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Product profile · United States

LODOCO

 ·  Patent Litigation & Settlement History ↓

IngredientCOLCHICINE
Application typeNDA
Application215727
Product001
Dosage formTABLET
RouteORAL
Strength0.5MG
Approval date2023-06-16
Marketing statusPrescription
Status event—
ApplicantAGEPHA PHARMA FZ
Product source

Current GenericRadar decision

Year2033
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeDRUG_SUBSTANCE
Anchor date2033-11-01
Patent anchor2033-11-01
Exclusivity anchor—
Protection date—
First Final ANDA—
Status event—

GNR judgment: DEEP_REVIEW. Reference year: 2033. Anchor type: DRUG_SUBSTANCE. Patent anchor: 2033-11-01. Exclusivity anchor: not recorded. Anchor date: 2033-11-01. Patent tail: yes. Exclusivity tail: no. Review status: FINAL. 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
102068912033-11-01U U-3641———
———
102652812033-11-01U U-3639———
———
108427622033-11-01U U-3640———
———
110268992033-11-01U U-3639———
———
110269002033-11-01U U-3639———
———
110269012033-11-01U U-3638———
———
119445942033-11-01U U-3864———
———
119445952033-11-01U U-3868———
———
119445952033-11-01U U-3867———
———
122330352033-11-01U U-4132———
———
122800252033-11-01U U-4168———
———
123646752033-11-01U U-3639———
———
97441442033-11-01U U-3643———
———
101305852034-05-09U U-3642———
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
No exclusivity facts are recorded in this product snapshot.

2026-10-10 · NO_RECORD_IN_CURRENT_SNAPSHOT · 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.