LIVMARLI
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
LIVMARLI NDA 214662/001: ODE-379 (ALGS age 1 year and older) and ODE-429 (ALGS age 3 months to under 1 year) jointly covered the whole approved age range only through 2028-09-29, the earlier expiry. ODE-429 continues as a partial-population exclusivity until 2030-03-13. Later use patents remain separate FTO tails. Exact matching ODE rows in local database: 2 of 2.
Combined Exclusivity Coverage: ODE-379 (ALGS age 1 year and older, ends 2028-09-29) plus ODE-429 (ALGS age 3 months to under 1 year, ends 2030-03-13). These complementary age scopes jointly cover the approved ALGS population only through 2028-09-29, the earlier expiry. ODE-429 continues as a partial-population exclusivity tail through 2030-03-13. Later use-patent tails are separate.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 11260053 | 2031-05-26 | U U-3974 | — | — | — | — | — | — |
| 11260053 | 2031-05-26 | U U-3290 | — | — | — | — | — | — |
| 10512657 | 2032-10-26 | U U-3850 | — | — | — | — | — | — |
| 11229661 | 2032-10-26 | U U-3850 | — | — | — | — | — | — |
| 11376251 | 2032-10-26 | U U-3290 | — | — | — | — | — | — |
| 11376251 | 2032-10-26 | U U-3974 | — | — | — | — | — | — |
| 11229647 | 2040-02-12 | U U-3290 | — | — | — | — | — | — |
| 11229647 | 2040-02-12 | U U-3974 | — | — | — | — | — | — |
| 11497745 | 2040-02-12 | U U-3974 | — | — | — | — | — | — |
| 11497745 | 2040-02-12 | U U-3290 | — | — | — | — | — | — |
| 11918578 | 2040-02-12 | U U-3290 | — | — | — | — | — | — |
| 11918578 | 2040-02-12 | U U-3974 | — | — | — | — | — | — |
| 12599602 | 2040-02-12 | U U-3290 | — | — | — | — | — | — |
| 12599602 | 2040-02-12 | U U-3974 | — | — | — | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NPP | — | 2026-03-13 | — | — | — | — | Source | |
| NCE | — | 2026-09-29 | — | — | — | — | Source | |
| I-938 | — | 2027-03-13 | — | — | — | — | Source | |
| ODE-379 | — | 2028-09-29 | — | — | 2028-09-29 | ODE-379 + ODE-429
Full coverage date: 2028-09-29
Status: CONFIRMED_LOCAL_CODES After 2028-09-29, ODE-429 protects only the younger ALGS group until 2030-03-13. | Source | |
| ODE-429 | — | 2030-03-13 | — | — | 2028-09-29 | ODE-379 + ODE-429
Full coverage date: 2028-09-29
Status: CONFIRMED_LOCAL_CODES After 2028-09-29, ODE-429 protects only the younger ALGS group until 2030-03-13. | Source | |
| ODE-471 | — | 2031-03-13 | — | — | — | — | 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. | ||||||
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.