NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
· 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. A ready-to-administer saline premix under a distinct NDA. Dextrose-referencing or other-NDA ANDAs are not transferred. Listed patents are formulation, packaging or process restricted and supply no DS-equivalent anchor.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10159657 | 2038-01-30 | DP — | N | N | READY_TO_ADMINISTER_FORMULATION | — | — | — |
| 10159657 | 2038-01-30 | DP — | N | N | READY_TO_ADMINISTER_FORMULATION Claim 1 restricts norepinephrine concentration, chelator, salt, pH, antioxidant absence, and stability. | — | — | — |
| 10226436 | 2038-01-30 | DP/U U-3461 | N | N | READY_TO_ADMINISTER_FORMULATION | — | — | — |
| 10226436 | 2038-01-30 | DP/U U-3461 | N | N | READY_TO_ADMINISTER_FORMULATION Claim 1 requires an acidic aqueous norepinephrine solution with chelator and salt concentrations, antioxidant absence, and isomerization/degradation limits. | — | — | — |
| 10420735 | 2038-01-30 | DP/U U-3461 | N | N | FORMULATION_RESTRICTED_DOSING | — | — | — |
| 10420735 | 2038-01-30 | DP/U U-3461 | N | N | FORMULATION_RESTRICTED_DOSING Claim 1 restricts hypotension treatment to specified initial and maintenance doses of a chelator-containing stable premix. | — | — | — |
| 10568850 | 2038-01-30 | DP — | N | N | PACKAGED_FORMULATION | — | — | — |
| 10568850 | 2038-01-30 | DP — | N | N | PACKAGED_FORMULATION Claim 1 restricts sterile norepinephrine to primary and secondary packaging, excipient concentrations, pH, and stability. | — | — | — |
| 11413259 | 2038-01-30 | DP/U U-3461 | N | N | FORMULATION_PREPARATION_PROCESS | — | — | — |
| 11413259 | 2038-01-30 | DP/U U-3461 | N | N | FORMULATION_PREPARATION_PROCESS Claim 1 requires admixing norepinephrine with specified chelator and salt amounts and adjusting pH to produce a stable antioxidant-free premix. | — | — | — |
| 11602508 | 2038-01-30 | DP — | N | N | READY_TO_ADMINISTER_FORMULATION | — | — | — |
| 11602508 | 2038-01-30 | DP — | N | N | READY_TO_ADMINISTER_FORMULATION Claim 1 requires a tartrate bicarboxylic acid chelator, a tonicity agent, specified pH and R-isomer stability. | — | — | — |
| 12245996 | 2038-01-30 | DP — | N | N | READY_TO_INJECT_FORMULATION | — | — | — |
| 12245996 | 2038-01-30 | DP — | N | N | READY_TO_INJECT_FORMULATION Claim 1 restricts concentration, R-isomer content, a bicarboxylic acid metal-ion chelator, tonicity agents, pH, and antioxidant absence. | — | — | — |
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 |
|---|---|---|---|---|---|---|---|
| 219692 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2025-08-11 | — | SAGENT PHARMACEUTICALS | 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 1 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 |
|---|---|---|---|---|---|---|
| 219692 / 001 | SAGENT PHARMACEUTICALS | FINAL_APPROVAL · FINAL_APPROVED | 2025-08-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (8)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2038-01-30 | FTO_TAIL | Claim 1 restricts hypotension treatment to specified initial and maintenance doses of a chelator-containing stable premix. | Source |
| PATENT | 2038-01-30 | FTO_TAIL | Claim 1 requires a tartrate bicarboxylic acid chelator, a tonicity agent, specified pH and R-isomer stability. | Source |
| PATENT | 2038-01-30 | FTO_TAIL | Claim 1 restricts concentration, R-isomer content, a bicarboxylic acid metal-ion chelator, tonicity agents, pH, and antioxidant absence. | Source |
| PATENT | 2038-01-30 | FTO_TAIL | Claim 1 requires an acidic aqueous norepinephrine solution with chelator and salt concentrations, antioxidant absence, and isomerization/degradation limits. | Source |
| PATENT | 2038-01-30 | FTO_TAIL | Claim 1 restricts sterile norepinephrine to primary and secondary packaging, excipient concentrations, pH, and stability. | Source |
| PATENT | 2038-01-30 | FTO_TAIL | Claim 1 requires admixing norepinephrine with specified chelator and salt amounts and adjusting pH to produce a stable antioxidant-free premix. | Source |
| PATENT | 2038-01-30 | FTO_TAIL | Claim 1 restricts norepinephrine concentration, chelator, salt, pH, antioxidant absence, and stability. | Source |
| REGULATORY_STATUS | 2022-10-06 | 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. A ready-to-administer saline premix under a distinct NDA. Dextrose-referencing or other-NDA ANDAs are not transferred. Listed patents are formulation, packaging or process restricted and supply no DS-equivalent anchor. | 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.