GP2411 (denosumab)

GP2411 Approval Pending

GP2411 (denosumab)

GP2411 Approval Pending

U.S. License Holder:

Sandoz

Date of License:

aBLA accepted by FDA February-2023

Last Update:

Sep-15-2023

approved_indications FDA-Approved Indications

GP2411 (denosumab) is not FDA-approved. An aBLA has been accepted by the FDA.

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:23-cv-02406 (D.N.J.)

U.S. Patent Nos.
7,364,736 (Antibodies to OPGL) 7,928,205 (Methods for Refolding of Recombinant Antibodies) 8,058,418 (Polynucleotides Encoding Heavy and Light Chains of Antibodies to OPGL) 9,012,178 (Dipeptides to Enhance Yield and Viability from Cell Cultures) 9,133,493 (Method for Culturing Mammalian Cells to Improve Recombinant Protein Production) 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) 9,481,901 (Methods for Increasing Mannose Content of Recombinant Proteins) 10,167,492 (Process for Manipulating the Level of Glycan Content of a Glycoprotein) 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) 11,434,514 (Methods for Increasing Mannose Content of Recombinant Proteins)

Plaintiffs
Amgen Inc.; Amgen Manufacturing Limited

Defendants
Sandoz Inc.; Sandoz GmbH; Novartis AG; Novartis Pharmaceuticals Production D.o.o.; Lek Pharmaeuticals dd

Status
Case Ongoing

BPCIA
Y

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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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