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 ·  Patent Litigation & Settlement History ↓

IngredientACECLIDINE HYDROCHLORIDE
Application typeNDA
Application218585
Product001
Dosage formSOLUTION/DROPS
RouteOPHTHALMIC
StrengthEQ 1.44% BASE
Approval date2025-07-31
Marketing statusPrescription
Status event—
ApplicantLENZ THERAP
Product source

Current GenericRadar decision

Year2044
SelectionCANDIDATE
ReviewFINAL_CHECKING
Anchor typeDS_EQUIVALENT
Anchor date2044-03-15
Patent anchor2044-03-15
Exclusivity anchor2030-07-31
Protection date—
First Final ANDA—
Status event—

GNR judgment: CANDIDATE. Reference year: 2044. Anchor type: DS_EQUIVALENT. Patent anchor: 2044-03-15. Exclusivity anchor: 2030-07-31. Anchor date: 2044-03-15. Patent tail: no. Exclusivity tail: no. Review status: FINAL_CHECKING. Historical detailed rationale is retained in the evidence snapshot; this is a structured English summary, not a literal translation.

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
100523132034-03-24DP/U U-3741———
———
111793282034-03-24U U-3741———
———
98445372034-03-24DP/U U-3741———
———
126537792035-06-18U U-3741———
———
121280362039-10-08U U-3741———
———
125333472039-10-08U U-3741———
———
124149422044-03-15U U-3741———
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE—2030-07-31————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.
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.