Opdivo® (nivolumab)

BL 125554 [BL 125527]

Opdivo® (nivolumab)

BL 125554 [BL 125527]

U.S. License Holder:

Bristol-Myers Squibb

Date of License:

December-22-2014 [March-04-2015]

Last Update:

Apr-08-2024

approved_indications FDA-Approved Indications

BL 125554: OPDIVO (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of:

Melanoma: Adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab; For the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma;

Non-Small Cell Lung Cancer (NSCLC): Adult patients with resectable (tumors greater than or equal to 4 cm or node positive) non-small cell lung cancer in the neoadjuvant setting, in combination with platinum-doublet chemotherapy; Adult patients with metastatic non-small cell lung cancer expressing PD-L1 (greater than or equal to 1 percent) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with ipilimumab; Adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy; Adult patients with metastatic non-small cell lung cancer and progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Opdivo;

Malignant Pleural Mesothelioma: Adult patients with unresectable malignant pleural mesothelioma, as first-line treatment in combination with ipilimumab;

Renal Cell Carcinoma (RCC): Adult patients with intermediate or poor risk advanced renal cell carcinoma, as a first-line treatment in combination with ipilimumab; Adult patients with advanced renal cell carcinoma, as a first-line treatment in combination with cabozantinib; Adult patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy;

Classical Hodgkin Lymphoma (cHL): Adult patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or 3 or more lines of systemic therapy that includes autologous HSCT;

Squamous Cell Carcinoma of the Head and Neck (SCCHN): Adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy;

Urothelial Carcinoma: Adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC; Adult patients with unresectable or metastatic urothelial carcinoma, as firstline treatment in combination with cisplatin and gemcitabine; Adult patients with locally advanced or metastatic urothelial carcinoma who: have disease progression during or following platinum-containing chemotherapy; have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy;

Colorectal Cancer: Adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan as a single agent or in combination with ipilimumab;

Hepatocellular Carcinoma (HCC): Adult patients with hepatocellular carcinoma who have been previously treated with sorafenib in combination with ipilimumab;

Esophageal Cancer: Adult patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy (CRT); Adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy; Adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with ipilimumab; Adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine-and platinum-based chemotherapy;

Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma: Adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapy.

BL 125527: OPDIVO (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with:

Unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor;

Metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2016-01217

U.S. Patent No.
9,067,999 (Immunopotentiative Composition)

Patent Owner
Bristol-Myers Squibb Co.; ER Squibb and Sons, LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Petitioner(s)
Merck Sharp and Dohme Corp.

§ 102 Challenge
Y: Claims 1, 6-14, 19-20, 24-26, 29-30

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Settled Prior to Institution Decision

§ 103 challenge
Y: Claims 1, 6-14, 19-20, 24-27, 29-30

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Settled Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled Prior to Institution Decision)

IPR Status
Settled Prior to Institution Decision

IPR2016-01218

U.S. Patent No.
9,067,999 (Immunopotentiative Composition)

Patent Owner
Bristol-Myers Squibb Co.; ER Squibb and Sons, LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Petitioner(s)
Merck Sharp and Dohme Corp.

§ 102 Challenge
Y: Claims 1, 6-14, 19-20, 24-25

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Settled Prior to Institution Decision

§ 103 challenge
Y: Claims 1, 6-14, 19-20, 24-27, 29-30

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Settled Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled Prior to Institution Decision)

IPR Status
Settled Prior to Institution Decision

IPR2016-01219

U.S. Patent No.
9,073,994 (Immunopotentiative Composition)

Patent Owner
Bristol-Myers Squibb Co.; ER Squibb and Sons, LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Petitioner(s)
Merck and Co., Inc.; Merck Sharp and Dohme Corp.

§ 102 Challenge
Y: Claims 1-3, 8-9, 14-15, 19-22, 25

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Settled Prior to Institution Decision

§ 103 challenge
Y: Claims 1-3, 8-9, 14-15, 19-22, 25-26

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Settled Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled Prior to Institution Decision)

IPR Status
Settled Prior to Institution Decision

IPR2016-01221

U.S. Patent No.
9,073,994 (Immunopotentiative Composition)

Patent Owner
Bristol-Myers Squibb Co.; ER Squibb and Sons, LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Petitioner(s)
Merck Sharp and Dohme Corp.

§ 102 Challenge
Y: Claims 1-3, 8-9, 14-15, 19-22

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Settled Prior to Institution Decision

§ 103 challenge
Y: Claims 1-3, 8-9, 14-15, 19-22, 25-26

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Settled Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled Prior to Institution Decision)

IPR Status
Settled Prior to Institution Decision

IPR2023-00249

U.S. Patent No.
10,323,092 (Cancer Immunotherapy by Disrupting PD-1/PD-L1 Signaling)

Patent Owner
Bristol-Myers Squibb Co.

Petitioner(s)
Dana-Farber Cancer Institute, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-25

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Settled Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled Prior to Institution Decision)

IPR Status
Settled Prior to Institution Decision

IPR2023-00252

U.S. Patent No.
10,138,299 (Cancer Immunotherapy by Disrupting PD-1/PD-L1 Signaling)

Patent Owner
Bristol-Myers Squibb Co.

Petitioner(s)
Dana-Farber Cancer Institute, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-24

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Settled Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled Prior to Institution Decision)

IPR Status
Settled Prior to Institution Decision

IPR2023-00501

U.S. Patent No.
8,008,449 (Human Monoclonal Antibodies to Programmed Death 1 (PD-1) and Methods for Treating Cancer Using Anti-PD-1 Antibodies Alone or in Combination with Other Immunotherapeutics)

Patent Owner
ER Squibb & Sons, LLC; Ono Pharmaceutical Co., Ltd.

Petitioner(s)
Dana-Farber Cancer Institute, Inc.

§ 102 Challenge
Y: Claims 1, 7-8, 12-14, 21-23

Claim Types Challenged Under § 102
Composition of Matter Formulation

§ 102 Challenge Instituted
Settled Prior to Institution Decision

§ 103 challenge
Y: Claims 1, 7-9, 12-16, 21-23

Claim Types Challenged Under § 103
Composition of Matter Formulation

§ 103 Challenge Instituted
Settled Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled Prior to Institution Decision)

IPR Status
Settled Prior to Institution Decision

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:14-cv-01131 (D. Del.)

U.S. Patent Nos.
8,728,474 (Immunopotentiative Composition)

Plaintiffs
Bristol-Myers Squibb Co.; E.R. Squibb and Sons LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Defendants
Merck and Co., Inc.; Merck Sharp and Dohme Corp.

Status
Settled

BPCIA
N

1:15-cv-00560 (D. Del.)

U.S. Patent Nos.
9,067,999 (Immunopotentiative Composition)

Plaintiffs
Bristol-Myers Squibb Co.; E.R. Squibb and Sons LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Defendants
Merck and Co., Inc.; Merck Sharp and Dohme Corp.

Status
Settled

BPCIA
N

1:15-cv-00572 (D. Del.)

U.S. Patent Nos.
9,073,994 (Immunopotentiative Composition)

Plaintiffs
Bristol-Myers Squibb Co.; E.R. Squibb and Sons LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Defendants
Merck and Co., Inc.; Merck Sharp and Dohme Corp.

Status
Settled

BPCIA
N

1:17-cv-01027 (D. Del.)

U.S. Patent Nos.
9,402,899 (Immunopotentiative Composition)

Plaintiffs
Bristol-Myers Squibb Co.; E.R. Squibb and Sons LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Defendants
Genentech, Inc.

Status
Stipulated Dismissal

BPCIA
N

1:17-cv-01028 (D. Del.)

U.S. Patent Nos.
9,402,899 (Immunopotentiative Composition)

Plaintiffs
Bristol-Myers Squibb Co.; E.R. Squibb and Sons LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Defendants
AstraZeneca Pharmaceuticals LP; AstraZeneca UK Limited

Status
Stipulated Dismissal

BPCIA
N

1:17-cv-01029 (D. Del.)

U.S. Patent Nos.
9,402,899 (Immunopotentiative Composition)

Plaintiffs
Bristol-Myers Squibb Co.; E.R. Squibb and Sons LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Defendants
EMD Serono, Inc.; Merck KGaA; Pfizer Inc.

Status
Stipulated Dismissal Due to Settlement

BPCIA
N

1:22-cv-00346 (D. Del.)

U.S. Patent Nos.
9,580,505 (Human Monoclonal Antibodies to Programmed Death Ligand 1 (PD-L1) 9,580,507 (Human Monoclonal Antibodies to Programmed Death Ligand 1 (PD-L1) 10,138,299 (Cancer Immunotherapy by Disrupting PD-1 / PD-L1 Signaling) 10,266,594 (Cancer Immunotherapy by Disrupting PD-1 / PD-L1 Signaling) 10,266,595 (Cancer Immunotherapy by Disrupting PD-1 / PD-L1 Signaling) 10,266,596 (Cancer Immunotherapy by Disrupting PD-1 / PD-L1 Signaling) 10,308,714 (Cancer Immunotherapy by Disrupting PD-1 / PD-L1 Signaling) 10,323,092 (Cancer Immunotherapy by Disrupting PD-1 / PD-L1 Signaling)

Plaintiffs
Bristol-Myers Squibb Co.; E.R. Squibb and Sons, LLC

Defendants
AstraZeneca Pharmaceuticals LP; AstraZeneca UK Limited

Status
Stipulated Dismissal

BPCIA
N

1:23-cv-00459 (D. Del.)

U.S. Patent Nos.
9,402,899 (Immuopotentiative Composition)

Plaintiffs
Bristol-Myers Squibb Co.; Dana-Farber Cancer Institute, Inc.; E.R. Squibb and Sons LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Defendants
AstraZeneca Pharmaceuticals LP; AstraZeneca UK Limited

Status
Consolidated with Lead Case 1:22-cv-00346 (D. Del.); Stipulated Dismissal

BPCIA
N

Related News

Venable’s BiologicsHQ Monthly Injection – July 2023
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
August 15, 2023
Venable’s BiologicsHQ Monthly Injection – April 2023
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
May 8, 2023
Venable’s BiologicsHQ Monthly Injection – February 2023
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
March 15, 2023
Venable’s BiologicsHQ Monthly Injection – December 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
January 12, 2023
Venable’s BiologicsHQ Monthly Injection – March 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
April 18, 2022
Venable’s BiologicsHQ Monthly Injection – June 2019
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
July 9, 2019
Venable’s BiologicsHQ Monthly Injection – February 2019
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
March 6, 2019
Venable’s BiologicsHQ Monthly Injection – August/September 2017
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
October 5, 2017

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

Disclaimer

The individuals who maintain this site work for Venable LLP. The information, comments and links posted on this site do not constitute legal advice. No attorney-client relationship has been or will be formed by any communication(s) to, from or with the site and/or the author. For legal advice, contact an attorney at Venable LLP or an attorney actively practicing in your jurisdiction. Do not send any confidential or privileged information to the author; neither Venable LLP nor the author will assume any liability or responsibility for it. If you send any information, documents or materials to the site, you give permission for the author to include them on or in the site. No information, documents or materials you send to the site will be considered confidential or privileged by Venable LLP or its lawyers. Also, no such information, documents or materials will be returned to you. All decisions relating to the content belong to the author.

Subscribe for Future Updates

    captcha