LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
· 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. Retrieved Final approval letters for linezolid candidates 204764 and 205154 reference ZYVOX, not NDA 206473. Other matching candidates lack accessible reference letters. Direct-reference evidence is insufficient for EG; DR is retained. Evidence limitation: FDA source documents identifying the direct RLD for remaining matching ANDA candidates.
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 |
|---|---|---|---|---|---|---|---|
| 200222 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2012-06-27 | — | TEVA PHARMACEUTICALS USA | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 205442 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2015-07-07 | — | HOSPIRA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 200904 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2015-07-16 | — | SANDOZ INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 204764 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2016-03-15 | — | FRESENIUS KABI USA LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 206917 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2016-08-04 | — | EUGIA PHARMA SPECIALITIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 207354 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2016-12-20 | — | NANG KUANG PHARMACEUTICAL CO LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 204696 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2017-03-02 | — | SAGENT PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 207001 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2017-07-07 | — | HQ SPECIALTY PHARMA CORP | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 205154 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2017-12-06 | — | SEROVIA HOLDINGS LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 206454 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2022-08-22 | — | HIKMA PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 219558 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2025-12-08 | — | CAPLIN STERILES 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 11 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 |
|---|---|---|---|---|---|---|
| 200222 / 001 | TEVA PHARMACEUTICALS USA | FINAL_APPROVAL · FINAL_APPROVED | 2012-06-27 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 205442 / 001 | HOSPIRA INC | FINAL_APPROVAL · FINAL_APPROVED | 2015-07-07 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 200904 / 002 | SANDOZ INC | FINAL_APPROVAL · FINAL_APPROVED | 2015-07-16 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 204764 / 001 | FRESENIUS KABI USA LLC | FINAL_APPROVAL · FINAL_APPROVED | 2016-03-15 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 206917 / 001 | EUGIA PHARMA SPECIALITIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2016-08-04 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 207354 / 002 | NANG KUANG PHARMACEUTICAL CO LTD | FINAL_APPROVAL · FINAL_APPROVED | 2016-12-20 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 204696 / 002 | SAGENT PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2017-03-02 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 207001 / 002 | HQ SPECIALTY PHARMA CORP | FINAL_APPROVAL · FINAL_APPROVED | 2017-07-07 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 205154 / 002 | SEROVIA HOLDINGS LTD | FINAL_APPROVAL · FINAL_APPROVED | 2017-12-06 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 206454 / 001 | HIKMA PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2022-08-22 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 219558 / 001 | CAPLIN STERILES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2025-12-08 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (1)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| REGULATORY_STATUS | 2015-06-18 | 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. Retrieved Final approval letters for linezolid candidates 204764 and 205154 reference ZYVOX, not NDA 206473. Other matching candidates lack accessible reference letters. Direct-reference evidence is insufficient for EG; DR is retained. Evidence limitation: FDA source documents identifying the direct RLD for remaining matching ANDA candidates. | 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.