IVIG-PEG — Competitive Intelligence Brief

IVIG-PEG (IVIG-PEG) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Immunoglobulin replacement therapy. Area: Immunology.

phase 3 Immunoglobulin replacement therapy Fc receptors and complement system (via pooled human IgG) Immunology Biologic

Target snapshot

IVIG-PEG (IVIG-PEG) — Grifols Therapeutics LLC. IVIG-PEG is a polyethylene glycol-conjugated intravenous immunoglobulin that provides passive immune protection by delivering pooled human antibodies with extended half-life.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
IVIG-PEG TARGET	IVIG-PEG	Grifols Therapeutics LLC	phase 3	Immunoglobulin replacement therapy	Fc receptors and complement system (via pooled human IgG)
HyQvia	HyQvia	Takeda	marketed	Immunoglobulin replacement therapy; enzyme-facilitated subcutaneous immunoglobulin	Hyaluronic acid in subcutaneous tissue; immunoglobulin G replacement
IgM rich Immunoglobin	IgM rich Immunoglobin	Sir Takhtasinhji General Hospital	marketed	Immunoglobulin replacement therapy	IgM antibodies; complement system (C1q)
Immune Globulin (Human)	Immune Globulin (Human)	Grifols Therapeutics LLC	marketed	Immunoglobulin replacement therapy	Multiple pathogenic antigens and pathogens (non-specific)
Cuvitru 20 % Injectable Solution	Cuvitru 20 % Injectable Solution	University of Edinburgh	marketed	Immunoglobulin replacement therapy	Fc receptors and complement system (via IgG antibodies)
Intravenous immune globulin G	Intravenous immune globulin G	Rutgers, The State University of New Jersey	marketed	Immunoglobulin replacement therapy / Immunomodulator	Multiple (polyclonal IgG antibodies targeting various pathogens and self-antigens)
IgPro20	IgPro20	CSL Behring	marketed	Immunoglobulin replacement therapy	Polyclonal IgG (multiple epitopes)

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 (Immunoglobulin replacement therapy class)

1. CSL Behring · 3 drugs in this class
2. Grifols Therapeutics LLC · 2 drugs in this class
3. Baxalta now part of Shire · 1 drug in this class
4. Biopharma Plasma LLC · 1 drug in this class
5. Sir Takhtasinhji General Hospital · 1 drug in this class
6. University of Edinburgh · 1 drug in this class