Opdivo Qvantig
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
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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."}],"tail_patents":["US12582713"]}
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| US12582713 | 2041-12-27 | — — | N | N | U_PARTIAL_INDICATION_NON_DS_EQ {"classification":"U_PARTIAL_INDICATION_NON_DS_EQ","claim_count":30,"claim_number_coverage_complete":true,"reference_date_only":true,"official_current_term_verified":false,"commercial_product_mapping":"NOT_ESTABLISHED","batch":"BLA-05-06"} | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| ODE | 2018-08-16 | 2020-12-29 | For the treatment of patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy. (Indication withdrawn) | N | N | — | — | Source |
| ODE | 2017-09-22 | 2021-07-23 | Treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (Indication withdrawn) | N | N | — | — | Source |
| ODE | 2014-12-22 | 2021-12-22 | Treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor | N | N | — | — | Source |
| ODE | 2015-09-30 | 2022-09-30 | Treatment of patients with BRAF V600 wild-type, unresectable or metastatic melanoma | N | N | — | — | Source |
| ODE | 2016-05-17 | 2023-05-17 | Treatment of adult patients with Classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin | N | N | — | — | Source |
| ODE | 2017-04-25 | 2024-04-25 | Treatment of adult patients with Classical Hodgkin lymphoma that has relapsed or progressed after 3 or more lines of systemic therapy that includes autologous HSCT, not including any overlap with the orphan exclusivity awarded for the 2016 marketing approval of nivolumab for the treatment of adult patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin. | N | N | — | — | Source |
| ODE | 2017-12-20 | 2024-12-20 | Adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection | N | N | — | — | Source |
| RPE_BASELINE | 2014-12-22 | 2026-12-22 | Full-product 12-year operational assumption; not FDA determination | Y | Y | — | — | Source |
| ODE | 2020-03-10 | 2027-03-10 | in combination with ipilimumab, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib | N | N | — | — | Source |
| ODE | 2020-06-10 | 2027-06-10 | For the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. | N | N | — | — | Source |
| ODE | 2020-10-02 | 2027-10-02 | In combination with nivolumab, for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma | N | N | — | — | Source |
| ODE | 2020-10-02 | 2027-10-02 | in combination with ipilimumab, for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma | N | N | — | — | Source |
| ODE | 2021-04-16 | 2028-04-16 | in combination with fluoropyrimidine- and platinum-containing chemotherapy for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma | N | N | — | — | Source |
| ODE | 2021-04-16 | 2028-04-16 | in combination with fluoropyrimidine- and platinum-containing chemotherapy for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma | N | N | — | — | Source |
| ODE | 2021-05-20 | 2028-05-20 | adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT) | N | N | — | — | Source |
| ODE | 2021-05-20 | 2028-05-20 | adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT) | N | N | — | — | Source |
| ODE | 2022-05-27 | 2029-05-27 | in combination with ipilimumab, for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) | N | N | — | — | Source |
| ODE | 2022-05-27 | 2029-05-27 | in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) | N | N | — | — | Source |
| ODE | 2023-02-15 | 2030-02-15 | as a single agent or in combination with ipilimumab, for the treatment of pediatric patients 12 years and older with unresectable or metastatic melanoma | N | N | — | — | Source |
| ODE | 2023-02-15 | 2030-02-15 | adjuvant treatment of pediatric patients 12 years and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection | N | N | — | — | Source |
| ODE | 2023-10-13 | 2030-10-13 | adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB or Stage IIC melanoma | N | N | — | — | Source |
| ODE | 2025-04-11 | 2032-04-11 | in combination with ipilimumab, for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) | N | N | — | — | Source |
| ODE | 2026-03-20 | 2033-03-20 | in combination with doxorubicin, vinblastine, and dacarbazine (AVD), for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL) | N | N | — | — | Source |
2026-10-10 · PENDING_EXCLUSIVITY_CONFIRMATION · 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 (24)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2041-12-27 | OTHER_RIGHT_REFERENCE | Product scope reviewed; reference date only; current official term verification pending | Source |
| REGULATORY_EXCLUSIVITY | 2020-12-29 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2021-07-23 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2021-12-22 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2022-09-30 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2023-05-17 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2024-04-25 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2024-12-20 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2026-12-22 | ANCHOR_CALCULATION | User-adopted operational baseline; inherited dates do not restart RPE; not FDA determination | Source |
| REGULATORY_EXCLUSIVITY | 2027-03-10 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2027-06-10 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2027-10-02 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2027-10-02 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2028-04-16 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2028-04-16 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2028-05-20 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2028-05-20 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2029-05-27 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2029-05-27 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2030-02-15 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2030-02-15 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2030-10-13 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2032-04-11 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | Source |
| REGULATORY_EXCLUSIVITY | 2033-03-20 | SCOPE_HISTORY | Indication-specific history; full coverage not asserted | 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.
