MENACTRA Drug Profile

Summary for Tradename: MENACTRA

High Confidence Patents:	3
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for MENACTRA

Recent Clinical Trials for MENACTRA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1
Rodolphe Merieux Laboratory@@@Bamako, Mali	Phase 1

See all MENACTRA clinical trials

Pharmacology for MENACTRA

Physiological Effect	Actively Acquired Immunity
Established Pharmacologic Class	Inactivated Meningococcal Vaccine
Chemical Structure	Meningococcal 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 MENACTRA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for MENACTRA 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
Sanofi Pasteur Inc.	MENACTRA	meningococcal (groups a, c, y and w-135) polysaccharide diphtheria toxoid conjugate vaccine	For Injection	125089	10,617,766	2038-10-29	DrugPatentWatch analysis and company disclosures
Sanofi Pasteur Inc.	MENACTRA	meningococcal (groups a, c, y and w-135) polysaccharide diphtheria toxoid conjugate vaccine	For Injection	125089	7,491,517	2027-02-28	DrugPatentWatch analysis and company disclosures
Sanofi Pasteur Inc.	MENACTRA	meningococcal (groups a, c, y and w-135) polysaccharide diphtheria toxoid conjugate vaccine	For Injection	125089	8,734,813	2033-03-15	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for MENACTRA 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
Sanofi Pasteur Inc.	MENACTRA	meningococcal (groups a, c, y and w-135) polysaccharide diphtheria toxoid conjugate vaccine	For Injection	125089	10,016,338	2036-12-20	Patent claims search
Sanofi Pasteur Inc.	MENACTRA	meningococcal (groups a, c, y and w-135) polysaccharide diphtheria toxoid conjugate vaccine	For Injection	125089	10,577,154	2038-12-19	Patent claims search
Sanofi Pasteur Inc.	MENACTRA	meningococcal (groups a, c, y and w-135) polysaccharide diphtheria toxoid conjugate vaccine	For Injection	125089	10,912,714	2038-07-09	Patent claims search
Sanofi Pasteur Inc.	MENACTRA	meningococcal (groups a, c, y and w-135) polysaccharide diphtheria toxoid conjugate vaccine	For Injection	125089	9,554,968	2034-03-11	Patent claims search
Sanofi Pasteur Inc.	MENACTRA	meningococcal (groups a, c, y and w-135) polysaccharide diphtheria toxoid conjugate vaccine	For Injection	125089	9,662,450	2034-02-28	Patent claims search

International Patents for MENACTRA

Country	Patent Number	Estimated Expiration
South Africa	200900182
Belgium	2012C050
Spain	2388848
World Intellectual Property Organization (WIPO)	2008011201
South Korea	100947751
Lithuania	5177

Supplementary Protection Certificates for MENACTRA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
12C0072	France		PRODUCT NAME: OLIGOSIDE DE NEISSERIA MENINGITIDIS DE GROUPE A CONJUGUE A LA PROTEINE CRM-197 DE CORYNEBACTERIUM DIPHTHERIAE - OLIGOSIDE DE NEISSERIA MENINGITIDIS DU GROUPE C CONJUGUE A LA PROTEINE CRM-197 DE CORYNEBACTERIUM DIPHTHERIAE -OLIGOSIDE DE NEISSERIA MENINGITIDIS DE GROUPE W135 CONJUGUE A LA PROTEINE CRM-197 DE CORYNEBACTERIUM DIPHTHERIAE - OLIGOSIDE D; REGISTRATION NO/DATE: EU/1/10/614/001 20100317
51/2012	Austria		PRODUCT NAME: MENINGOKOKKEN-GRUPPE A OLIGOSACCHARID KONJUGIERT AN CORYNEBACTERIUM DIPHTHERIAE CRM197-PROTEIN, MENINGOKOKKEN-GRUPPE C OLIGOSACCHARID KONJUGIERT AN CORYNEBACTERIUM DIPHTHERIAE CRM197-PROTEIN, MENINGOKOKKEN-GRUPPE W135 OLIGOSACCHARID KONJUGIERT AN CORYNEBACTERIUM DIPHTHERIAE CRM197-PROTEIN, MENINGOKOKKEN-GRUPPE Y OLIGOSACCHARID KONJUGIERT AN CORYNEBACTERIUM DIPHTHERIAE CRM197-PROTEIN.; REGISTRATION NO/DATE: EU/1/10/614/001 20100315
122022000001	Germany		PRODUCT NAME: POLYSACCHARID VON NEISSERIA MENINGITIDIS DER GRUPPE A, KONJUGIERT AN TETANUSTOXOID-TRAEGERPROTEIN, POLYSACCHARID VON NEISSERIA MENINGITIDIS DER GRUPPE C, KONJUGIERT AN TETANUSTOXOID-TRAEGERPROTEIN, POLYSACCHARID VON NEISSERIA MENINGITIDIS DER GRUPPE Y, KONJUGIERT AN TETANUSTOXOID-TRAEGERPROTEIN, POLYSACCHARID VON NEISSERIA MENINGITIDIS DER GRUPPE W, KONJUGIERT AN TETANUSTOXOID-TRAEGERPROTEIN, WOBEI NU; REGISTRATION NO/DATE: EU/1/20/1483 20201118
C300555	Netherlands		PRODUCT NAME: COMBINATIE VAN MENINGOKOKKAAL GROEP A OLIGOSACHARIDE GECONJUGEERD MET EM CORYNEBACTERIUM DIPTHERIE /EM CRM197 EIWIT, MENINGOKOKKAAL GROEP C OLIGOSACHARIDE GECONJUGEERD MET EM CORYNEBACTERIUM DIPTHERIE /EM CRM197 EIWIT,; REGISTRATION NO/DATE: EU/1/10/614/001 20100315
2012C/050	Belgium		PRODUCT NAME: OLIGOSACCHARIDE MENINGOCOCCIQUE DU GROUPE A, C, W135 ET Y CONJUGUE A LA PROTEINE CRM197 DE CORYNEBACTERIUM DIPHTHERIAE; AUTHORISATION NUMBER AND DATE: EU/1/10/614/001 20100317
2015/072	Ireland		PRODUCT NAME: MENINGOCOCCAL GROUP C OLIGOSACCHARIDE CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE CRM 197 PROTEIN, MENINGOCOCCAL GROUP W135 OLIGOSACCHARIDE CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE CRM 197 PROTEIN AND MENINGOCOCCAL GROUP Y OLIGOSACCHARIDE CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE CRM 197 PROTEIN; REGISTRATION NO/DATE: EU/1/10/614/001 20100315

Market Dynamics and Financial Trajectory for MENACTRA (Menactra)

Last updated: September 23, 2025

Introduction

MENACTRA (meningococcal conjugate vaccine, serogroups A, C, W, and Y) has established a prominent role in preventing invasive meningococcal disease (IMD). Since its approval, MENACTRA has experienced evolving market dynamics driven by epidemiological trends, vaccine policies, technological advancements, and competitive forces. Analyzing its financial trajectory provides insight into its commercial sustainability and growth prospects within the complex landscape of infectious disease prophylactics.

Market Overview

Epidemiology and Public Health Demand

Meningococcal disease, although relatively rare, presents a high case fatality rate and significant morbidity. The global burden predominantly affects infants, adolescents, and young adults, with outbreaks often linked to serogroups A, C, W, and Y. Regions like sub-Saharan Africa (notably the "meningitis belt") face sustained epidemics, fueling demand for effective vaccination strategies [1].

Regulatory and Policy Environment

Major markets, including the United States, European Union, and parts of Asia, have integrated MENACTRA into their routine immunization schedules for adolescents and high-risk groups. Government policies and recommendations by health authorities (e.g., CDC, WHO) significantly influence uptake levels, resource allocation, and market growth [2].

Supply and Manufacturing Dynamics

As a conjugate vaccine, MENACTRA benefits from established manufacturing technology but faces challenges related to supply chain constraints and scalability, especially during outbreak periods. Patent protections and licensing agreements with key manufacturers also shape availability and pricing strategies.

Competitive Landscape

Key Competitors

MENACTRA primarily competes with other meningococcal vaccines, such as:

• Menveo (MenACWY-CRM conjugate vaccine) by GlaxoSmithKline
• Nimenrix by Pfizer
• Bexsero and Trumenba (though targeting serogroup B, impacting overall meningococcal vaccine markets)

The competitive advantage of MENACTRA lies in its long-standing FDA approval (2005) and broad serogroup coverage, which appeals to health authorities emphasizing comprehensive protection [3].

Market Penetration and Adoption

Market penetration varies by country, influenced by:

• Vaccine approval timelines; MENACTRA was among the first conjugate vaccines in the US.
• Public health campaigns; mass immunization drives increase demand.
• Pricing and reimbursement policies; impact accessibility, especially in developing regions.

Financial Trajectory

Revenue Trends

Initially launched with moderate sales, MENACTRA’s revenues surged following inclusion in routine vaccination schedules and outbreak responses. For instance, in the US, vaccination coverage of adolescents increased incrementally, bolstering sales [4].

In recent years, revenue growth has decelerated due to:

• Market saturation in high-income countries.
• Emergence of competitors with comparable efficacy and pricing.
• Pandemic-related disruptions impacting routine immunizations globally.

Pricing Strategies and Reimbursement

Pricing varies significantly across markets, with tiered strategies to balance profitability and affordability. Reimbursement rates provided by government programs like Medicaid in the US and national immunization programs in Europe heavily influence revenue flows.

Research and Development (R&D) Investment

Ongoing R&D efforts aim to extend MENACTRA’s profile, including multivalent formulations and combination vaccines. Although these initiatives entail substantial costs, successful innovation can provide premium pricing and expanded market share.

Regulatory Milestones and Impact

Approvals for novel formulations or expanded age groups can significantly impact financial performance. For example, extending vaccination to younger infants or adult populations broadens target demographics and revenue potential.

Market Challenges and Opportunities

Challenges

• Vaccine Hesitancy: Public skepticism and misinformation can dampen uptake.
• Pricing Pressures: Governments and payers demand cost-effective solutions amid constrained healthcare budgets.
• Serogroup Epidemiology: Shifts in circulating strains may necessitate reformulation or new vaccine development.
• Global Access: Lower-income countries face financial and logistical barriers to vaccine adoption despite high disease burden.

Opportunities

• New Indications: Expanding age indications or booster schedules.
• Region Expansion: Penetrating emerging markets like Southeast Asia, Latin America.
• Technological Innovation: Developing thermostable formulations and single-dose regimens enhances accessibility.
• Partnerships: Alliances with GAVI, UNICEF, and other agencies facilitate broader distribution.

Future Financial Trajectory

Given the current landscape, MENACTRA’s revenue growth trajectory will likely stabilize in mature markets, with incremental gains from new indications and formulations. Expansion into lower-income regions, supported by global health initiatives, can drive substantial volume growth. Nonetheless, intensifying competition and pricing pressures necessitate continuous innovation and strategic collaborations.

Projected revenues should consider:

• Market saturation in high-income settings.
• Emerging market growth potential, potentially doubling market size over the next decade.
• R&D pipeline success, which can unlock new revenue streams and extend product lifecycle.

Conclusion

MENACTRA’s market dynamics are shaped by epidemiological trends, evolving immunization policies, technological advancements, and competitive forces. Its financial trajectory reflects maturity in certain regions, with growth opportunities mainly stemming from expansion into underserved markets and ongoing innovation. Companies leveraging strategic partnerships and adaptive pricing models can sustain revenue streams amid increasing competition and changing global health landscapes.

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Key Takeaways

• MENACTRA remains a staple in meningococcal disease prevention, with a stable market in high-income countries.
• Regional epidemiology and public health policies are pivotal in shaping demand and revenue.
• Competitive pressures and vaccine hesitancy pose ongoing challenges to market expansion.
• Opportunities exist in emerging markets and through innovation in vaccine formulations.
• Sustained R&D investment and strategic collaborations are critical to extending the product's financial viability.

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FAQs

1. How has MENACTRA performed in the global meningococcal vaccine market?
MENACTRA is historically one of the leading vaccines, especially in North America and Europe, due to its early approval and comprehensive serogroup coverage. Its performance in emerging markets is improving, driven by global health initiatives and increasing awareness.

2. What factors influence the pricing and reimbursement of MENACTRA?
Pricing is influenced by manufacturing costs, regional regulatory policies, competition, and negotiations with healthcare payers. Reimbursement depends on government policies, disease burden, and the perceived value of the vaccine within immunization programs.

3. How does the emergence of new meningococcal vaccines impact MENACTRA’s market share?
New entrants, especially those offering improved formulations or broader coverage, can erode MENACTRA’s market share by providing alternatives that appeal to healthcare providers and governments seeking cost-effective or broader protection.

4. What are the primary growth opportunities for MENACTRA moving forward?
Expanding into low- and middle-income countries, developing multivalent or thermostable versions, and securing regulatory approvals for new age indications offer significant growth avenues.

5. What role do global health initiatives play in MENACTRA’s market development?
Organizations like GAVI prioritize meningococcal vaccines for high-burden regions, facilitating large-volume purchases and subsidized pricing, which accelerates MENACTRA’s market penetration in underserved populations.

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Sources:

[1] World Health Organization. Meningococcal Disease Fact Sheet. (2022).
[2] CDC Immunization Schedules. (2023).
[3] U.S. Food and Drug Administration. Menactra Approval Details. (2005).
[4] Johnson et al., Market Trends in Meningococcal Vaccines. Vaccine Journal. (2021).