Ogivri® (trastuzumab-dkst)

aBL 761074

Ogivri® (trastuzumab-dkst)

aBL 761074

U.S. License Holder:

Mylan GmbH

Date of License:

December-01-2017

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

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

The treatment of HER2-overexpressing breast cancer;

The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

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

Related News

Spotlight On: Herceptin® (trastuzumab) / Ogivri® (trastuzumab-dkst) / Herzuma® (trastuzumab-pkrb) / Ontruzant® (trastuzumab-dttb) / Trazimera® (trastuzumab-qyyp) / Kanjinti® (trastuzumab-anns) / Hercessi™ (trastuzumab-strf)
April Breyer Menon Frederick C. Millett Corinne E. Atton Robert S. Schwartz, Ph.D.
November 30, 2024
Venable’s BiologicsHQ Monthly Injection – September 2024
Damineh Morsali, Ph.D. Monica Chou Robert S. Schwartz, Ph.D.
October 11, 2024
Venable’s BiologicsHQ Monthly Injection – July 2024
Monica Chou Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
August 10, 2024
Venable’s BiologicsHQ Monthly Injection – June 2024
Monica Chou Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
July 9, 2024
Venable’s BiologicsHQ Monthly Injection – May 2024
Damineh Morsali, Ph.D. Monica Chou Robert S. Schwartz, Ph.D.
June 11, 2024
Venable’s BiologicsHQ Monthly Injection – April 2024
Monica Chou Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
May 16, 2024
Venable’s BiologicsHQ Monthly Injection – March 2024
Monica Chou Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
April 10, 2024
Venable’s BiologicsHQ Monthly Injection – February 2024
Damineh Morsali, Ph.D. Monica Chou Robert S. Schwartz, Ph.D.
March 13, 2024
Venable’s BiologicsHQ Monthly Injection – January 2024
Monica Chou Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
February 13, 2024
Venable’s BiologicsHQ Monthly Injection – December 2023
Damineh Morsali, Ph.D. Monica Chou Robert S. Schwartz, Ph.D.
January 13, 2024
Venable’s BiologicsHQ Monthly Injection – September 2023
Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
October 16, 2023
Venable’s BiologicsHQ Monthly Injection – August 2023
Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
September 12, 2023
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 – June 2023
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
July 15, 2023
Venable’s BiologicsHQ Monthly Injection – May 2023
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
June 13, 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 – March 2023
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
April 10, 2023
The State of Biosimilars in 2023
April Breyer Menon Ha Kung Wong
March 17, 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 – January 2023
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
February 9, 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 – November 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
December 14, 2022
Venable’s BiologicsHQ Monthly Injection – October 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
November 14, 2022
Venable’s BiologicsHQ Monthly Injection – September 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
October 11, 2022
Venable’s BiologicsHQ Monthly Injection – August 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
September 8, 2022
Venable’s BiologicsHQ Monthly Injection – July 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
August 5, 2022
Venable’s BiologicsHQ Monthly Injection – June 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
July 8, 2022
Venable’s BiologicsHQ Monthly Injection – May 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
June 7, 2022
Venable’s BiologicsHQ Monthly Injection – April 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
May 9, 2022
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 – February 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
March 8, 2022
Venable’s BiologicsHQ Monthly Injection – October 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
November 10, 2021
Venable’s BiologicsHQ Monthly Injection – September 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
October 12, 2021
Venable’s BiologicsHQ Monthly Injection – August 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
September 8, 2021
Venable’s BiologicsHQ Monthly Injection – July 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
August 11, 2021
Venable’s BiologicsHQ Monthly Injection – June 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
July 13, 2021
Venable’s BiologicsHQ Monthly Injection – May 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
June 17, 2021
Venable’s BiologicsHQ Monthly Injection – April 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
May 12, 2021
Venable’s BiologicsHQ Monthly Injection – March 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
April 7, 2021
Venable’s BiologicsHQ Monthly Injection – February 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
March 9, 2021
Venable’s BiologicsHQ Monthly Injection – January 2021
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
February 8, 2021
Venable’s BiologicsHQ Monthly Injection – December 2020
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
January 12, 2021
Venable’s BiologicsHQ Monthly Injection – November 2020
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
December 9, 2020
Venable’s BiologicsHQ Monthly Injection – October 2020
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
November 9, 2020
Venable’s BiologicsHQ Monthly Injection – September 2020
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
October 8, 2020
Venable’s BiologicsHQ Monthly Injection – August 2020
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
September 9, 2020
Venable’s BiologicsHQ Monthly Injection – July 2020
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
August 10, 2020
Venable’s BiologicsHQ Monthly Injection – June 2020
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
July 9, 2020
Venable’s BiologicsHQ Monthly Injection – May 2020
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
June 8, 2020
Venable’s BiologicsHQ Monthly Injection – April 2020
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D. Ha Kung Wong
May 6, 2020
Venable’s BiologicsHQ Monthly Injection – March 2020
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D. Ha Kung Wong
April 8, 2020
Venable’s BiologicsHQ Monthly Injection – February 2020
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D. Ha Kung Wong
March 12, 2020
Venable’s BiologicsHQ Monthly Injection – January 2020
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D. Ha Kung Wong
February 6, 2020
Venable’s BiologicsHQ Monthly Injection – December 2019
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D. Ha Kung Wong
January 7, 2020
Venable’s BiologicsHQ Monthly Injection – May 2019
April Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
June 6, 2019
Venable’s BiologicsHQ Monthly Injection – December 2018
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
January 9, 2019
Venable’s BiologicsHQ Monthly Injection – December 2017
April M. Breyer Menon Corinne E. Atton Robert S. Schwartz, Ph.D.
January 8, 2018

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