CT-P41 (denosumab)

CT-P41 Approval Pending

CT-P41 (denosumab)

CT-P41 Approval Pending

U.S. License Holder:

Celltrion

Date of License:

aBLA submitted to FDA November-2023

Last Update:

June-08-2024

approved_indications FDA-Approved Indications


CT-P41 (denosumab) is not FDA-approved. An aBLA has been submitted to the FDA.

approved_indications U.S. Patent Litigations

PACER

Case No(s):

U.S. Patent Nos.
7,364,736 (Antibodies to OPGL) 7,427,659 (Process for Purifying Proteins in a Hydrophobic Interaction Chromatography Flow-through Fraction) 7,928,205 (Methods for Refolding of Recombinant Antibodies) 8,053,236 (Feed Media) 8,460,896 (Host Cells and Culture Methods) 8,680,248 (Host Cells Comprising Alpha 1, 2 Mannosidase and Culture Methods Thereof) 9,012,178 (Dipeptides to Enhance Yield and Viability from Cell Cultures) 9,228,168 (Feed Media) 9,320,816 (Methods of Treating Cell Culture Media for Use in Bioreactor) 9,328,134 (Carbohydrate Phosphonate Derivatives as Modulators of Glycosylation) 9,359,435 (Methods for Modulating Mannose Content of Recombinant Proteins) 10,106,829 (Overexpression of n-glycosylation Pathway Regulators to Modulate Glycosylation of Recombinant Proteins) 10,167,492 (Process for Manipulating the Level of Glycan Content of a Glycoprotein) 10,227,627 (Overexpression of n-glycosylation Pathway Regulators to Modulate Glycosylation of Recombinant Proteins) 10,513,723 (Decreasing Ornithine Production to Decrease High Mannose Glycoform Content of Recombinant Proteins) 10,583,397 (Process Control Systems and Methods for Use with Filters and Filtration Processes) 10,822,630 (Process for Manipulating the Level of Glycan Content of a Glycoprotein) 10,894,972 (Methods for Increasing Mannose Content of Recombinant Proteins) 11,077,404 (Process Control Systems and Methods for Use with Filters and Filtration Processes) 11,098,079 (Charged Depth Filtration of Antigen-Binding Proteins) 11,130,980 (Use of Monensin to Regulate Glycosylation of Recombinant Proteins) 11,254,963 (Increasing Ornithine Accumulation to Increase High Mannose Glycoform Content of Recombinant Proteins) 11,299,760 (Use of Monensin to Regulate Glycosylation of Recombinant Proteins) 11,319,568 (Methods for Increasing Mannose Content of Recombinant Proteins) 11,434,514 (Methods for Increasing Mannose Content of Recombinant Proteins) 11,459,595 (Methods for Increasing Mannose Content of Recombinant Proteins) 11,486,883 (Method for Using Light Scattering in Real Time to Directly Monitor and Control Impurity Removal in Purification Processes) 11,946,085 (Methods for Increasing Mannose Content of Recombinant Proteins) 11,952,605 (Methods for Increasing Mannose Content of Recombinant Proteins)

Plaintiffs
Amgen Inc.; Amgen Manufacturing Limited

Defendants
Celltrion, Inc.; Celltrion USA, Inc.

Status
Case Ongoing

BPCIA
Y

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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