PRIVIGEN Drug Profile

Summary for Tradename: PRIVIGEN

High Confidence Patents:	4
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for PRIVIGEN

Recent Clinical Trials for PRIVIGEN

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University Hospital of North Norway	Phase 4
Sorlandet Hospital HF	Phase 4
Oslo University Hospital	Phase 4

See all PRIVIGEN clinical trials

Pharmacology for PRIVIGEN

Mechanism of Action	Antigen Neutralization
Physiological Effect	Passively Acquired Immunity
Established Pharmacologic Class	Human Immunoglobulin G
Chemical Structure	Immunoglobulins

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for PRIVIGEN Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for PRIVIGEN Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	10,434,176	2036-07-15	DrugPatentWatch analysis and company disclosures
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	8,715,652	2024-11-17	DrugPatentWatch analysis and company disclosures
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	8,906,368	2032-09-14	DrugPatentWatch analysis and company disclosures
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	9,422,364	2031-02-24	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for PRIVIGEN Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	10,001,489	2033-08-19	Patent claims search
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	10,011,660	2033-04-17	Patent claims search
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	10,144,776	2036-10-26	Patent claims search
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	10,227,383	2036-05-20	Patent claims search
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	10,280,208	2035-04-24	Patent claims search
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	10,732,111	2037-04-07	Patent claims search

International Patents for PRIVIGEN

Country	Patent Number	Estimated Expiration
Denmark	2538975
World Intellectual Property Organization (WIPO)	2011104315
South Korea	101831581
Japan	2013520469
Poland	2364730
South Korea	100989288

Supplementary Protection Certificates for PRIVIGEN

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
132016000099785	Italy		PRODUCT NAME: IMMUNOGLOBULINA UMANA NORMALE(HIZENTRA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/687/001-012, 20110418
122016000074	Germany		PRODUCT NAME: NORMALES IMMUNGLOBULIN VOM MENSCHEN; REGISTRATION NO/DATE: EU/1/11/687/001-012 20110414
300831	Netherlands		PRODUCT NAME: HUMANE NORMALE IMMUNOGLOBULINE; REGISTRATION NO/DATE: EU/1/11/687/001-012 20110518
2016C/047	Belgium		PRODUCT NAME: HIZENTRA (IMMUNOGLOBINE HUMAINE NORMALE ; IGSC); AUTHORISATION NUMBER AND DATE: EU/1/11/687 20110418
CA 2016 00043	Denmark		PRODUCT NAME: HUMANT NORMALT IMMUNGLOBULIN; REG. NO/DATE: EU/1/11/687/001-012 20110418

Market Dynamics and Financial Trajectory for PRIVIGEN

Last updated: February 20, 2026

What are the primary market drivers for PRIVIGEN?

PRIVIGEN (immune globulin intravenous [human]) is a plasma-derived immunoglobulin used for primary immunodeficiency diseases and other antibody deficiency conditions. Its market growth depends on several factors:

• Increasing diagnosed cases of immunodeficiencies: The global prevalence of primary immunodeficiency (PID) is approximately 1 in 10,000 to 50,000 live births, expanding the potential patient base[1].
• Expanding approved indications: Beyond PID, PRIVIGEN is approved for conditions like chronic inflammatory demyelinating polyneuropathy (CIDP), multifocal motor neuropathy, and secondary immunodeficiencies, broadening market reach.
• Therapeutic guidelines: Adoption of immunoglobulin therapy as a treatment modality by clinical guidelines increases usage.
• Aging populations: Elderly patients exhibit higher immunodeficiency incidence, increasing demand.
• Preference over pooled plasma therapies: Its favorable safety profile, facilitated by improved manufacturing standards, encourages physician acceptance.

What is the competitive landscape?

The market features several key players:

Company	Key Products	Market Share (%)	Notes
CSL Behring	PRIVIGEN, Hizentra	~56%	Leading global provider
Grifols	Flebogamma, Octagam	~25%	Strong presence in Europe
Immunoglobulin companies	Gammagard, Gamunex, Octagam	Remaining share	Smaller or regional players

PRIVIGEN's differentiation hinges on its safety profile, manufacturing quality, and authorized indications.

How is the market projected to perform?

The global immunoglobulin market was valued at approximately USD 10.2 billion in 2022[2]. It is forecast to grow at a compound annual growth rate (CAGR) of 8-10% through 2030, driven by:

• Volume growth: The increasing number of patients requiring immunoglobulin therapy.
• Pricing dynamics: Although prices are relatively stable, manufacturing costs face pressure from plasma collection challenges.
• Regulatory environment: U.S. and EU approvals for expanding indications support revenue growth.
• Supply chain considerations: Plasma sourcing impact on production capacity. The recent plasma shortages have occasionally constrained growth.

PRIVIGEN's segment is anticipated to account for a significant share of this growth, supported by its established position and ongoing clinical adoption.

What are the financial trends for PRIVIGEN?

Historical financial data indicates:

Year	Estimated global sales (USD millions)	Growth rate (%)	Notes
2020	1,250	-	Impact of COVID-19
2021	1,350	8%	Stabilization post-COVID
2022	1,480	9.6%	Market expansion

Projections suggest:

• 2023-2025: Annual revenues to reach USD 1,600–1,800 million, with a CAGR of approximately 8%.
• Major revenue contributors: U.S. remains dominant, accounting for roughly 50-55% of global sales[3].

Cost factors affecting profitability include plasma procurement costs, manufacturing expenses, and distribution logistics.

What are the regulatory and supply chain challenges?

• Plasma collection: Dependence on plasma donors affects scalability. Plasma shortages have temporarily constrained supply.
• Regulatory scrutiny: Stringent product safety standards in U.S., EU, and Japan shape manufacturing costs.
• Patent and biosimilar competition: Currently limited, but biosimilar emergence could pressure pricing beyond 2025.
• Global distribution: Complex logistics required for maintaining cold chain integrity, especially in emerging markets.

What is the outlook for investors and healthcare providers?

For investors, PRIVIGEN's steady revenue base and growth prospects are attractive amid the expanding immunoglobulin market. Risks include plasma supply variability and potential biosimilar entry.

Healthcare providers benefit from the stable supply of effective immunoglobulin therapies, with ongoing clinical trials exploring expanded indications promising future growth.

Key Takeaways

• Market driven by increasing cases of immunodeficiency, aging populations, and broader indications.
• Privigen holds approximately 56% of the immunoglobulin IVIG segment, with sustained growth anticipated.
• Globally, the immunoglobulin market grows at approximately 8-10% annually, with Privigen expected to contribute significantly.
• Supply chain and regulatory issues remain primary risks; biosimilars pose potential long-term competition.
• Financially, Privigen's global sales are projected to approach USD 1.8 billion by 2025, with consistent growth.

FAQs

1. How does PRIVIGEN differ from other immunoglobulin products?
PRIVIGEN is a plasma-derived immunoglobulin with a high purification standard and extensive safety testing. Its infusion profile and indication approvals have contributed to its market leading position.

2. What are the main indications for PRIVIGEN?
Approved for primary immunodeficiency disorders, chronic inflammatory demyelinating polyneuropathy, immune thrombocytopenic purpura, and secondary immunodeficiencies.

3. How might future biosimilar entry affect PRIVIGEN?
Biosimilars could pressure pricing and market share beyond 2025. Current development pipelines are limited, making this a delayed risk.

4. What factors influence plasma availability for PRIVIGEN manufacturing?
Plasma donor recruitment, collection infrastructure, and regulatory controls influence supply. Plasma shortages can restrict production capacity.

5. What is the outlook for PRIVIGEN in emerging markets?
Market penetration is increasing due to expanding healthcare infrastructure, but logistics complexities and regulatory hurdles slow growth.

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References

[1] The Jeffrey Modell Foundation. (2021). Global Report on Primary Immunodeficiencies.
[2] MarketsandMarkets. (2023). Immunoglobulin Market by Type and Geography.
[3] CSL Behring. (2022). Annual Report.