SODIUM CHLORIDE 0.9%
· 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. Product 005 is the B. Braun 10 mL presentation. FDA letters 203352 and 217535 identify Hospira reference products, not this B. Braun product. Other AP-rated candidates cannot be assigned to the B. Braun presentation from ingredient/strength matching alone.
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 |
|---|---|---|---|---|---|---|---|
| 088912 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 1985-01-10 | — | FRESENIUS KABI USA LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 088909 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 1985-05-15 | — | ABRAXIS PHARMACEUTICAL PRODUCTS | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 088911 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 1985-05-17 | — | FRESENIUS KABI USA LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 077407 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2006-08-11 | — | TARO PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 201850 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2012-01-20 | — | HIKMA PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 201833 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2015-01-07 | — | HIKMA PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 203352 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2016-05-18 | — | JUBILANT CADISTA PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 206171 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2017-07-21 | — | SPECTRA MEDICAL DEVICES INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 217535 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2023-08-23 | — | NEXUS 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 9 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 |
|---|---|---|---|---|---|---|
| 088912 / 001 | FRESENIUS KABI USA LLC | FINAL_APPROVAL · FINAL_APPROVED | 1985-01-10 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 088909 / 002 | ABRAXIS PHARMACEUTICAL PRODUCTS | FINAL_APPROVAL · FINAL_APPROVED | 1985-05-15 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 088911 / 002 | FRESENIUS KABI USA LLC | FINAL_APPROVAL · FINAL_APPROVED | 1985-05-17 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 077407 / 002 | TARO PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2006-08-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 201850 / 001 | HIKMA PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2012-01-20 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 201833 / 002 | HIKMA PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2015-01-07 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 203352 / 001 | JUBILANT CADISTA PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2016-05-18 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 206171 / 002 | SPECTRA MEDICAL DEVICES INC | FINAL_APPROVAL · FINAL_APPROVED | 2017-07-21 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 217535 / 001 | NEXUS PHARMACEUTICALS LLC | FINAL_APPROVAL · FINAL_APPROVED | 2023-08-23 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (1)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| REGULATORY_STATUS | 2016-08-08 | 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. Product 005 is the B. Braun 10 mL presentation. FDA letters 203352 and 217535 identify Hospira reference products, not this B. Braun product. Other AP-rated candidates cannot be assigned to the B. Braun presentation from ingredient/strength matching alone. | 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.