VYKOURA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
No verified direct-reference Final ANDA or unrestricted TrueDS/DS-equivalent/full-coverage exclusivity anchor is established for this exact product. Apply the approval-year DR fallback under the review policy. All matching leucovorin ANDAs were approved before VYKOURA NDA 220406 in 2026. FDA letters 040332 and 040347 establish older ready-to-use/suitability-petition products. They cannot reference the subsequently approved VYKOURA product.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 12564592 | 2044-12-23 | DP — | N | N | CYCLODEXTRIN_LEUCOVORIN_INJECTION | — | — | — |
| 12564592 | 2044-12-23 | DP — | N | N | CYCLODEXTRIN_LEUCOVORIN_INJECTION Claim 1 requires a leucovorin-calcium/cyclodextrin complex with specified concentrations, ratio, pH, osmolality, storage stability and ready-to-use administration properties. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| No exclusivity facts are recorded in this product snapshot. | ||||||||
2026-10-11 · CURRENT_SNAPSHOT_NO_RECORD · Historical coverage: NOT_COMPLETE
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 |
|---|---|---|---|---|---|---|---|
| 040332 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 1999-06-28 | — | TEVA PARENTERAL MEDICINES INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 040347 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2000-04-25 | — | HIKMA PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 207226 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2018-07-27 | — | FRESENIUS KABI USA LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210917 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2018-11-23 | — | INGENUS PHARMACEUTICALS LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
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 4 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 |
|---|---|---|---|---|---|---|
| 040332 / 001 | TEVA PARENTERAL MEDICINES INC | FINAL_APPROVAL · FINAL_APPROVED | 1999-06-28 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 040347 / 002 | HIKMA PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2000-04-25 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 207226 / 001 | FRESENIUS KABI USA LLC | FINAL_APPROVAL · FINAL_APPROVED | 2018-07-27 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210917 / 001 | INGENUS PHARMACEUTICALS LLC | FINAL_APPROVAL · FINAL_APPROVED | 2018-11-23 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (2)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2044-12-23 | FTO_TAIL | Claim 1 requires a leucovorin-calcium/cyclodextrin complex with specified concentrations, ratio, pH, osmolality, storage stability and ready-to-use administration properties. | Source |
| REGULATORY_STATUS | 2026-02-03 | DECISION_BASIS | No verified direct-reference Final ANDA or unrestricted TrueDS/DS-equivalent/full-coverage exclusivity anchor is established for this exact product. Apply the approval-year DR fallback under the review policy. All matching leucovorin ANDAs were approved before VYKOURA NDA 220406 in 2026. FDA letters 040332 and 040347 establish older ready-to-use/suitability-petition products. They cannot reference the subsequently approved VYKOURA product. | Source |
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.