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Opdivo Qvantig

 ·  Patent Litigation & Settlement History ↓

Ingredientnivolumab and hyaluronidase-nvhy
Application typeBLA
Application761381
Product001
Dosage formInjection
RouteSubcutaneous
Strength600MG/5ML;10,000UNITS/5ML (120MG/2,000UNITS/ML)
Approval date2024-12-27
Marketing statusPrescription
Status event—
ApplicantBRISTOL-MYERS SQUIBB
Product source

Current GenericRadar decision

Year2026
SelectionDEEP_REVIEW
ReviewFINAL_CHECKING
Anchor typeREGULATORY_EXCLUSIVITY
Anchor date2026-12-22
Patent anchor—
Exclusivity anchor2026-12-22
Protection date—
First Final ANDA—
Status event—

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Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
US125827132041-12-27— —NNU_PARTIAL_INDICATION_NON_DS_EQ
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———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
ODE2018-08-162020-12-29For 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 (Indication withdrawn)NN——Source
ODE2017-09-222021-07-23Treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (Indication withdrawn)NN——Source
ODE2014-12-222021-12-22Treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitorNN——Source
ODE2015-09-302022-09-30Treatment of patients with BRAF V600 wild-type, unresectable or metastatic melanomaNN——Source
ODE2016-05-172023-05-17Treatment of adult patients with Classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotinNN——Source
ODE2017-04-252024-04-25Treatment 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.NN——Source
ODE2017-12-202024-12-20Adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resectionNN——Source
RPE_BASELINE2014-12-222026-12-22Full-product 12-year operational assumption; not FDA determinationYY——Source
ODE2020-03-102027-03-10in combination with ipilimumab, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenibNN——Source
ODE2020-06-102027-06-10For the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.NN——Source
ODE2020-10-022027-10-02In combination with nivolumab, for the first-line treatment of adult patients with unresectable malignant pleural mesotheliomaNN——Source
ODE2020-10-022027-10-02in combination with ipilimumab, for the first-line treatment of adult patients with unresectable malignant pleural mesotheliomaNN——Source
ODE2021-04-162028-04-16in combination with fluoropyrimidine- and platinum-containing chemotherapy for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinomaNN——Source
ODE2021-04-162028-04-16in combination with fluoropyrimidine- and platinum-containing chemotherapy for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinomaNN——Source
ODE2021-05-202028-05-20adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT)NN——Source
ODE2021-05-202028-05-20adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT)NN——Source
ODE2022-05-272029-05-27in combination with ipilimumab, for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC)NN——Source
ODE2022-05-272029-05-27in 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)NN——Source
ODE2023-02-152030-02-15as a single agent or in combination with ipilimumab, for the treatment of pediatric patients 12 years and older with unresectable or metastatic melanomaNN——Source
ODE2023-02-152030-02-15adjuvant treatment of pediatric patients 12 years and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resectionNN——Source
ODE2023-10-132030-10-13adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB or Stage IIC melanomaNN——Source
ODE2025-04-112032-04-11in combination with ipilimumab, for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC)NN——Source
ODE2026-03-202033-03-20in 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)NN——Source

2026-10-10 · PENDING_EXCLUSIVITY_CONFIRMATION · Historical coverage: NOT_COMPLETE

Generic approval evidence

Application / productEventFinal dateTentative dateApplicantAuthorized genericExact mappingSource
No generic approval facts are linked to this product.

Market Entry Information

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API Master Files & Certifications 0 records

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Authorized Generics 0 records

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Application / productApplicantEvent / status First marketed Product mappingSourceLast verified
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Tentative ANDA Approvals 0 records

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Application / productApplicantEvent / status Tentative date Follow-up final approvalProduct mappingSourceLast verified
No tentative-approval records are linked to this product.

Paragraph IV Challenges 0 records

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Application / productApplicantEvent / status Certification event date Product mappingSourceLast verified
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Final ANDA Approvals 0 records

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Decision evidence (24)
TypeDateRoleBasisSource
PATENT2041-12-27OTHER_RIGHT_REFERENCEProduct scope reviewed; reference date only; current official term verification pendingSource
REGULATORY_EXCLUSIVITY2020-12-29SCOPE_HISTORYIndication-specific history; full coverage not assertedSource
REGULATORY_EXCLUSIVITY2021-07-23SCOPE_HISTORYIndication-specific history; full coverage not assertedSource
REGULATORY_EXCLUSIVITY2021-12-22SCOPE_HISTORYIndication-specific history; full coverage not assertedSource
REGULATORY_EXCLUSIVITY2022-09-30SCOPE_HISTORYIndication-specific history; full coverage not assertedSource
REGULATORY_EXCLUSIVITY2023-05-17SCOPE_HISTORYIndication-specific history; full coverage not assertedSource
REGULATORY_EXCLUSIVITY2024-04-25SCOPE_HISTORYIndication-specific history; full coverage not assertedSource
REGULATORY_EXCLUSIVITY2024-12-20SCOPE_HISTORYIndication-specific history; full coverage not assertedSource
REGULATORY_EXCLUSIVITY2026-12-22ANCHOR_CALCULATIONUser-adopted operational baseline; inherited dates do not restart RPE; not FDA determinationSource
REGULATORY_EXCLUSIVITY2027-03-10SCOPE_HISTORYIndication-specific history; full coverage not assertedSource
REGULATORY_EXCLUSIVITY2027-06-10SCOPE_HISTORYIndication-specific history; full coverage not assertedSource
REGULATORY_EXCLUSIVITY2027-10-02SCOPE_HISTORYIndication-specific history; full coverage not assertedSource
REGULATORY_EXCLUSIVITY2027-10-02SCOPE_HISTORYIndication-specific history; full coverage not assertedSource
REGULATORY_EXCLUSIVITY2028-04-16SCOPE_HISTORYIndication-specific history; full coverage not assertedSource
REGULATORY_EXCLUSIVITY2028-04-16SCOPE_HISTORYIndication-specific history; full coverage not assertedSource
REGULATORY_EXCLUSIVITY2028-05-20SCOPE_HISTORYIndication-specific history; full coverage not assertedSource
REGULATORY_EXCLUSIVITY2028-05-20SCOPE_HISTORYIndication-specific history; full coverage not assertedSource
REGULATORY_EXCLUSIVITY2029-05-27SCOPE_HISTORYIndication-specific history; full coverage not assertedSource
REGULATORY_EXCLUSIVITY2029-05-27SCOPE_HISTORYIndication-specific history; full coverage not assertedSource
REGULATORY_EXCLUSIVITY2030-02-15SCOPE_HISTORYIndication-specific history; full coverage not assertedSource
REGULATORY_EXCLUSIVITY2030-02-15SCOPE_HISTORYIndication-specific history; full coverage not assertedSource
REGULATORY_EXCLUSIVITY2030-10-13SCOPE_HISTORYIndication-specific history; full coverage not assertedSource
REGULATORY_EXCLUSIVITY2032-04-11SCOPE_HISTORYIndication-specific history; full coverage not assertedSource
REGULATORY_EXCLUSIVITY2033-03-20SCOPE_HISTORYIndication-specific history; full coverage not assertedSource
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.