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Flebogamma 5% DIF — Competitive Intelligence Brief

Flebogamma 5% DIF (Flebogamma 5% DIF) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Intravenous immunoglobulin (IVIG). Area: Immunology.

marketed Intravenous immunoglobulin (IVIG) Fc receptors, pathogenic antigens and antibodies Immunology Biologic Live · refreshed every 30 min

Target snapshot

Flebogamma 5% DIF (Flebogamma 5% DIF) — Instituto Grifols, S.A.. Flebogamma 5% DIF is an intravenous immunoglobulin (IVIG) preparation that provides passive immunity by supplying pooled human antibodies to modulate immune responses and replace deficient immunoglobulins.

Comparator set (6 drugs)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Flebogamma 5% DIF TARGET Flebogamma 5% DIF Instituto Grifols, S.A. marketed Intravenous immunoglobulin (IVIG) Fc receptors, pathogenic antigens and antibodies
PRIVIGEN (CSL Behring) PRIVIGEN (CSL Behring) Hospices Civils de Lyon marketed Intravenous immunoglobulin (IVIg) Fc receptors, complement system, pathogenic antigens and antibodies
Asceniv™ Asceniv™ ADMA Biologics, Inc. marketed Intravenous immunoglobulin (IVIG) Polyclonal immunoglobulins (IgG)
IgPro IgPro CSL Behring marketed Intravenous immunoglobulin (IVIG) Multiple pathogenic antigens (polyvalent)
Gammaplex (5%) Gammaplex (5%) Bio Products Laboratory marketed Intravenous immunoglobulin (IVIG) Fc receptors and complement system (indirect mechanism via antibody delivery)
IgNextGen 16% IgNextGen 16% CSL Limited phase 3 Intravenous immunoglobulin (IVIG) Fc receptors, complement system, pathogenic antigens
RI-002 RI-002 ADMA Biologics, Inc. phase 3 Intravenous immunoglobulin (IVIG)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Intravenous immunoglobulin (IVIG) class)

  1. CSL Limited · 4 drugs in this class
  2. Instituto Grifols, S.A. · 2 drugs in this class
  3. Bio Products Laboratory · 2 drugs in this class
  4. ADMA Biologics, Inc. · 2 drugs in this class
  5. Grifols Biologicals, LLC · 1 drug in this class
  6. Grifols Therapeutics LLC · 1 drug in this class
  7. Kedrion S.p.A. · 1 drug in this class
  8. Octapharma · 1 drug in this class
  9. Oslo University Hospital · 1 drug in this class
  10. SK Plasma Co., Ltd. · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Flebogamma 5% DIF — Competitive Intelligence Brief. https://druglandscape.com/ci/flebogamma-5-dif. Accessed 2026-05-16.

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