Lucentis® — Venable's BiologicsHQ

U.S. License Holder:

Genentech

Date of License:

June-30-2006

Last Update:

Dec-15-2024

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 (DR);

Myopic Choroidal Neovascularization (mCNV).

aBLA / 505(b)(2) Activity

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

Byooviz: Samsung Bioepis / Biogen (September-2021; Interchangeable October-2023) Cimerli: Coherus / Bioeq (Interchangeable August-2022)

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

Xlucane: Xbrane (Withdrawn May-2022, Resubmitted April-2023, CRL April-2024)

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Byooviz (Samsung Bioepis / Biogen) (March-2022)
Ranopto® (Bioeq / Teva) (December-2023)

Biosimilars Approved In The E.U.

Byooviz (Samsung Bioepis / Biogen) (August-2021)
Ongavia (Teva / Bioeq) (May-2022 in the United Kingdom)
Ranibizumab Midas (Midas Pharma) (September-2024)
Ranivisio (Teva / Bioeq) (August-2022)
Rimmyrah® (Qilu Pharma) (January-2024)
Ximluci® (STADA / Xbrane) (November-2022 in the EU; January-2023 in the United Kingdom)

Biosimilars Approved In Australia

Byooviz (Samsung Bioepis) (August-2022)
Raniviz (Actor) (December-2023)

Biosimilars Approved In South Korea

Amelivu (Samsung Bioepis) (May-2022)
LucenBS (Chong Kun Dang) (October-2022)

Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2020-01317

U.S. Patent No.
9,220,631 (Syringe)

Patent Owner
Novartis Pharma AG; Novartis Pharmaceuticals Corporation; Novartis Technology LLC

Petitioner(s)
Regeneron Pharmaceuticals, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-26

Claim Types Challenged Under § 103
Method of Treatment Other

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted; Request for Rehearing Withdrawn

IPR2020-01318

U.S. Patent No.
9,220,631 (Syringe)

Patent Owner
Novartis Pharma AG; Novartis Pharmaceuticals Corporation; Novartis Technology LLC

Petitioner(s)
Regeneron Pharmaceuticals, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-26

Claim Types Challenged Under § 103
Method of Treatment Other

§ 103 Challenge Instituted
Terminated Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Terminated Prior to Institution Decision at Petitioner's Request)

IPR Status
Terminated Prior to Institution Decision at Petitioner's Request

IPR2020-01320

U.S. Patent No.
9,220,631 (Syringe)

Patent Owner
Novartis Pharma AG; Novartis Pharmaceuticals Corporation; Novartis Technology LLC

Petitioner(s)
Regeneron Pharmaceuticals, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-26

Claim Types Challenged Under § 103
Method of Treatment Other

§ 103 Challenge Instituted
No Decision

IPR Status
Administratively Closed, No Decision

IPR2021-00816

U.S. Patent No.
9,220,631 (Syringe)

Patent Owner
Novartis Pharma AG; Novartis Pharmaceuticals Corporation; Novartis Technology LLC

Petitioner(s)
Regeneron Pharmaceuticals, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-26

Claim Types Challenged Under § 103
Method of Treatment Other

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
23-1334

IPR Status
Final Written Decision (All Challenged Claims Unpatentable); Federal Circuit Appeal Affirmed

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
Stipulated Judgment of Non-Infringement and Order of Dismissal

BPCIA
N

1:20-cv-00690 (N.D.N.Y.)

U.S. Patent Nos.
9,220,631 (Syringe)

Plaintiffs
Novartis Pharma AG; Novartis Pharmaceuticals Corporation; Novartis Technology LLC

Defendants
Regeneron Pharmaceuticals, Inc.

Status
Stipulated Dismissal After Claims Found Unpatentable in IPR2021-00816

BPCIA
N

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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Lucentis® (ranibizumab)

Lucentis® (ranibizumab)

FDA-Approved Indications

aBLA / 505(b)(2) Activity

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

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

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Biosimilars Approved In The E.U.

Biosimilars Approved In Australia

Biosimilars Approved In South Korea

Inter Partes Review Proceedings

IPR Case No(s):

IPR2020-01317

IPR2020-01318

IPR2020-01320

IPR2021-00816

U.S. Patent Litigations

Case No(s):

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

1:20-cv-00690 (N.D.N.Y.)

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