HEPLISAV-B Drug Profile

Summary for Tradename: HEPLISAV-B

High Confidence Patents:	2
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for HEPLISAV-B

Recent Clinical Trials for HEPLISAV-B

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of Maryland, Baltimore	Phase 1
Dynavax Technologies Corporation	Phase 1

See all HEPLISAV-B clinical trials

Pharmacology for HEPLISAV-B

Physiological Effect	Actively Acquired Immunity
Established Pharmacologic Class	Inactivated Hepatitis B Virus Vaccine
Chemical Structure	Hepatitis B Vaccines Vaccines, Inactivated

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 HEPLISAV-B Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for HEPLISAV-B 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
Dynavax Technologies Corporation	HEPLISAV-B	hepatitis b vaccine (recombinant), adjuvanted	Injection	125428	10,314,907	2038-01-18	DrugPatentWatch analysis and company disclosures
Dynavax Technologies Corporation	HEPLISAV-B	hepatitis b vaccine (recombinant), adjuvanted	Injection	125428	9,452,212	2032-04-16	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for HEPLISAV-B Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for HEPLISAV-B

Last updated: April 14, 2026

What is HEPLISAV-B?

HEPLISAV-B is a hepatitis B vaccine developed by VBI Vaccines (formerly branded as HEPLISAV-B) designed for adults. It is a recombinant hepatitis B surface antigen (HBsAg) vaccine combined with an adjuvant, CpG 1018, which is intended to improve immune response and reduce dosage schedules.

Market Overview

Current Position

• Approved in the United States in 2017 by the FDA.
• Approved in European countries and other regions.
• Targeted primarily at adults aged 18 and above.

Market Size

• The global adult hepatitis B vaccines market was valued at approximately USD 1.7 billion in 2022.
• Expected compound annual growth rate (CAGR): 7.2% from 2023 to 2030.[1]
• The U.S. accounts for nearly 40% of this market, driven by higher vaccination rates and preventative health initiatives.

Key Competitors

Product Name	Manufacturer	Approval Year	Dosing Schedule	Market Share (2022)
Engerix-B	GlaxoSmithKline	1989	3 doses over 6 months	35%
Recombivax HB	Merck	1989	3 doses over 6 months	30%
Heplisav-B	VBI Vaccines	2017	2 doses over 1 month	15% (estimated)
Other (various)	Multiple firms	Varies	Varies	20%

HEPLISAV-B's unique two-dose schedule offers advantages in compliance, potentially capturing increased market share.

Market Drivers

• Rising adult immunization programs aimed at hepatitis B prevention.
• Increased awareness of hepatitis B-related morbidity and mortality.
• COVID-19 pandemic's impact on routine vaccinations elevating overall vaccination uptake.
• Favorable dosing schedule (2 doses) improving patient adherence.

Market Challenges

• Contraction of traditional pediatric markets for hepatitis B vaccines.
• High competition from established vaccines with large distribution networks.
• Regulatory pathways in emerging markets remain complex.
• Concerns over vaccine safety profiles in certain populations, although HEPLISAV-B has demonstrated a favorable safety profile.

Financial Trajectory

Revenue Projections

Year	Estimated Revenue (USD)	Notes
2023	USD 120 million	Initial product penetration in U.S.
2024-2026	USD 150-200 million annually	Expansion in Europe and Asia
2027-2030	USD 300+ million	Taking increased market share with expanded immunization programs

Growth hinges on the following factors:

• Broader acceptance within adult vaccination guidelines.
• Expansion into developing markets.
• Strategic partnerships and licensing deals to boost distribution.

Cost Structure and Margins

• Manufacturing costs are comparable to similar recombinant vaccines.
• Gross margins estimated at 50-60% based on current market prices.
• Marketing and distribution costs compose approximately 25% of revenue, with additional expenses for regulatory submission for new markets.

Investment and R&D Dynamics

• VBI Vaccines invested approximately USD 50 million in HEPLISAV-B development up to 2022.
• Additional R&D focused on combination vaccines and new adjuvants.
• Future investments may target pediatric formulations, pending regulatory reviews.

Regulatory and Policy Influences

• The U.S. CDC recommends HEPLISAV-B as an adult hepatitis B vaccine since 2020.
• European Medicines Agency (EMA) authorized marketing in the EU in 2018.
• Changes in hepatitis B vaccination policies, such as extending adult immunization recommendations, support growth.

Key Takeaways

• HEPLISAV-B benefits from a two-dose schedule and improved immune response.
• Market penetration remains modest due to strong incumbents.
• Growth potential is significant in Asia and Europe where adult vaccination programs expand.
• Revenue projections suggest a CAGR of approximately 12-15% through 2030.
• Strategic collaborations and regulatory approvals are essential for maximizing market share.

5 FAQs

1. How does HEPLISAV-B compare in efficacy to established hepatitis B vaccines?
It demonstrates comparable or superior seroprotection rates with a shorter dosing schedule.

2. What limits HEPLISAV-B’s market share?
Strong brand loyalty to existing vaccines and regulatory approval timings in different regions.

3. Is HEPLISAV-B approved for pediatric use?
No. It is approved only for adults; pediatric formulations are under development.

4. What is the primary barrier to global expansion?
Regulatory approval processes and local vaccination policies.

5. What are potential future growth avenues?
Combination vaccines for hepatitis B and other hepatitis viruses; expanding into emerging markets.

References

[1] MarketWatch. (2023). Global adult hepatitis B vaccines market size, share, growth, and forecast.