U.S. License Holder:
Date of License:
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.
aBLA / 505(b)(2) Activity
aBLA / 505(b)(2) Accepted by FDA
FYB201: Formycon / Bioeq (December-2019, withdrawn February-2020 with plan to resubmit)
U.S. Patent LitigationsPACER
U.S. Patent Nos.
5,688,688 (Vector for Expression of a Polypeptide in a Mammalian Cell)
Novartis Vaccines and Diagnostics, Inc.; Novartis Pharma AG; Grifols Worldwide Operations Limited
Regeneron Pharmaceuticals, Inc.
Judgment of Non-Infringement and Order of Dismissal