GenericRadar
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Product profile · United States

XDEMVY

 ·  Patent Litigation & Settlement History ↓

IngredientLOTILANER
Application typeNDA
Application217603
Product001
Dosage formSOLUTION/DROPS
RouteOPHTHALMIC
Strength0.25%
Approval date2023-07-24
Marketing statusPrescription
Status event—
ApplicantTARSUS
Product source

Current GenericRadar decision

Year2038
SelectionCANDIDATE
ReviewFINAL
Anchor typePATENT
Anchor date2038-12-14
Patent anchor2038-12-14
Exclusivity anchor2028-07-24
Protection date2038-12-14
First Final ANDA—
Status event—

NO_POST_ANCHOR_RIGHTS; US:NDA:217603:001; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
83836592030-01-17DS/DP —YNTRUE_DS
English description not available.
———
83836592030-01-17ORANGE_BOOK —YNTRUE_DS
English description not available.
———
108355172038-12-14U U-3674NYU
English description not available.
———
108355172038-12-14ORANGE_BOOK U-3674NYU
English description not available.
———
111978472038-12-14U U-3674NYU
English description not available.
———
111978472038-12-14ORANGE_BOOK U-3674NYU
English description not available.
———
116908262038-12-14U U-3674NYU
English description not available.
———
116908262038-12-14ORANGE_BOOK U-3674NYU
English description not available.
———
116908272038-12-14U U-3674NYU
English description not available.
———
116908272038-12-14ORANGE_BOOK U-3674NYU
English description not available.
———
117521372038-12-14DP —NNDP
English description not available.
———
117521372038-12-14ORANGE_BOOK —NNDP
English description not available.
———
121717502038-12-14U U-3674NNU
English description not available.
———
121717502038-12-14ORANGE_BOOK U-3674NNU
English description not available.
———
122139642038-12-14DP —NNDP
English description not available.
———
122139642038-12-14ORANGE_BOOK —NNDP
English description not available.
———
123646852038-12-14DP —NNDP
English description not available.
———
123646852038-12-14ORANGE_BOOK —NNDP
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2023-07-242028-07-24English description not available.YY2028-07-24—Source
NCE2023-07-242028-07-24English description not available.YY2028-07-24
NCE
Full coverage date: 2028-07-24
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
PATENT2030-01-17HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2038-12-14CANONICAL_ANCHOREnglish description not available.Source
PATENT2038-12-14CANONICAL_ANCHOREnglish description not available.Source
PATENT2038-12-14CANONICAL_ANCHOREnglish description not available.Source
PATENT2038-12-14CANONICAL_ANCHOREnglish description not available.Source
PATENT2038-12-14HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2038-12-14HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2038-12-14HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2038-12-14HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2038-12-14CANONICAL_DECISIONNO_POST_ANCHOR_RIGHTS; US:NDA:217603:001; 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.