Product profile · United States
NAVITRUX
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
No verified direct-reference Final ANDA or unrestricted DS/DS-equivalent/full-coverage exclusivity anchor is established for this exact product. Apply the approval-year DR fallback under the review policy. New NAVITRUX NDA 220436 approved June 24, 2026. EMEND-referencing fosaprepitant ANDAs are not transferred to this separate formulation.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| No patent facts are recorded for this product. | ||||||||
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 |
|---|---|---|---|---|---|---|---|
| 206197 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2016-06-09 | — | FRESENIUS KABI USA LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 204015 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2019-09-05 | — | MYLAN LABORATORIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 205020 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2019-09-05 | — | APOTEX INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 209965 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2019-09-05 | — | MSN LABORATORIES PRIVATE LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210689 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2019-09-05 | — | LUPIN LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211624 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2019-09-05 | — | GENEYORK PHARMACEUTICALS GROUP LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211860 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2019-09-05 | — | BAXTER HEALTHCARE CORP | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212309 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2019-09-05 | — | BE PHARMACEUTICALS AG | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212957 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2020-08-20 | — | CHARTWELL RX SCIENCES LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 204025 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2020-08-26 | — | ACCORD HEALTHCARE INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 213106 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2020-09-08 | — | QILU PHARMACEUTICAL HAINAN CO LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 203939 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2020-12-08 | — | CAPLIN STERILES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211160 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2020-12-09 | — | DR REDDYS LABORATORIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210625 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2021-01-12 | — | EUGIA PHARMA SPECIALITIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212143 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2021-03-03 | — | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 214616 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2021-07-29 | — | ASPIRO PHARMA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 213199 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2021-10-04 | — | PRAXGEN PHARMACEUTICALS LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 214683 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2023-05-16 | — | PIRAMAL CRITICAL CARE INC | 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 18 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 |
|---|---|---|---|---|---|---|
| 206197 / 001 | FRESENIUS KABI USA LLC | FINAL_APPROVAL · FINAL_APPROVED | 2016-06-09 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 204015 / 002 | MYLAN LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2019-09-05 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 205020 / 001 | APOTEX INC | FINAL_APPROVAL · FINAL_APPROVED | 2019-09-05 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 209965 / 001 | MSN LABORATORIES PRIVATE LTD | FINAL_APPROVAL · FINAL_APPROVED | 2019-09-05 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210689 / 001 | LUPIN LTD | FINAL_APPROVAL · FINAL_APPROVED | 2019-09-05 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211624 / 001 | GENEYORK PHARMACEUTICALS GROUP LLC | FINAL_APPROVAL · FINAL_APPROVED | 2019-09-05 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211860 / 001 | BAXTER HEALTHCARE CORP | FINAL_APPROVAL · FINAL_APPROVED | 2019-09-05 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 212309 / 001 | BE PHARMACEUTICALS AG | FINAL_APPROVAL · FINAL_APPROVED | 2019-09-05 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 212957 / 002 | CHARTWELL RX SCIENCES LLC | FINAL_APPROVAL · FINAL_APPROVED | 2020-08-20 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 204025 / 001 | ACCORD HEALTHCARE INC | FINAL_APPROVAL · FINAL_APPROVED | 2020-08-26 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 213106 / 001 | QILU PHARMACEUTICAL HAINAN CO LTD | FINAL_APPROVAL · FINAL_APPROVED | 2020-09-08 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 203939 / 001 | CAPLIN STERILES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2020-12-08 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211160 / 001 | DR REDDYS LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2020-12-09 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210625 / 001 | EUGIA PHARMA SPECIALITIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2021-01-12 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 212143 / 001 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO LTD | FINAL_APPROVAL · FINAL_APPROVED | 2021-03-03 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 214616 / 001 | ASPIRO PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2021-07-29 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 213199 / 001 | PRAXGEN PHARMACEUTICALS LLC | FINAL_APPROVAL · FINAL_APPROVED | 2021-10-04 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 214683 / 001 | PIRAMAL CRITICAL CARE INC | FINAL_APPROVAL · FINAL_APPROVED | 2023-05-16 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (1)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| REGULATORY_STATUS | 2026-06-24 | DECISION_BASIS | No verified direct-reference Final ANDA or unrestricted DS/DS-equivalent/full-coverage exclusivity anchor is established for this exact product. Apply the approval-year DR fallback under the review policy. New NAVITRUX NDA 220436 approved June 24, 2026. EMEND-referencing fosaprepitant ANDAs are not transferred to this separate formulation. | 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.