TRUMENBA Drug Profile

Summary for Tradename: TRUMENBA

High Confidence Patents:	10
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for TRUMENBA

Recent Clinical Trials for TRUMENBA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Sanofi Pasteur, a Sanofi Company	Phase 1/Phase 2

See all TRUMENBA clinical trials

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 TRUMENBA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for TRUMENBA 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
Wyeth Pharmaceuticals Llc	TRUMENBA	meningococcal group b vaccine	Injection	125549		2036-05-16	DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Llc	TRUMENBA	meningococcal group b vaccine	Injection	125549		2034-12-04	DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Llc	TRUMENBA	meningococcal group b vaccine	Injection	125549		2040-10-30	DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Llc	TRUMENBA	meningococcal group b vaccine	Injection	125549		2037-11-02	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for TRUMENBA 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
Wyeth Pharmaceuticals Llc	TRUMENBA	meningococcal group b vaccine	Injection	125549		2035-11-13	Patent claims search
Wyeth Pharmaceuticals Llc	TRUMENBA	meningococcal group b vaccine	Injection	125549		2037-06-06	Patent claims search
Wyeth Pharmaceuticals Llc	TRUMENBA	meningococcal group b vaccine	Injection	125549		2034-04-23	Patent claims search

International Patents for TRUMENBA

Country	Patent Number	Estimated Expiration
Canada	2770304
Australia	2014222308
Eurasian Patent Organization	201990091
European Patent Office	2461825

Market Dynamics and Financial Trajectory for TRUMENBA

Last updated: February 20, 2026

What is the market position of TRUMENBA in meningococcal vaccine space?

TRUMENBA (meningococcal Group B vaccine, also known as 4CMenB) is a biosynthetic vaccine developed by GlaxoSmithKline (GSK). Approved by the FDA in 2015, it targets serogroup B strains of Neisseria meningitidis, which are not covered by quadrivalent vaccines that target serogroups A, C, W, and Y. It is designed for use in adolescents, ideally starting at age 10, and for certain high-risk groups.

How does TRUMENBA compare to competitors in the meningococcal B vaccine market?

The primary competitor to TRUMENBA is Bexsero, developed by Novartis (later acquired by GSK). Both vaccines:

• Are approved for similar age groups.
• Use different antigens: TRUMENBA uses outer membrane vesicles (OMV) combined with protein antigens, and Bexsero combines outer membrane vesicle with recombinant proteins.
• Have similar efficacy profiles but differ in immunogenicity data and licensing indications.
• Are recommended for immunization in regions with high incidence of meningococcal B disease.

Bexsero maintained a marginal market lead in certain markets until GSK's late-entry and aggressive pricing strategies for TRUMENBA increased competition. Market penetration varies by country, influenced by local guidelines.

What are the key market drivers for TRUMENBA?

1. Rising incidence of meningococcal B disease, especially in Europe and North America.
2. Increasing vaccination recommendations by health authorities targeting adolescents and high-risk populations.
3. Market exclusivity and patent protections, extending through 2030s.
4. Manufacturer's strategic collaborations and pricing negotiations with government health agencies.
5. Growing awareness of meningococcal disease severity, prompting adoption of vaccines.

What are significant market challenges and constraints?

• Limited global demand: Meningococcal B disease has a relatively low incidence, limiting volume potential.
• Cost and reimbursement: High vaccine prices impact procurement, especially in public health sectors.
• Competition: Bexsero and other vaccines, plus upcoming candidates, threaten market share.
• Regulatory variations: Some countries delay adoption due to differing national immunization policies and cost-effectiveness evaluations.

How has TRUMENBA performed financially since its launch?

GSK reports financial data for TRUMENBA within its vaccines segment. Key financial insights include:

Year	Revenue (USD millions)	Market Penetration	Notes
2015 (launch)	Data not disclosed	Limited initial uptake	First marketed in US and Europe
2016–2018	Growth at mid-single digits	Steady expansion in US and some European markets	Sales driven by vaccination recommendations
2019–2021	Diversified markets, slow growth	Market saturation approaches	Competition from Bexsero affected sales
2022 onward	Market stabilization, some growth	Growing acceptance in emerging markets	New licensing agreements and booster strategies

Revenues from TRUMENBA remain a portion of GSK's vaccines division, which reports total sales around GBP 4 billion (~USD 5.2 billion) in 2022.

What are prospects for future revenue growth?

Potential growth avenues include:

• Expanded indications, including booster doses.
• Adoption in emerging markets due to GSK's licensing agreements.
• Combination vaccine formulations combining MenB and other meningococcal strains.
• Integration into broader adolescent immunization programs.

Market analysts project moderate growth averaging 3–5% annually over the next 5 years, contingent upon regulatory approvals and epidemiological trends.

How do regulatory policies affect TRUMENBA's financial trajectory?

Increased regulatory approvals in Asia, Latin America, and Africa could expand access. Conversely, delays or restrictions in vaccine reimbursement can restrain revenue growth. Several countries with high disease burden are evaluating cost-effectiveness data to determine inclusion in national immunization programs.

Key Takeaways

• TRUMENBA is a leading MenB vaccine with a solid market position but faces competition and low disease incidence limiting rapid growth.
• GSK's strategic efforts, including licensing in emerging markets, could expand the global reach.
• Pricing, reimbursement policies, and local regulatory decisions substantially influence revenue.

What are five FAQs about TRUMENBA market and financial outlook?

Q1: What distinguishes TRUMENBA from Bexsero in terms of market share?

A1: Market share varies by region; Bexsero led initially, but GSK's targeted pricing and licensing agreements for TRUMENBA have increased its penetration, especially in Europe and North America.

Q2: How significant are reimbursement policies for TRUMENBA sales?

A2: Reimbursement significantly impacts uptake; high vaccine prices can restrict adoption unless covered by strong public health funding or insurance.

Q3: Are there plans for new formulations or fixed-dose combinations?

A3: There are ongoing research and development efforts, including booster doses and combination vaccines, which could influence future revenues.

Q4: What is the impact of disease epidemiology on TRUMENBA sales?

A4: Fluctuations in meningococcal B disease incidence influence demand; outbreak periods lead to increased sales, while steady low incidence restrains growth.

Q5: How does GSK's pipeline and licensing strategy impact TRUMENBA's future?

A5: Licensing agreements in emerging markets extend access and revenue opportunities, but pipeline advancements and regulatory approvals are crucial for sustained growth.

[1] GSK. (2023). Annual Report 2022. Retrieved from https://www.gsk.com/en-gb/investors/annual-report-2022/