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IgNextGen 16% — Competitive Intelligence Brief
phase 3
Intravenous immunoglobulin (IVIG)
Fc receptors, complement system, pathogenic antigens
Immunology
Small molecule
Live · refreshed every 30 min
Target snapshot
IgNextGen 16% (IgNextGen 16%) — CSL Limited. IgNextGen 16% is an intravenous immunoglobulin (IVIG) product that provides passive immunization by delivering pooled human antibodies to modulate immune function and replace deficient immunoglobulins.
Comparator set (6 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| IgNextGen 16% TARGET | IgNextGen 16% | CSL Limited | phase 3 | Intravenous immunoglobulin (IVIG) | Fc receptors, complement system, pathogenic antigens | |
| PRIVIGEN (CSL Behring) | PRIVIGEN (CSL Behring) | Hospices Civils de Lyon | marketed | Intravenous immunoglobulin (IVIg) | Fc receptors, complement system, pathogenic antigens and antibodies | |
| IV treatment with IGSC, 10% | IV treatment with IGSC, 10% | Baxalta now part of Shire | phase 3 | Immunoglobulin replacement therapy | Fc receptors, complement system, pathogenic antigens | |
| Ig NextGen 10% | Ig NextGen 10% | CSL Limited | phase 3 | Intravenous immunoglobulin (IVIG) | Fc receptors, complement system, pathogenic antigens | |
| IGIV3I Grifols | IGIV3I Grifols | Instituto Grifols, S.A. | phase 3 | Intravenous immunoglobulin (IVIG) | Fc receptors, complement system, pathogenic antigens | |
| Gamunex Intravenous Immunoglobulin | Gamunex Intravenous Immunoglobulin | National Institute of Mental Health (NIMH) | phase 3 | Intravenous Immunoglobulin (IVIG) | Fc receptors, complement system, pathogenic antigens | |
| IGIV GAMMAGARD LIQUID/KIOVIG | IGIV GAMMAGARD LIQUID/KIOVIG | Baxalta now part of Shire | phase 3 | Intravenous immunoglobulin (IGIV) | Fc receptors, complement system, pathogenic antigens |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
Sponsor landscape (Intravenous immunoglobulin (IVIG) class)
- CSL Limited · 4 drugs in this class
- Instituto Grifols, S.A. · 2 drugs in this class
- Bio Products Laboratory · 2 drugs in this class
- ADMA Biologics, Inc. · 2 drugs in this class
- Grifols Biologicals, LLC · 1 drug in this class
- Grifols Therapeutics LLC · 1 drug in this class
- Kedrion S.p.A. · 1 drug in this class
- Octapharma · 1 drug in this class
- Oslo University Hospital · 1 drug in this class
- SK Plasma Co., Ltd. · 1 drug in this class
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- IgNextGen 16% CI watch — RSS
- IgNextGen 16% CI watch — Atom
- IgNextGen 16% CI watch — JSON
- IgNextGen 16% alone — RSS
- Whole Intravenous immunoglobulin (IVIG) class — RSS
Cite this brief
Drug Landscape (2026). IgNextGen 16% — Competitive Intelligence Brief. https://druglandscape.com/ci/ignextgen-16. Accessed 2026-05-13.
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