Tevimbra
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
{"sequence":277,"product_key":"US:BLA:761232:001","judgment_status":"PROVISIONAL_EVIDENCE_SCREEN","review_basis":"INCOMPLETE_EVIDENCE_ONLY","reason_codes":["PATENT_TERM_NOT_LOCATED: US8735553"],"unknown_patent_terms":["US8735553"],"pending_publications":[],"regulatory_anchor":"2036-03-13","later_regulatory_events":[],"batch":"BLA-05-06","review_version":"1.1","selection_status":"DEEP_REVIEW","verified":false,"anchor_status":"OPERATIONAL_UNVERIFIED","rights_anchor_date":"2036-03-13","patent_anchor_numbers":["US8735553"],"patent_term_verified":false,"canonical_judgment_confirmed":false,"first_biosimilar_approval_date":null,"first_final_generic_date":null,"has_existing_generic":null,"has_existing_biosimilar":null,"report":"BLA_05_06_50_JUDGMENT_20261021.html","report_sha256":"d3f5cba95e750a9f93f53184cc6d1c82c363bb5bb718ddbc60ccfe5c14efed29","regulatory_update_pending":true,"local_patent_review_pending":true,"FDA_followup":[{"issue":"FDA_RPE_DETERMINATION_AND_END_DATE_NOT_LOCATED","status":"UPDATE_PENDING","reason":"FDA PB target fields remain blank; no additional exact-target final determination located in the retrieved public FDA letters/review/administrative documents. Orange Book has no target BLA rows. Operational baseline retained with verified=false."},{"issue":"FDA_ODE_END_DATE_OR_PROTECTED_SCOPE_NOT_PUBLISHED","status":"UPDATE_PENDING","events":[{"source":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=708919","approval_date":"2026-08-25","date_display":"Not Detected","end_date_raw":"TBD"},{"source":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=738120","approval_date":"2026-08-25","date_display":"Not Detected","end_date_raw":"TBD"}],"reason":"Refreshed official individual OOPD pages continue to show TBD/no protected scope; no exact award date located in retrieved FDA documents. Search endpoint returned 503."}],"tail_patents":[]}
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US8735553 | — | — — | Y | N | TRUE_DS {"classification":"TRUE_DS","claim_count":35,"claim_number_coverage_complete":true,"reference_date_only":true,"official_current_term_verified":false,"commercial_product_mapping":"SUPPORTED_BY_PRIMARY_SEQUENCE_OR_STRUCTURE","batch":"BLA-05-06"} | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| ODE | 2026-08-25 | — | N | N | — | — | Source | |
| ODE | 2026-08-25 | — | N | N | — | — | Source | |
| ODE | 2024-03-13 | 2031-03-13 | treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor | N | N | — | — | Source |
| ODE | 2024-12-26 | 2031-12-26 | first-line treatment of adults with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) whose tumors express PD-L1 (greater than or equal to 1) | N | N | — | — | Source |
| ODE | 2025-03-03 | 2032-03-03 | first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (greater than or equal to 1) | N | N | — | — | Source |
| Orphan Exclusivity Exp. Date | — | 2032-03-03 | — | — | — | — | Source | |
| RPE_BASELINE | 2024-03-13 | 2036-03-13 | Full-product 12-year operational assumption; not FDA determination | Y | Y | — | — | 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 (7)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | — | ANCHOR_REFERENCE | Product scope reviewed; reference date only; current official term verification pending | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2031-03-13 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2031-12-26 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2032-03-03 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2036-03-13 | ANCHOR_CALCULATION | User-adopted operational baseline; inherited dates do not restart RPE; not FDA determination | 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.