GenericRadar
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Product profile · United States

EKTERLY

 ·  Patent Litigation & Settlement History ↓

IngredientSEBETRALSTAT
Application typeNDA
Application219301
Product001
Dosage formTABLET
RouteORAL
Strength300MG
Approval date2025-07-03
Marketing statusPrescription
Status event—
ApplicantKALVISTA
Product source

Current GenericRadar decision

Year2035
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeTRUE_DS_PATENT
Anchor date2035-11-26
Patent anchor2035-11-26
Exclusivity anchor2032-07-03
Protection date2039-01-26
First Final ANDA—
Status event—

POST_ANCHOR_RIGHTS_EXIST; US:NDA:219301:001; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
103642382035-11-26DS/DP —YNTRUE_DS
| B1C03P8 issued-claim review2026-10-15: TRUE_DS
———
103642382035-11-26ORANGE_BOOK —YNTRUE_DS
English description not available.
———
106117582035-11-26U U-4223NYU
| B1C03P8 issued-claim review2026-10-15: U
———
106117582035-11-26ORANGE_BOOK U-4223NYU
English description not available.
———
110015782035-11-26DS/DP —YNTRUE_DS
| B1C03P8 issued-claim review2026-10-15: TRUE_DS
———
110015782035-11-26ORANGE_BOOK —YNTRUE_DS
English description not available.
———
110848092035-11-26DS/DP/U U-4223YNTRUE_DS
| B1C03P8 issued-claim review2026-10-15: TRUE_DS
———
110848092035-11-26ORANGE_BOOK U-4223YNTRUE_DS
English description not available.
———
111986912035-11-26U U-4223NYU
| B1C03P8 issued-claim review2026-10-15: U
———
111986912035-11-26ORANGE_BOOK U-4223NYU
English description not available.
———
117390682037-06-23U U-4223NNU
| B1C03P8 issued-claim review2026-10-15: U
———
117390682037-06-23ORANGE_BOOK U-4223NNU
English description not available.
———
112305372037-12-25DS/DP —NNDP
| B1C03P8 issued-claim review2026-10-15: DP
———
112305372037-12-25ORANGE_BOOK —NNDP
English description not available.
———
112349392039-01-26DP/U U-4223NNDP
| B1C03P8 issued-claim review2026-10-15: DP
———
112349392039-01-26ORANGE_BOOK U-4223NNDP
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2025-07-032030-07-03English description not available.YY2030-07-03—Source
NCE2025-07-032030-07-03English description not available.YY2030-07-03
ODE-534
Full coverage date: 2030-07-03
Source
ODE-5342025-07-032032-07-03English description not available.YY2032-07-03—Source
ODE-5342025-07-032032-07-03English description not available.YY2032-07-03
ODE-534
Full coverage date: 2032-07-03
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 (11)
TypeDateRoleBasisSource
PATENT2035-11-26CANONICAL_ANCHOREnglish description not available.Source
PATENT2035-11-26CANONICAL_ANCHOREnglish description not available.Source
PATENT2035-11-26CANONICAL_ANCHOREnglish description not available.Source
PATENT2035-11-26CANONICAL_ANCHOREnglish description not available.Source
PATENT2035-11-26CANONICAL_ANCHOREnglish description not available.Source
PATENT2037-06-23FTO_TAILEnglish description not available.Source
PATENT2037-12-25FTO_TAILEnglish description not available.Source
PATENT2039-01-26FTO_TAILEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2035-11-26CANONICAL_DECISIONPOST_ANCHOR_RIGHTS_EXIST; US:NDA:219301:001; 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.