Lucentis® (ranibizumab)

BL 125156

Lucentis® (ranibizumab)

BL 125156

U.S. License Holder:

Genentech

Date of License:

June-30-2006

Last Update:

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FYB201: Formycon / Bioeq (December-2019, withdrawn February-2020 with plan to resubmit) SB11 (Samsung Bioepis / Biogen) (November-2020)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

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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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