Product profile · United States
NOXAFIL
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Current FDA Orange Book lists the exact product as discontinued. The actual discontinuation date is not established and is kept null; approval and observation dates are not substituted. Current FDA Orange Book lists the exact product as discontinued. The actual discontinuation date is not established and is kept null; approval and observation dates are not substituted.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10117951 | 2029-03-13 | DP — | N | N | EXCIPIENT_QUALITY_COMPOSITION | — | — | — |
| 10117951 | 2029-03-13 | DP — | N | N | EXCIPIENT_QUALITY_COMPOSITION Independent claims concern sulfoalkyl ether cyclodextrin quality, phosphate/impurity or UV absorption limits. The claimed excipient is not posaconazole drug substance. | — | — | — |
| 8410077 | 2029-03-13 | DP — | N | N | EXCIPIENT_QUALITY_COMPOSITION | — | — | — |
| 8410077 | 2029-03-13 | DP — | N | N | EXCIPIENT_QUALITY_COMPOSITION Independent claims concern sulfoalkyl ether cyclodextrin quality, phosphate/impurity or UV absorption limits. The claimed excipient is not posaconazole drug substance. | — | — | — |
| 9750822 | 2029-03-13 | DP — | N | N | EXCIPIENT_QUALITY_COMPOSITION | — | — | — |
| 9750822 | 2029-03-13 | DP — | N | N | EXCIPIENT_QUALITY_COMPOSITION Independent claims concern sulfoalkyl ether cyclodextrin quality, phosphate/impurity or UV absorption limits. The claimed excipient is not posaconazole drug substance. | — | — | — |
| 9358297 | 2031-06-24 | DP/U U-3171 | N | N | INTRAVENOUS_FORMULATION | — | — | — |
| 9358297 | 2031-06-24 | DP/U U-4415 | N | N | INTRAVENOUS_FORMULATION | — | — | — |
| 9358297 | 2031-06-24 | DP/U U-4416 | N | N | INTRAVENOUS_FORMULATION | — | — | — |
| 9358297 | 2031-06-24 | DP/U U-3160 | N | N | INTRAVENOUS_FORMULATION | — | — | — |
| 9358297 | 2031-06-24 | DP/U U-3160 | N | N | INTRAVENOUS_FORMULATION Independent claims restrict intravenous posaconazole to specified sulfobutylether cyclodextrin, pH and component concentrations; they do not claim posaconazole without formulation restrictions. | — | — | — |
| 9358297 | 2031-06-24 | DP/U U-3171 | N | N | INTRAVENOUS_FORMULATION Independent claims restrict intravenous posaconazole to specified sulfobutylether cyclodextrin, pH and component concentrations; they do not claim posaconazole without formulation restrictions. | — | — | — |
| 9358297 | 2031-06-24 | DP/U U-4415 | N | N | INTRAVENOUS_FORMULATION Independent claims restrict intravenous posaconazole to specified sulfobutylether cyclodextrin, pH and component concentrations; they do not claim posaconazole without formulation restrictions. | — | — | — |
| 9358297 | 2031-06-24 | DP/U U-4416 | N | N | INTRAVENOUS_FORMULATION Independent claims restrict intravenous posaconazole to specified sulfobutylether cyclodextrin, pH and component concentrations; they do not claim posaconazole without formulation restrictions. | — | — | — |
| 9023790 | 2031-07-04 | DP/U U-3171 | N | N | INTRAVENOUS_FORMULATION | — | — | — |
| 9023790 | 2031-07-04 | DP/U U-4415 | N | N | INTRAVENOUS_FORMULATION | — | — | — |
| 9023790 | 2031-07-04 | DP/U U-1698 | N | N | INTRAVENOUS_FORMULATION | — | — | — |
| 9023790 | 2031-07-04 | DP/U U-3160 | N | N | INTRAVENOUS_FORMULATION | — | — | — |
| 9023790 | 2031-07-04 | DP/U U-4416 | N | N | INTRAVENOUS_FORMULATION | — | — | — |
| 9023790 | 2031-07-04 | DP/U U-3171 | N | N | INTRAVENOUS_FORMULATION Independent claims restrict intravenous posaconazole to specified sulfobutylether cyclodextrin, pH and component concentrations; they do not claim posaconazole without formulation restrictions. | — | — | — |
| 9023790 | 2031-07-04 | DP/U U-4415 | N | N | INTRAVENOUS_FORMULATION Independent claims restrict intravenous posaconazole to specified sulfobutylether cyclodextrin, pH and component concentrations; they do not claim posaconazole without formulation restrictions. | — | — | — |
| 9023790 | 2031-07-04 | DP/U U-3160 | N | N | INTRAVENOUS_FORMULATION Independent claims restrict intravenous posaconazole to specified sulfobutylether cyclodextrin, pH and component concentrations; they do not claim posaconazole without formulation restrictions. | — | — | — |
| 9023790 | 2031-07-04 | DP/U U-4416 | N | N | INTRAVENOUS_FORMULATION Independent claims restrict intravenous posaconazole to specified sulfobutylether cyclodextrin, pH and component concentrations; they do not claim posaconazole without formulation restrictions. | — | — | — |
| 9023790 | 2031-07-04 | DP/U U-1698 | N | N | INTRAVENOUS_FORMULATION Independent claims restrict intravenous posaconazole to specified sulfobutylether cyclodextrin, pH and component concentrations; they do not claim posaconazole without formulation restrictions. | — | — | — |
| 9493582 | 2033-02-27 | DP — | N | N | EXCIPIENT_PURIFICATION_PROCESS | — | — | — |
| 9493582 | 2033-02-27 | DP — | N | N | EXCIPIENT_PURIFICATION_PROCESS Claim 1 requires cyclodextrin alkylation, specified separations and phosphate-free activated carbon purification. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| ODE-355 | 2021-06-17 | 2028-06-17 | Invasive aspergillosis treatment in adults and patients at least 13 years old; prophylaxis indication remains outside this scope. | N | N | — | NPP + ODE-355
Full coverage date: —
| Source |
| ODE-355 | 2021-06-17 | 2028-06-17 | Invasive aspergillosis treatment in adults and patients at least 13 years old; prophylaxis indication remains outside this scope. | N | N | — | NPP + ODE-355
Full coverage date: —
| Source |
| NPP | 2026-01-27 | 2029-01-27 | Treatment of invasive aspergillosis expanded to pediatric patients aged 2 to less than 13 years and weighing at least 10 kg for intravenous injection; existing prophylaxis is not covered. | N | N | — | NPP + ODE-355
Full coverage date: —
| Source |
| NPP | 2026-01-27 | 2029-01-27 | Treatment of invasive aspergillosis expanded to pediatric patients aged 2 to less than 13 years and weighing at least 10 kg for intravenous injection; existing prophylaxis is not covered. | N | N | — | NPP + ODE-355
Full coverage date: —
| Source |
2026-10-11 · CURRENT_SNAPSHOT_RECORDS · Historical coverage: NOT_COMPLETE
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 |
|---|---|---|---|---|---|---|---|
| 208768 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2022-05-25 | — | PH HEALTH LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 209983 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2023-12-26 | — | FRESENIUS KABI USA LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211500 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2023-12-26 | — | MYLAN LABORATORIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 214842 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2023-12-26 | — | EUGIA PHARMA SPECIALITIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 217553 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2023-12-26 | — | GLAND PHARMA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 219057 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2024-12-23 | — | ASPIRO PHARMA LTD | 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 6 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 |
|---|---|---|---|---|---|---|
| 208768 / 001 | PH HEALTH LTD | FINAL_APPROVAL · FINAL_APPROVED | 2022-05-25 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 209983 / 001 | FRESENIUS KABI USA LLC | FINAL_APPROVAL · FINAL_APPROVED | 2023-12-26 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211500 / 001 | MYLAN LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2023-12-26 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 214842 / 001 | EUGIA PHARMA SPECIALITIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2023-12-26 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 217553 / 001 | GLAND PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2023-12-26 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 219057 / 001 | ASPIRO PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2024-12-23 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (16)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2029-03-13 | FTO_TAIL | Independent claims concern sulfoalkyl ether cyclodextrin quality, phosphate/impurity or UV absorption limits. The claimed excipient is not posaconazole drug substance. | Source |
| PATENT | 2029-03-13 | FTO_TAIL | Independent claims concern sulfoalkyl ether cyclodextrin quality, phosphate/impurity or UV absorption limits. The claimed excipient is not posaconazole drug substance. | Source |
| PATENT | 2029-03-13 | FTO_TAIL | Independent claims concern sulfoalkyl ether cyclodextrin quality, phosphate/impurity or UV absorption limits. The claimed excipient is not posaconazole drug substance. | Source |
| PATENT | 2031-06-24 | FTO_TAIL | Independent claims restrict intravenous posaconazole to specified sulfobutylether cyclodextrin, pH and component concentrations; they do not claim posaconazole without formulation restrictions. | Source |
| PATENT | 2031-06-24 | FTO_TAIL | Independent claims restrict intravenous posaconazole to specified sulfobutylether cyclodextrin, pH and component concentrations; they do not claim posaconazole without formulation restrictions. | Source |
| PATENT | 2031-06-24 | FTO_TAIL | Independent claims restrict intravenous posaconazole to specified sulfobutylether cyclodextrin, pH and component concentrations; they do not claim posaconazole without formulation restrictions. | Source |
| PATENT | 2031-06-24 | FTO_TAIL | Independent claims restrict intravenous posaconazole to specified sulfobutylether cyclodextrin, pH and component concentrations; they do not claim posaconazole without formulation restrictions. | Source |
| PATENT | 2031-07-04 | FTO_TAIL | Independent claims restrict intravenous posaconazole to specified sulfobutylether cyclodextrin, pH and component concentrations; they do not claim posaconazole without formulation restrictions. | Source |
| PATENT | 2031-07-04 | FTO_TAIL | Independent claims restrict intravenous posaconazole to specified sulfobutylether cyclodextrin, pH and component concentrations; they do not claim posaconazole without formulation restrictions. | Source |
| PATENT | 2031-07-04 | FTO_TAIL | Independent claims restrict intravenous posaconazole to specified sulfobutylether cyclodextrin, pH and component concentrations; they do not claim posaconazole without formulation restrictions. | Source |
| PATENT | 2031-07-04 | FTO_TAIL | Independent claims restrict intravenous posaconazole to specified sulfobutylether cyclodextrin, pH and component concentrations; they do not claim posaconazole without formulation restrictions. | Source |
| PATENT | 2031-07-04 | FTO_TAIL | Independent claims restrict intravenous posaconazole to specified sulfobutylether cyclodextrin, pH and component concentrations; they do not claim posaconazole without formulation restrictions. | Source |
| PATENT | 2033-02-27 | FTO_TAIL | Claim 1 requires cyclodextrin alkylation, specified separations and phosphate-free activated carbon purification. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Invasive aspergillosis treatment in adults and patients at least 13 years old; prophylaxis indication remains outside this scope. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Treatment of invasive aspergillosis expanded to pediatric patients aged 2 to less than 13 years and weighing at least 10 kg for intravenous injection; existing prophylaxis is not covered. | Source |
| REGULATORY_STATUS | — | TERMINAL_STATUS | Current FDA Orange Book lists the exact product as discontinued. The actual discontinuation date is not established and is kept null; approval and observation dates are not substituted. Current FDA Orange Book lists the exact product as discontinued. The actual discontinuation date is not established and is kept null; approval and observation dates are not substituted. | 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.