Ogivri® (trastuzumab-dkst)

aBL 761074

Ogivri® (trastuzumab-dkst)

aBL 761074

U.S. License Holder:

Mylan GmbH

Date of License:

December-01-2017

Last Update:

Sep-30-2024

approved_indications FDA-Approved Indications

OGIVRI (trastuzumab-dkst) is a HER2/neu receptor antagonist indicated for:

The treatment of HER2-overexpressing breast cancer;

The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Ogivri® (Mylan / Biocon) (May-2019)

Biosimilars Approved In The E.U.

Ogivri® (Mylan / Biocon) (December-2018)

Biosimilars Approved In Australia

Ogivri® (Mylan / Biocon) (December-2018)

Biosimilars Approved In South Korea

Ogivri® (Alvogen Korea) (August-2020)

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2016-01693

U.S. Patent No.
6,407,213 (Method for Making Humanized Antibodies)

Patent Owner
Genentech, Inc.

Petitioner(s)
Mylan Pharmaceuticals, Inc.

§ 102 Challenge
Y: Claims 1, 2, 4, 25, 29, 62-66, 71, 72, 75, 76, 78, 80, 81

Claim Types Challenged Under § 102
Composition of Matter

§ 102 Challenge Instituted
Terminated Prior to Institution Decision

§ 103 challenge
Y: Claims 1, 2, 4, 12, 25, 29-31, 33, 42, 60, 62-67, 69, 71-81

Claim Types Challenged Under § 103
Composition of Matter

§ 103 Challenge Instituted
Terminated Prior to Institution Decision

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

IPR Status
Settled Prior to Institution Decision

IPR2016-01694

U.S. Patent No.
6,407,213 (Method for Making Humanized Antibodies)

Patent Owner
Genentech, Inc.

Petitioner(s)
Mylan Pharmaceuticals, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1, 2, 4, 12, 25, 29-31, 33, 42, 60, 62-67, 69, 71-81

Claim Types Challenged Under § 103
Composition of Matter

§ 103 Challenge Instituted
Terminated Prior to Institution Decision

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

IPR Status
Settled Prior to Institution Decision

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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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