Product profile · United States
MARQIBO KIT
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
FDA_APPROVAL_WITHDRAWAL; canonical rights assessment 2019 DEEP_REVIEW; POST_ANCHOR_TAIL.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US5543152 | 2014-06-20 | DP — | N | N | DP Sphingomyelin/cholesterol liposome with acidic interior and drug-loading/pH requirements. | — | — | — |
| US5741516 | 2014-06-20 | DP — | N | Y | DS_EQUIVALENT Method claim 16 administers the claimed liposomal alkaloid composition to a susceptible tumor without a relapse or fixed-dose limitation. MARQIBO is liposomal vincristine for ALL; this method encompasses both relapsed and progressed disease in its historical approved indication. The product remains FDA-withdrawn. | — | — | — |
| US5814335 | 2014-06-20 | DP — | N | N | DP_PROCESS Liposomal alkaloid delivery product made by formation in acidic buffer and suspension in a higher-pH buffer; product-by-process claim, confirmed in issued USPTO PDF. | — | — | — |
| US6723338 | 2020-03-31 | U U-1271 | N | N | U Relapsed lymphoma/leukemia after at least one prior multi-agent regimen. MARQIBO also covered progressed disease after two or more lines; a relapse-only condition does not establish the whole approved refractory/progression population. | — | — | — |
| US7887836 | 2020-03-31 | U U-1271 | N | N | U Liposomal vincristine cancer treatment with 1.5–2.4 mg/m2 dosing and lipid/drug-concentration restrictions. Label dose modifications may fall below this range; retain the conditional method, not full-product scope. | — | — | — |
| US7247316 | 2020-09-25 | DP — | N | N | DP Three-vial vincristine/liposome/phosphate-buffer kit with concentrations, pH and lipid ratios; not a broad vincristine substance claim. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NP | 2012-08-09 | 2015-08-09 | ODE-28 covers the sole historical adult Ph-negative ALL indication, second/later relapse or progression after at least two therapies. Historical expiry remains separate from withdrawal on 2022-05-02. | Y | Y | 2015-08-09 | Source | |
| ODE | 2012-08-09 | 2019-08-09 | ODE-28 covers the sole historical adult Ph-negative ALL indication, second/later relapse or progression after at least two therapies. Historical expiry remains separate from withdrawal on 2022-05-02. | Y | Y | 2019-08-09 | Source |
2026-10-12 · HISTORICAL_RECORDS_RECOVERED · Historical coverage: ANNUALS_2011_2026_REVIEWED
2026-10-10 · NO_RECORD_IN_CURRENT_SNAPSHOT · 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. | ||||||
Decision evidence (9)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2014-06-20 | LISTING_CONTEXT | Sphingomyelin/cholesterol liposome with acidic interior and drug-loading/pH requirements. | Source |
| PATENT | 2014-06-20 | LISTING_CONTEXT | Liposomal alkaloid delivery product made by formation in acidic buffer and suspension in a higher-pH buffer; product-by-process claim, confirmed in issued USPTO PDF. | Source |
| PATENT | 2014-06-20 | CANONICAL_ANCHOR | Method claim 16 administers the claimed liposomal alkaloid composition to a susceptible tumor without a relapse or fixed-dose limitation. MARQIBO is liposomal vincristine for ALL; this method encompasses both relapsed and progressed disease in its historical approved indication. The product remains FDA-withdrawn. | Source |
| PATENT | 2020-03-31 | FTO_TAIL | Relapsed lymphoma/leukemia after at least one prior multi-agent regimen. MARQIBO also covered progressed disease after two or more lines; a relapse-only condition does not establish the whole approved refractory/progression population. | Source |
| PATENT | 2020-03-31 | FTO_TAIL | Liposomal vincristine cancer treatment with 1.5–2.4 mg/m2 dosing and lipid/drug-concentration restrictions. Label dose modifications may fall below this range; retain the conditional method, not full-product scope. | Source |
| PATENT | 2020-09-25 | FTO_TAIL | Three-vial vincristine/liposome/phosphate-buffer kit with concentrations, pH and lipid ratios; not a broad vincristine substance claim. | Source |
| REGULATORY_EXCLUSIVITY | 2015-08-09 | SCOPE_CONTEXT | ODE-28 covers the sole historical adult Ph-negative ALL indication, second/later relapse or progression after at least two therapies. Historical expiry remains separate from withdrawal on 2022-05-02. | Source |
| REGULATORY_EXCLUSIVITY | 2019-08-09 | SCOPE_CONTEXT | ODE-28 covers the sole historical adult Ph-negative ALL indication, second/later relapse or progression after at least two therapies. Historical expiry remains separate from withdrawal on 2022-05-02. | Source |
| REGULATORY_STATUS | 2022-05-02 | TERMINAL_STATUS | FDA_APPROVAL_WITHDRAWAL; canonical rights assessment 2019 DEEP_REVIEW; POST_ANCHOR_TAIL. | Source |
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.