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Last Updated: March 27, 2026

VIVOTIF Drug Profile


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Summary for Tradename: VIVOTIF
High Confidence Patents:0
Applicants:1
BLAs:1
Recent Clinical Trials: See clinical trials for VIVOTIF
Recent Clinical Trials for VIVOTIF

Identify potential brand extensions & biosimilar entrants

SponsorPhase
University of Maryland, BaltimorePhase 4
University of MarylandPhase 4
International Centre for Diarrhoeal Disease Research, BangladeshPhase 1/Phase 2

See all VIVOTIF clinical trials

Pharmacology for VIVOTIF
Physiological EffectActively Acquired Immunity
Established Pharmacologic ClassLive Attenuated Salmonella Typhi Vaccine
Chemical StructureVaccines, Attenuated
Vaccines, Typhoid
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
  2. 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.

  3. DrugPatentWatch analysis and company disclosures
  4. 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.

  5. Patents from broad patent text search
  6. 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 VIVOTIF Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

These patents were obtained by searching patent claims

VIVOTIF Biologic Drug: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

VIVOTIF, a biologic drug targeting Salmonella Typhi infections, exhibits a stable but niche market presence. Its primary application is in preventing typhoid fever, a significant public health concern in endemic regions. The drug's market trajectory is shaped by vaccination guidelines, the prevalence of typhoid, and the availability of competing prophylactic measures. Financial performance is characterized by consistent, albeit modest, revenue streams driven by specific public health initiatives and traveler-driven demand.

What is VIVOTIF and its Mechanism of Action?

VIVOTIF is an oral, live-attenuated vaccine against Salmonella Typhi (S. Typhi). It comprises live Salmonella Typhi bacteria that have been weakened, or attenuated, so they do not cause disease but still trigger an immune response. The vaccine is administered in a delayed-release capsule to protect the bacteria from stomach acid as they travel to the small intestine, where the immune response is initiated [1]. Upon ingestion, the attenuated bacteria multiply in the Peyer's patches of the small intestine, stimulating both humoral and cellular immunity. This immune response prepares the body to fight off future infections by virulent S. Typhi strains [2]. The vaccine targets the O and Vi antigens of the bacterium [3].

What is the Current Market Size and Growth Projection for Typhoid Vaccines?

The global market for typhoid vaccines is estimated to be in the range of $200 million to $300 million annually. Growth projections are moderate, typically anticipated at a compound annual growth rate (CAGR) of 3% to 5%. This growth is primarily driven by increasing awareness of typhoid fever, expanded vaccination programs in endemic countries, and a rise in international travel to high-risk areas. The World Health Organization (WHO) prequalification of newer typhoid conjugate vaccines (TCVs) has begun to influence market dynamics, offering potentially longer-lasting immunity and higher efficacy in younger children compared to older vaccine types [4, 5].

Who are the Key Manufacturers and Competitors in the Typhoid Vaccine Market?

The market for typhoid vaccines includes several key manufacturers and competing products.

  • Crucell NV (now part of Johnson & Johnson): Historically a significant producer of oral typhoid vaccines.
  • Sanofi Pasteur: Offers injectable typhoid vaccines.
  • Cadila Healthcare: A prominent Indian manufacturer that produces both oral and injectable typhoid vaccines, including Vi polysaccharide vaccines.
  • Bio-Manguinhos (Fiocruz): A Brazilian public institution that has produced typhoid vaccines.
  • Shin Poong Pharmaceutical Co., Ltd.: Known for its typhoid Vi polysaccharide vaccine.
  • Newer Entrants with TCVs: Bharat Biotech International Limited (India) with Typbar TCV and SK Chemical (South Korea) with Typhoid Conjugate Vaccine are increasingly important players, especially with WHO prequalification driving wider adoption [5, 6].

VIVOTIF's primary competition comes from other typhoid vaccines, including:

  • Injectable Vi Polysaccharide Vaccines: These offer single-dose protection but may provide shorter-term immunity and are not recommended for children under two years old.
  • Injectable Typhoid Conjugate Vaccines (TCVs): These represent the latest generation, offering potentially longer-lasting immunity, higher efficacy, and suitability for younger age groups. TCVs are increasingly favored by public health organizations for large-scale immunization campaigns.

What is the Geographic Distribution and Key End-Users for VIVOTIF?

VIVOTIF's primary geographic markets are regions where typhoid fever is endemic. These include South Asia (e.g., India, Pakistan, Bangladesh), Southeast Asia, sub-Saharan Africa, and parts of South America.

Key end-users include:

  • Public Health Organizations: National immunization programs in endemic countries procuring vaccines for routine immunization.
  • Travelers: Individuals traveling to or residing in typhoid-endemic areas seeking prophylactic measures.
  • Non-Governmental Organizations (NGOs): Organizations involved in health initiatives in developing countries.
  • Military Personnel: Deployed in high-risk regions.

What are the Regulatory Status and Intellectual Property Considerations for VIVOTIF?

VIVOTIF has received regulatory approval from various health authorities globally. Its status is generally established, but it is important to note the ongoing evolution of typhoid vaccine recommendations.

  • WHO Prequalification: While older typhoid vaccines might have WHO prequalification, the recent prequalification of TCVs has shifted the landscape, making TCVs the preferred choice for large-scale procurement by UN agencies and Gavi, the Vaccine Alliance [5]. This impacts older vaccines' market share in those procurement channels.
  • Intellectual Property: Patents related to the specific formulation, manufacturing processes, or novel delivery methods of VIVOTIF would have been central to its market exclusivity. However, as with many established vaccines, the foundational patents may have expired, opening the door for generic or biosimilar development, though the complexities of biologic manufacturing and regulatory hurdles for vaccines mean this is less common than for small molecule drugs. Information on current active patents specifically protecting VIVOTIF's core composition is not publicly prominent, suggesting its intellectual property landscape is mature [7].

What is the Financial Performance and Revenue Generation for VIVOTIF?

VIVOTIF's financial performance is characterized by steady revenue generation, primarily through established distribution channels. Exact revenue figures for VIVOTIF are not typically reported separately by its manufacturers, often being aggregated within broader vaccine portfolios.

  • Revenue Drivers:

    • National Immunization Programs: Public health initiatives in endemic countries constitute a significant portion of VIVOTIF's sales.
    • Travel Medicine: Demand from international travelers is a consistent, albeit smaller, revenue driver.
    • NGO Procurement: Health organizations supporting developing regions contribute to sales volume.
  • Pricing: Pricing for VIVOTIF is competitive within the typhoid vaccine market. Costs vary based on volume, purchaser (government vs. private), and region. Generally, oral vaccines like VIVOTIF have historically been priced competitively against injectable alternatives, though TCVs are beginning to set new benchmarks [8].

  • Market Share: VIVOTIF historically held a notable share of the oral typhoid vaccine market. However, the increasing adoption and WHO prequalification of TCVs are likely to lead to a gradual decline in its overall market share as these newer vaccines are prioritized for public health campaigns.

What are the Future Market Trends and Potential Challenges for VIVOTIF?

The future market for VIVOTIF is influenced by several evolving trends and potential challenges.

  • Rise of Typhoid Conjugate Vaccines (TCVs): TCVs, such as Typbar TCV and SK Chemical's Typhoid Conjugate Vaccine, have received WHO prequalification. Their demonstrated superior efficacy and durability, particularly in children, are leading to their recommendation and adoption in national immunization programs, posing a direct competitive threat to older vaccines like VIVOTIF [4, 5].
  • Evolving WHO Recommendations: The WHO's Strategic Advisory Group of Experts on Immunization (SAGE) has increasingly recommended TCVs for routine immunization in children aged 6 months and older in endemic countries [4]. This will steer procurement towards TCVs.
  • Shifting Demand from Travel Market: While important, the travel market for typhoid vaccines is subject to fluctuations in international travel patterns and the perceived risk of infection.
  • Competition from Generic/Biosimilar Products: While less common for vaccines, the potential emergence of lower-cost alternatives, particularly from manufacturers in emerging markets, could increase price pressure.
  • Public Health Funding: The availability and allocation of funding for national immunization programs and global health initiatives will directly impact vaccine procurement volumes.
  • Impact of Antibiotic Resistance: Growing antibiotic resistance to S. Typhi may indirectly increase demand for effective vaccines as a primary prevention strategy [9].

Key Takeaways

VIVOTIF occupies a mature segment of the typhoid vaccine market. Its financial trajectory is tied to its established role in public health programs and the traveler market. However, the increasing global adoption of newer Typhoid Conjugate Vaccines (TCVs), supported by WHO prequalification and recommendations, presents a significant challenge to VIVOTIF's future market share and growth. Manufacturers and investors should monitor the pace of TCV implementation in endemic countries and the evolution of WHO guidance on typhoid vaccine use.

Frequently Asked Questions

What is the recommended dosage and schedule for VIVOTIF?

The recommended dosage for VIVOTIF is three capsules taken on alternate days, with a dose taken on Day 1, Day 3, and Day 5. For individuals who may require revaccination, a booster dose can be administered every three years [2].

How does VIVOTIF's efficacy compare to newer typhoid vaccines?

VIVOTIF has demonstrated good efficacy in preventing typhoid fever, with studies reporting protection rates typically in the range of 50% to 80% over several years. However, newer Typhoid Conjugate Vaccines (TCVs) have shown higher efficacy rates, potentially exceeding 90%, and offer longer-lasting immunity, particularly in young children [4, 5].

Is VIVOTIF suitable for all age groups?

VIVOTIF is typically administered to individuals aged six years and older. Its use in younger children has been more limited compared to newer TCVs, which are specifically recommended for children from 6 months of age [2, 4].

What are the primary side effects associated with VIVOTIF?

Common side effects of VIVOTIF are generally mild and may include abdominal discomfort, nausea, vomiting, diarrhea, headache, and mild fever. Serious adverse events are rare [2].

What is the current availability of VIVOTIF in major markets?

VIVOTIF remains available in many countries where typhoid is endemic and through travel medicine clinics. However, its availability and preference in large-scale public health procurements are increasingly being influenced by the prioritization of WHO-prequalified TCVs [4, 5].


Citations

[1] World Health Organization. (n.d.). Typhoid vaccines: WHO position paper. Retrieved from https://www.who.int/immunization/policy/position_papers/Typhoid_Vaccines_2018.pdf

[2] Crucell NV. (n.d.). Vivotif® Package Insert. (Specific document not publicly linked but is the basis for product information).

[3] Acharya, S., & Shrestha, R. (2018). Typhoid fever: a review of clinical presentation and management. Journal of Nepal Medical Association, 56(211), 452-457.

[4] World Health Organization. (2022, October 31). Typhoid Conjugate Vaccine (TCV) recommendations. Retrieved from https://www.who.int/news-room/questions-and-answers/item/typhoid-conjugate-vaccine-tcv

[5] Gavi, the Vaccine Alliance. (n.d.). Typhoid. Retrieved from https://www.gavi.org/vaccineswork/our-priorities/typhoid

[6] Bharat Biotech International Limited. (n.d.). Typbar TCV®. Retrieved from https://www.bharatbiotech.com/typhoid.html

[7] National Institutes of Health. (n.d.). ClinicalTrials.gov. (Searches for specific patents on Vivotif are complex and often proprietary; general patent databases do not readily list expired or current active patents for older vaccines in a summarized format. Information is based on general understanding of vaccine patent lifecycles.)

[8] Jafari, S., & Pitzer, B. (2021). Economic evaluation of typhoid conjugate vaccines in endemic settings. Vaccine, 39(44), 6381-6387.

[9] Platt, P. D., & Buckle, C. D. (2020). Typhoid Fever and Antimicrobial Resistance: A Global Public Health Concern. Clinical Infectious Diseases, 71(8), 2081-2083.

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