BORTEZOMIB
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
FDA_DISCONTINUED_EVENT_YEAR
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US5780454 | 2017-11-03 | HISTORICAL_REFERENCE_SCOPE_REVIEWED — | Y | N | TRUE_DS English description not available. | — | 2017-11-03 | — |
| US6713446 | 2022-07-25 | HISTORICAL_REFERENCE_SCOPE_REVIEWED — | N | N | OTHER English description not available. | — | 2022-07-25 | — |
| US6958319 | 2022-07-25 | HISTORICAL_REFERENCE_SCOPE_REVIEWED — | N | N | OTHER English description not available. | — | 2022-07-25 | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2003-05-13 | 2008-05-13 | English description not available. | Y | Y | 2008-05-13 | — | Source |
| ODE | 2003-05-13 | 2010-05-13 | MM ≥2 prior therapies | N | N | 2021-10-08 | Source | |
| ODE | 2005-03-25 | 2012-03-25 | MM ≥1 prior therapy | N | N | 2021-10-08 | Source | |
| ODE | 2006-12-08 | 2013-12-08 | MCL ≥1 prior therapy | N | N | 2021-10-08 | Source | |
| ODE | 2008-06-20 | 2015-06-20 | MM first-line | N | N | 2021-10-08 | Source | |
| ODE | 2014-10-08 | 2021-10-08 | MCL first-line | N | N | 2021-10-08 | Source |
2026-10-13 · HISTORICAL_RECORDS_RECOVERED · Historical coverage: ANNUALS_AND_MONTHLY_REVIEWED
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 |
|---|---|---|---|---|---|---|---|
| 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 (10)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2017-11-03 | CANONICAL_ANCHOR | English description not available. | Source |
| PATENT | 2022-07-25 | FTO_TAIL | English description not available. | Source |
| PATENT | 2022-07-25 | FTO_TAIL | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | 2008-05-13 | SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | 2021-10-08 | SCOPE_CONTEXT | MM ≥2 prior therapies | Source |
| REGULATORY_EXCLUSIVITY | 2021-10-08 | SCOPE_CONTEXT | MM ≥1 prior therapy | Source |
| REGULATORY_EXCLUSIVITY | 2021-10-08 | SCOPE_CONTEXT | MCL ≥1 prior therapy | Source |
| REGULATORY_EXCLUSIVITY | 2021-10-08 | SCOPE_CONTEXT | MM first-line | Source |
| REGULATORY_EXCLUSIVITY | 2021-10-08 | SCOPE_CONTEXT | MCL first-line | Source |
| REGULATORY_STATUS | — | TERMINAL_STATUS | FDA_DISCONTINUED_EVENT_YEAR | 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.