Ruxience® (rituximab-pvvr)

aBL 761103

Ruxience® (rituximab-pvvr)

aBL 761103

U.S. License Holder:

Pfizer Inc.

Date of License:

July-23-2019

Last Update:

August-15-2019

approved_indications FDA-Approved Indications


RUXIENCE (rituximab-pvvr) is a CD20-directed cytolytic antibody indicated for the treatment of patients with:

Non-Hodgkin's Lymphoma (NHL): Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent; Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to Rituxan in combination with chemotherapy, as single-agent maintenance therapy; Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy; Previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens;

Chronic Lymphocytic Leukemia (CLL): Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC);

Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

U.S. Patent No.
7,820,161 (Treatment of Autoimmune Diseases)

Patent Owner
Biogen Inc.; Genentech, Inc.

Petitioner(s)
Pfizer Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
18-1885; 18-1924 (consolidated with 18-1885)

IPR Status
Joined with IPR2016-01614; Final Written Decision (No Instituted Claim Found Unpatentable); Federal Circuit Appeal 18-1924 Dismissed; Federal Circuit Appeal 18-1885 Voluntarily Dismissed

U.S. Patent No.
8,329,172 (Combination Therapies For B-Cell Lymphomas Comprising Administration of Anti-CD20 Antibody)

Patent Owner
Biogen Inc.

Petitioner(s)
Pfizer Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted; Petitioner's Request for Rehearing Withdrawn

U.S. Patent No.
8,557,244 (Treatment of Aggressive Non-Hodgkins Lymphoma with Anti-CD20 Antibody)

Patent Owner
Biogen Inc.

Petitioner(s)
Pfizer Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted; Petitioner's Request for Rehearing Denied

U.S. Patent No.
8,821,873 (Treatment of Diffuse Large-Cell Lymphoma With Anti-CD20 Antibody)

Patent Owner
Biogen Inc.

Petitioner(s)
Pfizer Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
19-1364

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Ongoing with USPTO Director as Intervenor, Pfizer Not Participating in Appeal

U.S. Patent No.
7,976,838 (Therapy of Autoimmune Disease in a Patient with an Inadequate Response to a TNF-alpha Inhibitor)

Patent Owner
Genentech, Inc.

Petitioner(s)
Pfizer, Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y- Settled After Institution

IPR Status
Terminated After Institution Due to Settlement

U.S. Patent No.
7,682,612 (Treatment of Hematologic Malignancies Associated with Circulating Tumor Cells Using Chimeric Anti-CD20 Antibody)

Patent Owner
Biogen Inc.; Genentech, Inc.

Petitioner(s)
Pfizer, Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

U.S. Patent No.
8,206,711 (Treatment of Chronic Lymphocytic Leukemia Using Anti-CD20 Antibodies)

Patent Owner
Biogen Inc.; Genentech, Inc.

Petitioner(s)
Pfizer, Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

U.S. Patent No.
8,545,843 (Treatment of Vasculitis)

Patent Owner
Biogen Inc.

Petitioner(s)
Pfizer, Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

U.S. Patent No.
9,296,821 (Combination Therapies for B-Cell Lymphomas Comprising Administration of Anti-CD20 Antibodies)

Patent Owner
Biogen Inc.

Petitioner(s)
Pfizer, Inc.

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y- Joint Request to Terminate

IPR Status
Terminated After Institution

U.S. Patent No.
9,504,744 (Treatment of Diffuse Large-Cell Lymphoma with Anti-CD20 Antibody)

Patent Owner
Biogen Inc.

Petitioner(s)
Pfizer, Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Terminated Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y- Petitioner Requested Dismissal with Prejudice Prior to Institution Decision

IPR Status
Terminated Prior to Institution Decision (Petitioner Requested Dismissal with Prejudice)

U.S. Patent No.
8,329,172 (Combination Therapies For B-Cell Lymphomas Comprising Administration of Anti-CD20 Antibody)

Patent Owner
Biogen Inc.

Petitioner(s)
Pfizer Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y- Settled After Institution

IPR Status
Terminated After Institution Due to Settlement

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Spotlight On: Rituxan® (rituximab) / Truxima® (rituximab-abbs) / Ruxience® (rituximab-pvvr) April Breyer Menon; Corinne E. Atton; Joyce L. Nadipuram; Robert S. Schwartz, Ph.D. July 31, 2019

Methodology

Information contained in the Venable Fitzpatrick 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 Fitzpatrick BiologicsHQ database.

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