Rixathon® (rituximab)

Rixathon® Approval Pending

Rixathon® (rituximab)

Rixathon® Approval Pending

U.S. License Holder:

Sandoz

Date of License:

aBLA accepted by FDA September-2017; Complete Response Letter May-2018

Last Update:

December-09-2018

approved_indications FDA-Approved Indications


RIXATHON (rituximab) is not FDA-approved. An aBLA has been accepted by the FDA.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In The E.U.

Rixathon® (Sandoz) (June-2017)
Riximyo (Sandoz) (June-2017)

Biosimilars Approved In Australia

Riximyo® (Sandoz) (November-2017)

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

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)
Sandoz, 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.
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)
Sandoz, Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

approved_indications U.S. Patent Litigations

PACER

Case No(s):

U.S. Patent Nos.
6,121,428 (Protein Recovery) 6,331,415 (Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein) 6,489,447 (Protein Purification) 6,610,516 (Cell Culture Process) 6,620,918 (Separation of Polypeptide Monomers) 6,870,034 (Protein Purification) 7,381,560 (Expression and Use of Anti-CD20 Antibodies) 7,485,704 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,807,799 (Reducing Protein A Leaching During Protein A Affinity Chromatography) 7,820,161 (Treatment of Autoimmune Diseases) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen) 7,976,838 (Therapy of Autoimmune Disease in a Patient with an Inadequate Response to a TNF-alpha Inhibitor) 8,206,711 (Treatment of Chronic Lymphocytic Leukemia Using Anti-CD20 Antibodies) 8,314,225 (Heavy Chain Mutant Leading to Improved Immunoglobulin Production) 8,329,172 (Combination Therapies For B-Cell Lymphomas Comprising Administration of Anti-CD20 Antibody) 8,512,983 (Production of Proteins in Glutamine-Free Cell Culture Media) 8,545,843 (Treatment of Vasculitis) 8,557,244 (Treatment of Aggressive Non-Hodgkins Lymphoma with Anti-CD20 Antibody) 8,574,869 (Prevention of Disulfide Bond Reduction During Recombinant Production of Polypeptides) 8,710,196 (Protein Purification) 8,821,873 (Treatment of Diffuse Large-Cell Lymphoma With Anti-CD20 Antibody) 9,296,821 (Combination Therapies for B-Cell Lymphomas Comprising Administration of Anti-CD20 Antibodies) 9,504,744 (Treatment of Diffuse Large-Cell Lymphoma with Anti-CD20 Antibody) 9,714,293 (Production of Proteins in Glutamine-free Cell Culture Media)

Plaintiffs
Biogen, Inc.; City of Hope; Genentech, Inc.

Defendants
Sandoz GmbH; Sandoz Inc.; Sandoz International GmbH

Status
Joint Stiuplation of Dismissal Submitted

BPCIA
Y

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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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