Product profile · United States
FUSILEV
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
FDA_APPROVAL_WITHDRAWAL; canonical rights assessment 2011 DEEP_REVIEW; APPROVAL_YEAR_FALLBACK.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US6500829 | 2022-03-07 | DS/DP — | N | N | DP_U Pharmaceutical compositions with at least about 92% (6S)-leucovorin and specified (6R) balance; claim 1 is tied to methotrexate rescue/folate deficiency and other independent claims impose multidose quantity/purity conditions. No standalone broad compound claim or all-indication clinical method is established; do not upgrade the DS listing automatically. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| I-637 | 2011-04-29 | 2014-04-29 | I-637 and ODE ending 2018-04-29 protect colorectal-cancer combination treatment only. The 2015-03-07 ODE is associated with methotrexate rescue/toxicity uses. Together their approved-label indications span all three labeled uses until 2015-03-07; this is an inferred combination, not independently certified protected-indication scope: the pre-2013 FDA registry has no populated protected-indication field. Do not promote 2018-04-29 to a full-scope date. | N | N | — | ODE:2015-03-07 + ODE/ODE-10:2018-04-29
Full coverage date: —
| Source |
| ODE | 2008-03-07 | 2015-03-07 | I-637 and ODE ending 2018-04-29 protect colorectal-cancer combination treatment only. The 2015-03-07 ODE is associated with methotrexate rescue/toxicity uses. Together their approved-label indications span all three labeled uses until 2015-03-07; this is an inferred combination, not independently certified protected-indication scope: the pre-2013 FDA registry has no populated protected-indication field. Do not promote 2018-04-29 to a full-scope date. | N | N | — | ODE:2015-03-07 + ODE/ODE-10:2018-04-29
Full coverage date: —
| Source |
| ODE | 2011-04-29 | 2018-04-29 | I-637 and ODE ending 2018-04-29 protect colorectal-cancer combination treatment only. The 2015-03-07 ODE is associated with methotrexate rescue/toxicity uses. Together their approved-label indications span all three labeled uses until 2015-03-07; this is an inferred combination, not independently certified protected-indication scope: the pre-2013 FDA registry has no populated protected-indication field. Do not promote 2018-04-29 to a full-scope date. | N | N | — | ODE:2015-03-07 + ODE/ODE-10:2018-04-29
Full coverage date: —
| 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 (5)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2022-03-07 | FTO_TAIL | Pharmaceutical compositions with at least about 92% (6S)-leucovorin and specified (6R) balance; claim 1 is tied to methotrexate rescue/folate deficiency and other independent claims impose multidose quantity/purity conditions. No standalone broad compound claim or all-indication clinical method is established; do not upgrade the DS listing automatically. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | I-637 and ODE ending 2018-04-29 protect colorectal-cancer combination treatment only. The 2015-03-07 ODE is associated with methotrexate rescue/toxicity uses. Together their approved-label indications span all three labeled uses until 2015-03-07; this is an inferred combination, not independently certified protected-indication scope: the pre-2013 FDA registry has no populated protected-indication field. Do not promote 2018-04-29 to a full-scope date. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | I-637 and ODE ending 2018-04-29 protect colorectal-cancer combination treatment only. The 2015-03-07 ODE is associated with methotrexate rescue/toxicity uses. Together their approved-label indications span all three labeled uses until 2015-03-07; this is an inferred combination, not independently certified protected-indication scope: the pre-2013 FDA registry has no populated protected-indication field. Do not promote 2018-04-29 to a full-scope date. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | I-637 and ODE ending 2018-04-29 protect colorectal-cancer combination treatment only. The 2015-03-07 ODE is associated with methotrexate rescue/toxicity uses. Together their approved-label indications span all three labeled uses until 2015-03-07; this is an inferred combination, not independently certified protected-indication scope: the pre-2013 FDA registry has no populated protected-indication field. Do not promote 2018-04-29 to a full-scope date. | Source |
| REGULATORY_STATUS | 2026-08-05 | TERMINAL_STATUS | FDA_APPROVAL_WITHDRAWAL; canonical rights assessment 2011 DEEP_REVIEW; APPROVAL_YEAR_FALLBACK. | 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.