Product profile · United States

LIVMARLI

· Patent Litigation & Settlement History ↓

IngredientMARALIXIBAT CHLORIDE

Application typeNDA

Application214662

Product002

Dosage formSOLUTION

RouteORAL

StrengthEQ 19MG BASE/ML

Approval date2024-07-24

Marketing statusPrescription

Status event—

ApplicantMIRUM

Product source

Current GenericRadar decision

Year2031

SelectionDEEP_REVIEW

ReviewFINAL

Anchor typeEXCLUSIVITY

Anchor date2031-03-13

Patent anchor—

Exclusivity anchor2031-03-13

Protection date—

First Final ANDA—

Status event—

LIVMARLI NDA 214662/002: ODE-471 (PFIC age 5 years and older) and ODE-490 (PFIC age 12 months to under 5 years) jointly covered the whole approved age range only through 2031-03-13, the earlier expiry. ODE-490 continues as a partial-population exclusivity until 2031-07-24. Existing local ODE-471 linkage needs reconciliation; do not mistake absent local evidence for verified coverage. Later use patents remain separate FTO tails. Exact matching ODE rows in local database: 1 of 2.
Combined Exclusivity Coverage: ODE-471 (PFIC age 5 years and older, ends 2031-03-13) plus ODE-490 (PFIC age 12 months to under 5 years, ends 2031-07-24). These complementary age scopes jointly cover the approved PFIC population only through 2031-03-13, the earlier expiry. ODE-490 continues as a partial-population exclusivity tail through 2031-07-24. Exact local ODE-471 linkage for this product remains unreconciled; this coverage calculation is conditional.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
10512657	2032-10-26	U U-3973	—	—	—	—	—	—
11229661	2032-10-26	U U-3973	—	—	—	—	—	—
12350267	2032-10-26	U U-3973	—	—	—	—	—	—

Regulatory exclusivity

Code	Start date	End date	Entire product	All indications	Full coverage date	Combination	Source
NCE	—	2026-09-29	—	—	—	—	Source
ODE*	—	2028-09-29	—	—	—	—	Source
ODE*	—	2030-03-13	—	—	—	—	Source
ODE*	—	2031-03-13	—	—	—	—	Source
ODE-490	—	2031-07-24	—	—	2031-03-13	ODE-471 + ODE-490 Full coverage date: 2031-03-13 Status: PROVISIONAL_LOCAL_LINK_MISSING ODE-471 local exact-product record is missing. ODE-490 later protects only a younger PFIC subgroup until 2031-07-24.	Source

2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · Historical coverage: NOT_COMPLETE

Generic approval evidence

Application / product	Event	Final date	Tentative date	Applicant	Authorized generic	Exact mapping	Source
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.

API	Holder / manufacturer	Holder country	Filing type	Number	Status	Filed date	Available for reference	Source	Last 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 / product	Applicant	Event / status	First marketed	Product mapping	Source	Last 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 / product	Applicant	Event / status	Tentative date	Follow-up final approval	Product mapping	Source	Last 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 / product	Applicant	Event / status	Certification event date	Product mapping	Source	Last 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 / product	Applicant	Event / status	Final approval date	Product mapping	Source	Last 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.