Lucentis® (ranibizumab)

BL 125156

Lucentis® (ranibizumab)

BL 125156

U.S. License Holder:

Genentech

Date of License:

June-30-2006

Last Update:

April-08-2021

approved_indications FDA-Approved Indications

LUCENTIS (ranibizumab), a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with:

Neovascular (Wet) Age-Related Macular Degeneration (AMD);

Macular Edema Following Retinal Vein Occlusion (RVO);

Diabetic Macular Edema (DME);

Diabetic Retinopathy in patients with DME.

approved_indications aBLA / 505(b)(2) Activity

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

FYB201: Formycon / Bioeq (December-2019, withdrawn February-2020 with plan to resubmit) SB11 (Samsung Bioepis / Biogen) (November-2020)

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:18-cv-02434 (S.D.N.Y.)

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

Plaintiffs
Novartis Vaccines and Diagnostics, Inc.; Novartis Pharma AG; Grifols Worldwide Operations Limited

Defendants
Regeneron Pharmaceuticals, Inc.

Status
Judgment of Non-Infringement and Order of Dismissal

BPCIA
N

related articles Related News Articles

Venable Fitzpatrick’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 Fitzpatrick’s BiologicsHQ Monthly Injection – February 2020 April Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.; Ha Kung Wong March 12, 2020
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – September 2019 April Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. October 8, 2019
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – April 2019 April Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. May 7, 2019
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – March 2018 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. April 6, 2018

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.

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