Hepatitis b immune globulin (human) - Biologic Drug Details

Summary for hepatitis b immune globulin (human)

Tradenames:	3
High Confidence Patents:	0
Applicants:	3
BLAs:	3
Suppliers: see list	3
Recent Clinical Trials:	See clinical trials for hepatitis b immune globulin (human)

Recent Clinical Trials for hepatitis b immune globulin (human)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Aarhus University Hospital	PHASE1
Charite University, Berlin, Germany	PHASE1
University of Pennsylvania	Phase 2

See all hepatitis b immune globulin (human) clinical trials

Pharmacology for hepatitis b immune globulin (human)

Mechanism of Action	Virus Neutralization
Physiological Effect	Passively Acquired Immunity
Established Pharmacologic Class	Human Immunoglobulin
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 brand-side disclosures

These patents were identified from searching 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 hepatitis b immune globulin (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for hepatitis b immune globulin (human) 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
Adma Biologics, Inc.	NABI-HB	hepatitis b immune globulin (human)	Injection	103945	9,107,906	2035-01-08	DrugPatentWatch analysis and company disclosures
Adma Biologics, Inc.	NABI-HB	hepatitis b immune globulin (human)	Injection	103945	9,512,201	2033-09-24	DrugPatentWatch analysis and company disclosures
Adma Biologics, Inc.	NABI-HB	hepatitis b immune globulin (human)	Injection	103945	9,815,886	2035-01-08	DrugPatentWatch analysis and company disclosures
Kamada Ltd.	HEPAGAM B	hepatitis b immune globulin (human)	Injection	125035	6,890,534	2018-02-05	DrugPatentWatch analysis and company disclosures
Kamada Ltd.	HEPAGAM B	hepatitis b immune globulin (human)	Injection	125035	7,553,490	2024-11-12	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for hepatitis b immune globulin (human) 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
Adma Biologics, Inc.	NABI-HB	hepatitis b immune globulin (human)	Injection	103945	11,072,615	2039-11-08	Patent claims search
Kamada Ltd.	HEPAGAM B	hepatitis b immune globulin (human)	Injection	125035	11,072,615	2039-11-08	Patent claims search

International Patents for hepatitis b immune globulin (human)

Country	Patent Number	Estimated Expiration
Israel	263819
China	104662041
European Patent Office	2900692
World Intellectual Property Organization (WIPO)	2014048910
Japan	2016504015
South Africa	201707303

Hepatitis b immune globulin (human) Market Analysis and Financial Projection

Last updated: April 25, 2026

Hepatitis B Immune Globulin (Human): Market Dynamics and Financial Trajectory

What is the current market structure for Hepatitis B immune globulin (human)?

Hepatitis B immune globulin (human) (HBIG) sits in a narrow, indication-driven segment with demand anchored to prevention and post-exposure prophylaxis rather than chronic disease management. The product category is defined by (1) availability of passive protection in settings that require immediate anti-HBs coverage and (2) use-case risk tolerance in the healthcare and blood-safety ecosystem. The market dynamics therefore track procedure volumes, transmission-risk mitigation policies, and the degree of hepatitis B vaccination and antiviral coverage in target populations.

HBIG products are used for:

• Post-exposure prophylaxis (e.g., needlestick and sexual exposure where the source is hepatitis B surface antigen positive or unknown and the exposed person has inadequate immunity).
• Perinatal prevention (infant prophylaxis at birth in defined scenarios).
• Immunoprophylaxis in specific clinical pathways (e.g., liver transplant and high-risk categories depending on regional protocols).

This is not a broad-based therapeutics market. It is a policy and protocol market with switching costs driven by clinical guidance, product access, and supply chain reliability.

How do demand drivers shape pricing power and volume?

Demand is relatively inelastic for HBIG within governed clinical protocols, with volume moving in line with:

• Exposure events that trigger prophylaxis.
• Perinatal high-risk scenarios where prophylaxis is required.
• Hospital utilization patterns and adherence to post-exposure workflows.
• Inventory and supply continuity (HBIG shortages or allocation affect sales timing).

Pricing power is structurally constrained by:

• Class competition among plasma-derived immunoglobulins and HBIG-branded alternatives.
• Tendering and reimbursement controls in many markets.
• Clinical standardization of prophylaxis dosing regimens that reduce the scope for value-based pricing.

Key implication for financial trajectory: growth is less about label expansion and more about maintaining utilization share, supply reliability, and reimbursement access while navigating category pressure from cost-contained procurement.

Where does competition come from?

Competition in HBIG is typically characterized by:

• Within-class competition (other HBIG brands and licensed generics depending on country).
• Alternative prophylaxis strategies where clinical practice allows deferring HBIG in favor of vaccine completion or antiviral coverage (rule-driven rather than purely clinical).

For business planning, the competitive threat is less about therapeutic substitution across indications and more about whether payers and protocols treat HBIG as:

• Essential in specific risk definitions (stronger demand stability), or
• Discretionary under broader immunization or antiviral coverage rules (weaker demand stability).

How does patent and regulatory reality influence the financial timeline?

HBIG is generally treated as a biologic derived from human plasma with long product lifecycles where market participants depend on:

• BLA/biologics licensing continuity,
• Manufacturing approvals and lot release consistency,
• Ongoing plasma supply and viral safety controls, and
• Regulatory compliance across the lifecycle (label maintenance, manufacturing changes, and pharmacovigilance).

As a result, financial trajectories tend to show a pattern:

1. Stable revenue while the product is the default prophylaxis option within major formularies.
2. Erosion where generics or competing HBIG products enter through approvals and tender awards.
3. Plateau or decline when substitution and cost containment expand, even if total prophylaxis need remains.

What do global reimbursement and tender dynamics imply for margins?

Because HBIG is used through hospital and payer protocols, margins are sensitive to:

• Tender pricing (often multi-year awards).
• Distribution contracts that can change effective net price.
• Regulatory inspection outcomes that affect manufacturing continuity and supply allocation.
• Plasma cost and fractionation economics which pressure gross margin during plasma-tight cycles.

Financial trajectory risk profile:

• Sales continuity risk: supply interruptions can create demand loss that does not fully recover.
• Net revenue volatility: tender cycles create step-downs in realized price even when volumes stay stable.
• Cost inflation risk: plasma sourcing costs and manufacturing overhead can compress margins.

How is the category affected by hepatitis B prevention strategy shifts?

A core category reality is that vaccination and antiviral strategies reduce hepatitis B transmission and chronic infection incidence. That can indirectly soften HBIG use over time, but HBIG persists because prophylaxis is still needed where:

• Immunization is incomplete or unknown,
• Exposure occurs in high-risk contexts, and
• Clinical guidance mandates immediate passive immunization.

So the category does not collapse. It tends to shrink at the margin when:

• Immunization coverage improves,
• Screening reduces “source unknown” scenarios, and
• Exposure management becomes more tightly governed around vaccine response.

What is the likely financial trajectory (revenue, price, and unit volume) for HBIG?

Without relying on forward-looking speculation, the category-level trajectory is best modeled as a three-variable system:

Variable	Expected direction	What drives the movement
Realized net price	Down or flat	Tendering, competition, reimbursement controls
Unit demand	Flat to modestly down	Better vaccination coverage, improved screening
Volume volatility	Elevated	Inventory cycles, supply continuity events, tender timing

In practice, HBIG financial paths typically show:

• Near-term stability tied to ongoing protocol use and hospital purchasing cadence.
• Mid-cycle price pressure as competing HBIG products and lower-cost alternatives secure formularies.
• Long-cycle volume pressure from improved hepatitis B prevention coverage, reducing prophylaxis-triggering scenarios.

How does utilization map to revenue sensitivity?

Revenue sensitivity is high to changes in:

• Dose per treated exposure, which is protocol-defined and depends on the risk category of the source and patient immunity.
• Treatment eligibility rules (e.g., what qualifies as high-risk exposure, what constitutes inadequate immune response, and how “unknown” source cases are handled).

The most actionable business lens for HBIG is not “market growth.” It is:

• Protocol adherence intensity in target geographies,
• Tender award execution (penetration and retention),
• Supply reliability (fill rates and continuity).

What does the balance between supply and demand mean for execution risk?

HBIG is plasma-derived. Execution risk concentrates in:

• Plasma supply availability (upstream).
• Manufacturing batch release (downstream).
• Regulatory compliance across facilities and process changes.
• Allocation management during constraints.

Financial outcomes track execution. A category can have stable underlying need but still underperform if supply constraints force:

• missed orders,
• substitution to competing products,
• lost tender allocations.

Key business implications for investors and R&D planners

• HBIG is a systems product: revenue is driven by protocols, tenders, and hospital inventory behavior.
• Growth is less about new clinical claims and more about securing and maintaining net price and access.
• Margins are structurally exposed to plasma sourcing and tender resets.
• Supply continuity is a financial lever: reliability drives repeat ordering and retention through tender cycles.

Key Takeaways

• Hepatitis B immune globulin (human) is a protocol-driven market with demand anchored to post-exposure and perinatal prevention, making revenue sensitive to tender awards, reimbursement rules, and supply continuity.
• Realized pricing is typically constrained by procurement dynamics, while volume trends align with the maturity of hepatitis B prevention programs (vaccination and screening).
• Financial trajectory generally follows a pattern of revenue stability followed by periodic price erosion and mild volume pressure, with execution and supply reliability determining realized performance.

FAQs

1) Is HBIG demand primarily driven by epidemiology or clinical practice?

Clinical practice and protocol eligibility drive demand more directly than epidemiology because HBIG use is triggered by exposure and risk definitions embedded in healthcare workflows.

2) What most often determines HBIG financial performance in the near term?

Tendering, formulary access, and net pricing versus competitors, with supply reliability strongly influencing fill rates and the ability to maintain purchasing relationships.

3) Does improved hepatitis B vaccination reduce HBIG use substantially?

It can reduce HBIG use at the margin by lowering inadequate-immunity scenarios, but HBIG persists for defined high-risk exposures and specific prophylaxis pathways where passive immunization is mandated.

4) Where is margin risk concentrated for HBIG?

Margin risk clusters in plasma sourcing and manufacturing economics and in realized net price changes during tender cycles.

5) What business decisions most affect share in HBIG?

Securing and defending procurement positions, maintaining uninterrupted supply, and aligning product availability to hospital ordering cycles and protocol dosing patterns.

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References

[1] U.S. Food and Drug Administration (FDA). (n.d.). Biologics License Applications (BLAs) and labeling for hepatitis B immune globulin (human) products. FDA. https://www.fda.gov/
[2] European Medicines Agency (EMA). (n.d.). EPAR and safety/quality information for hepatitis B immunoglobulin products. EMA. https://www.ema.europa.eu/
[3] Centers for Disease Control and Prevention (CDC). (n.d.). Guidelines for hepatitis B postexposure prophylaxis and immunization recommendations. CDC. https://www.cdc.gov/