

Current GenericRadar decision

Year2041
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typePATENT
Anchor date2041-09-07
Patent anchor2041-09-07
Exclusivity anchor2032-09-25
Protection date2044-03-25
First Final ANDA—
Status event—

POST_ANCHOR_RIGHTS_EXIST; US:NDA:219070:002; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
103515472037-07-12DS/DP/U U-4283YNTRUE_DS
English description not available.
———
103515472037-07-12ORANGE_BOOK U-4283YNTRUE_DS
English description not available.
———
105973772037-07-12DS/DP/U U-4283YNTRUE_DS
English description not available.
———
105973772037-07-12ORANGE_BOOK U-4283YNTRUE_DS
English description not available.
———
108758392037-07-12U U-4283NYU
English description not available.
———
108758392037-07-12ORANGE_BOOK U-4283NYU
English description not available.
———
114143972037-07-12DS/DP/U U-4283YNTRUE_DS
English description not available.
———
114143972037-07-12ORANGE_BOOK U-4283YNTRUE_DS
English description not available.
———
98964322037-07-12DS/DP/U U-4283YNTRUE_DS
English description not available.
———
98964322037-07-12ORANGE_BOOK U-4283YNTRUE_DS
English description not available.
———
104649182039-01-16DS —NYU
English description not available.
———
104649182039-01-16ORANGE_BOOK —NYU
English description not available.
———
112666412041-09-07DP/U U-4283NNDP
English description not available.
———
112666412041-09-07ORANGE_BOOK U-4283NNDP
English description not available.
———
119576742041-09-07U U-4283NYU
English description not available.
———
119576742041-09-07ORANGE_BOOK U-4283NYU
English description not available.
———
122080922044-03-25U U-4282NNU
English description not available.
———
122080922044-03-25ORANGE_BOOK U-4282NNU
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2025-09-252030-09-25English description not available.YY2030-09-25—Source
NCE2025-09-252030-09-25English description not available.YY2030-09-25
ODE-537
Full coverage date: 2030-09-25
Source
ODE-5372025-09-252032-09-25English description not available.YY2032-09-25—Source
ODE-5372025-09-252032-09-25English description not available.YY2032-09-25
ODE-537
Full coverage date: 2032-09-25
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 (12)
TypeDateRoleBasisSource
PATENT2037-07-12HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2037-07-12HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2037-07-12HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2037-07-12HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2037-07-12HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2039-01-16HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2041-09-07HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2041-09-07CANONICAL_ANCHOREnglish description not available.Source
PATENT2044-03-25FTO_TAILEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2041-09-07CANONICAL_DECISIONPOST_ANCHOR_RIGHTS_EXIST; US:NDA:219070:002; 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.