Tysabri® — Venable's BiologicsHQ

U.S. License Holder:

Biogen Idec

Date of License:

November-23-2004

Last Update:

Dec-15-2024

FDA-Approved Indications

TYSABRI (natalizumab) is an integrin receptor antagonist indicated for the treatment of:

Multiple Sclerosis (MS): as monotherapy for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults;

Crohn's Disease (CD): for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn's disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-alpha.

aBLA / 505(b)(2) Activity

aBLA / 505(b)(2) Approved by FDA

Tyruko®: Sandoz / Polpharma (August-2023)

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In The E.U.

Tyruko® (Sandoz / Polpharma) (September-2023)

Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2016-00912

U.S. Patent No.
8,815,236 (Method for Treating Multiple Sclerosis and Crohn's Disease)

Patent Owner
Biogen MA, Inc.

Petitioner(s)
Swiss Pharma International AG

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-16, 21, 22

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted; Request for Rehearing Denied

IPR2016-00915

U.S. Patent No.
8,349,321 (Immunoglobulin Formulation and Method of Preparation Thereof)

Patent Owner
Biogen MA, Inc.; Elan Pharmaceuticals, Inc.

Petitioner(s)
Swiss Pharma International AG

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-4

Claim Types Challenged Under § 103
Formulation Other (Article of Manufacture)

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted; Request for Rehearing Denied

IPR2016-00916

U.S. Patent No.
8,900,577 (Immunoglobulin Formulations and Method of Preparation Thereof)

Patent Owner
Biogen MA, Inc.

Petitioner(s)
Swiss Pharma International AG

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1, 3-7, 9-12

Claim Types Challenged Under § 103
Formulation Other (Article of Manufacture)

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted; Request for Rehearing Denied

PGR2022-00054

U.S. Patent No.
11,292,845 (Methods of Treating Inflammatory and Autoimmune Diseases with Natalizumab)

Patent Owner
Biogen MA, Inc.

Petitioner(s)
Sandoz, Inc.; Polpharma SA

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-16

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
Challenges Also Include Ineligible Subject Matter (Claims 1-16) and Written Description (Claims 1-16). PGR Not Instituted

U.S. Patent Litigations

PACER

Case No(s):

1:11-cv-00084 (D. Del.)

U.S. Patent Nos.
5,688,688 (Vector for Expression of a Polypeptide in a Mammalian Cell)

Plaintiffs
Novartis Pharma AG; Novartis Vaccines and Diagnostics Inc.

Defendants
Alexion Pharmaceuticals, Inc.; Biogen IDEC, Inc.; MedImmune LLC

Status
Dismissed

BPCIA
N

1:22-cv-01190 (D. Del.)

U.S. Patent Nos.
7,157,276 (Use of Depth Filtration in Series with Continuous Centrifugation to Clarify Mammalian Cell Cultures) 7,759,117 (Use of Depth Filtration in Series with Continuous Centrifugation to Clarify Mammalian Cell Cultures) 8,124,350 (Methods and Products for Evaluating an Immune Response to a Therapeutic Protein) 8,318,416 (Nutrient Monitoring and Feedback Control for Increased Bioproduct Production) 8,809,049 (Methods for Producing Mammalian Cells) 8,871,449 (Methods and Products for Evaluating an Immune Response to a Therapeutic Protein) 9,005,926 (Methods of Preventing and Removing Trisulfide Bonds) 9,096,879 (Method of Supplementing Culture Media to Prevent Undesirable Amino Acid Substitutions) 9,109,015 (Method of Isolating Biomacromolecules Using Low pH and Divalent Cations) 9,212,379 (Nutrient Monitoring and Feedback Control for Increased Bioproduct Production) 9,316,641 (Assay for JC Virus Antibodies) 9,493,567 (Methods of Treating Inflammatory and Autoimmune Diseases with Natalizumab) 9,562,252 (Methods of Preventing and Removing Trisulfide Bonds) 9,696,307 (Methods for the Detection of JC Polyoma Virus) 9,709,575 (Methods and Products for Evaluating an Immune Response to a Therapeutic Protein) 9,790,533 (Methods of Preventing and Removing Trisulfide Bonds) 10,119,976 (Method of Assessing Risk of PML) 10,233,245 (Methods of Treating Inflammatory and Autoimmune Diseases with Natalizumab) 10,308,706 (Methods of Preventing and Removing Trisulfide Bonds) 10,444,234 (Assay for JC Virus Antibodies) 10,590,454 (Methods of Preventing and Removing Trisulfide Bonds) 10,677,803 (Method of Assessing Risk of PML) 10,705,095 (Methods and Products for Evaluating an Immune Response to a Therapeutic Protein) 10,844,416 (Manganese Supplementation for Control of Glycosylation in Mammalian Cell Culture Process) 11,268,119 (Copper Supplementation for Control of Glycosylation in Mammalian Cell Culture Process) 11,280,794 (Method of Assessing Risk of PML) 11,287,423 (Assay for JC Virus Antibodies) 11,292,845 (Methods of Treating Inflammatory and Autoimmune Diseases with Natalizumab)

Plaintiffs
Biogen, Inc.; Biogen MA Inc.

Defendants
Sandoz Inc.; Polpharma Biologics SA

Status
Stipulated Dismissal of U.S. Patent Nos. 9,109,015 and 9,096,879; Case Ongoing, Preliminary Injunction Denied

BPCIA
Y

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.

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Tysabri® (natalizumab)

Tysabri® (natalizumab)

FDA-Approved Indications

aBLA / 505(b)(2) Activity

aBLA / 505(b)(2) Approved by FDA

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In The E.U.

Inter Partes Review Proceedings

IPR Case No(s):

IPR2016-00912

IPR2016-00915

IPR2016-00916

PGR2022-00054

U.S. Patent Litigations

Case No(s):

1:11-cv-00084 (D. Del.)

1:22-cv-01190 (D. Del.)

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