Product profile · United States
ZERBAXA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Canonical 2028-11-15; DEEP_REVIEW; latest post-anchor right 2036-02-14; Final exact ANDA link not identified; not certified generic absence.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 7129232 | 2028-05-15 | DS/DP/U U-1676 | — | — | — | — | — | — |
| 7129232 | 2028-05-15 | DS/DP/U U-3360 | — | — | — | — | — | — |
| 7129232 | 2028-05-15 | DS/DP/U U-4542 | — | — | — | — | — | — |
| 7129232 | 2028-05-15 | DS/DP/U U-4543 | — | — | — | — | — | — |
| 7129232 | 2028-05-15 | DS/DP/U U-4550 | — | — | — | — | — | — |
| 7129232 | 2028-05-15 | DS/DP/U U-3361 | — | — | — | — | — | — |
| 7129232 | 2028-05-15 | DS/DP/U U-36 | — | — | — | — | — | — |
| 7129232 | 2028-05-15 | DS/DP/U U-4547 | — | — | — | — | — | — |
| 7129232 | 2028-11-15 | — — | — | — | — | — | 2028-11-15 | — |
| 7129232 | 2028-11-15 | ORANGE_BOOK U-1676,U-3360,U-3361,U-36,U-4542,U-4543,U-4547,U-4550 | Y | N | TRUE_DS English description not available. | — | 2028-11-15 | — |
| 10028963 | 2032-09-07 | U U-2565 | — | — | — | — | — | — |
| 10028963 | 2032-09-07 | U U-2566 | — | — | — | — | — | — |
| 10028963 | 2032-09-07 | U U-4542 | — | — | — | — | — | — |
| 10028963 | 2032-09-07 | U U-4543 | — | — | — | — | — | — |
| 9724353 | 2032-09-07 | U U-2566 | — | — | — | — | — | — |
| 9724353 | 2032-09-07 | U U-4543 | — | — | — | — | — | — |
| 9724353 | 2032-09-07 | U U-2565 | — | — | — | — | — | — |
| 9724353 | 2032-09-07 | U U-4542 | — | — | — | — | — | — |
| 10028963 | 2033-03-07 | — — | — | — | — | — | 2033-03-07 | — |
| 10028963 | 2033-03-07 | ORANGE_BOOK U-2565,U-2566,U-4542,U-4543 | N | N | U English description not available. | — | 2033-03-07 | — |
| 9724353 | 2033-03-07 | — — | — | — | — | — | 2033-03-07 | — |
| 9724353 | 2033-03-07 | ORANGE_BOOK U-2565,U-2566,U-4542,U-4543 | N | N | U English description not available. | — | 2033-03-07 | — |
| 10420841 | 2034-03-14 | U U-3360 | — | — | — | — | — | — |
| 10420841 | 2034-03-14 | U U-3361 | — | — | — | — | — | — |
| 10420841 | 2034-03-14 | U U-4547 | — | — | — | — | — | — |
| 10420841 | 2034-03-14 | U U-4546 | — | — | — | — | — | — |
| 10420841 | 2034-03-14 | U U-2631 | — | — | — | — | — | — |
| 10420841 | 2034-03-14 | U U-1672 | — | — | — | — | — | — |
| 11278622 | 2034-03-14 | U U-4543 | — | — | — | — | — | — |
| 11278622 | 2034-03-14 | U U-3335 | — | — | — | — | — | — |
| 11278622 | 2034-03-14 | U U-3336 | — | — | — | — | — | — |
| 11278622 | 2034-03-14 | U U-4542 | — | — | — | — | — | — |
| 8968753 | 2034-03-14 | U U-1673 | — | — | — | — | — | — |
| 8968753 | 2034-03-14 | U U-3361 | — | — | — | — | — | — |
| 8968753 | 2034-03-14 | U U-3360 | — | — | — | — | — | — |
| 8968753 | 2034-03-14 | U U-4547 | — | — | — | — | — | — |
| 8968753 | 2034-03-14 | U U-1672 | — | — | — | — | — | — |
| 8968753 | 2034-03-14 | U U-4550 | — | — | — | — | — | — |
| 9320740 | 2034-03-14 | DP — | — | — | — | — | — | — |
| 9872906 | 2034-03-14 | DP — | — | — | — | — | — | — |
| 8906898 | 2034-05-28 | DS/DP — | — | — | — | — | — | — |
| 10376496 | 2034-09-09 | U U-4549 | — | — | — | — | — | — |
| 10376496 | 2034-09-09 | U U-4548 | — | — | — | — | — | — |
| 10376496 | 2034-09-09 | U U-2610 | — | — | — | — | — | — |
| 10376496 | 2034-09-09 | U U-2611 | — | — | — | — | — | — |
| 10933053 | 2034-09-09 | U U-3090 | — | — | — | — | — | — |
| 10933053 | 2034-09-09 | U U-4545 | — | — | — | — | — | — |
| 10933053 | 2034-09-09 | U U-4544 | — | — | — | — | — | — |
| 10933053 | 2034-09-09 | U U-3091 | — | — | — | — | — | — |
| 10420841 | 2034-09-14 | — — | — | — | — | — | 2034-09-14 | — |
| 10420841 | 2034-09-14 | ORANGE_BOOK U-1672,U-2631,U-3360,U-3361,U-4546,U-4547 | N | N | U English description not available. | — | 2034-09-14 | — |
| 11278622 | 2034-09-14 | — — | — | — | — | — | 2034-09-14 | — |
| 11278622 | 2034-09-14 | ORANGE_BOOK U-3335,U-3336,U-4542,U-4543 | N | N | U English description not available. | — | 2034-09-14 | — |
| 8968753 | 2034-09-14 | — — | — | — | — | — | 2034-09-14 | — |
| 8968753 | 2034-09-14 | ORANGE_BOOK U-1672,U-1673,U-3360,U-3361,U-4547,U-4550 | N | N | U English description not available. | — | 2034-09-14 | — |
| 9320740 | 2034-09-14 | — — | — | — | — | — | 2034-09-14 | — |
| 9320740 | 2034-09-14 | ORANGE_BOOK — | N | N | DP English description not available. | — | 2034-09-14 | — |
| 9872906 | 2034-09-14 | — — | — | — | — | — | 2034-09-14 | — |
| 9872906 | 2034-09-14 | ORANGE_BOOK — | N | N | DP English description not available. | — | 2034-09-14 | — |
| 8906898 | 2034-11-28 | — — | — | — | — | — | 2034-11-28 | — |
| 8906898 | 2034-11-28 | ORANGE_BOOK — | N | N | DP English description not available. | — | 2034-11-28 | — |
| 10376496 | 2035-03-09 | — — | — | — | — | — | 2035-03-09 | — |
| 10376496 | 2035-03-09 | ORANGE_BOOK U-2610,U-2611,U-4548,U-4549 | N | N | U English description not available. | — | 2035-03-09 | — |
| 10933053 | 2035-03-09 | — — | — | — | — | — | 2035-03-09 | — |
| 10933053 | 2035-03-09 | ORANGE_BOOK U-3090,U-3091,U-4544,U-4545 | N | N | U English description not available. | — | 2035-03-09 | — |
| 10125149 | 2035-08-14 | DP — | — | — | — | — | — | — |
| 10125149 | 2036-02-14 | — — | — | — | — | — | 2036-02-14 | — |
| 10125149 | 2036-02-14 | ORANGE_BOOK — | N | N | DP English description not available. | — | 2036-02-14 | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2014-12-19 | 2019-12-19 | English description not available. | Y | Y | — | Source | |
| GAIN | 2019-12-19 | 2024-12-19 | English description not available. | Y | Y | — | Source | |
| NPP | 2022-04-21 | 2025-04-21 | English description not available. | N | N | — | Source | |
| NPP | — | 2029-05-12 | — | — | — | — | Source | |
| NPP | 2026-05-12 | 2029-05-12 | English description not available. | N | N | — | Source | |
| PED | — | 2029-11-12 | — | — | — | — | Source | |
| PED | 2029-05-12 | 2029-11-12 | English description not available. | N | N | — | Source |
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 |
|---|---|---|---|---|---|---|---|
| No generic approval facts are linked to this product. | |||||||
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 0 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 |
|---|---|---|---|---|---|---|
| No final-approval records are linked to this product. | ||||||
Decision evidence (18)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2028-11-15 | CANONICAL_ANCHOR | English description not available. | Source |
| PATENT | 2033-03-07 | FTO_TAIL | English description not available. | Source |
| PATENT | 2033-03-07 | FTO_TAIL | English description not available. | Source |
| PATENT | 2034-09-14 | FTO_TAIL | English description not available. | Source |
| PATENT | 2034-09-14 | FTO_TAIL | English description not available. | Source |
| PATENT | 2034-09-14 | FTO_TAIL | English description not available. | Source |
| PATENT | 2034-09-14 | FTO_TAIL | English description not available. | Source |
| PATENT | 2034-09-14 | FTO_TAIL | English description not available. | Source |
| PATENT | 2034-11-28 | FTO_TAIL | English description not available. | Source |
| PATENT | 2035-03-09 | FTO_TAIL | English description not available. | Source |
| PATENT | 2035-03-09 | FTO_TAIL | English description not available. | Source |
| PATENT | 2036-02-14 | FTO_TAIL | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | HISTORICAL_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | FTO_TAIL | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | FTO_TAIL | English description not available. | Source |
| REGULATORY_STATUS | 2028-11-15 | CANONICAL_DECISION | Canonical 2028-11-15; DEEP_REVIEW; latest post-anchor right 2036-02-14; Final exact ANDA link not identified; not certified generic absence. | 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.