PEDVAXHIB Drug Profile

Summary for Tradename: PEDVAXHIB

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for PEDVAXHIB

Recent Clinical Trials for PEDVAXHIB

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Merck Sharp & Dohme Corp.	Phase 4
Johns Hopkins Bloomberg School of Public Health	Phase 4

See all PEDVAXHIB clinical trials

Pharmacology for PEDVAXHIB

Physiological Effect	Actively Acquired Immunity
Established Pharmacologic Class	Inactivated Haemophilus Influenzae B Vaccine
Chemical Structure	Haemophilus 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:

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.

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.

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 PEDVAXHIB Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

PEDVAXHIB Market Dynamics and Financial Trajectory

Last updated: September 9, 2026

PEDVAXHIB is a mature Haemophilus influenzae type b vaccine marketed by Merck & Co. Its commercial value is supported by routine infant immunization, government procurement, and a differentiated two-dose primary series. Its growth outlook is limited by combination vaccines, a stable-to-declining U.S. birth cohort, and the absence of product-level revenue disclosure. Public filings do not report PEDVAXHIB sales separately, so its standalone financial trajectory cannot be quantified from Merck’s financial statements.

What is PEDVAXHIB and how is it used?

PEDVAXHIB is a monovalent Hib conjugate vaccine containing polyribosylribitol phosphate, or PRP, conjugated to an outer membrane protein complex from Neisseria meningitidis group B. The vaccine is supplied as a liquid formulation for intramuscular injection.

The product’s main clinical and commercial distinction is its two-dose primary series:

Attribute	PEDVAXHIB
Manufacturer	Merck & Co.
Antigen	Haemophilus influenzae type b PRP-OMP
Dosage form	Liquid, single-dose vial or syringe depending on presentation
Primary series	Two doses at 2 and 4 months
Booster	One dose at 12-15 months
Main market	U.S. pediatric routine immunization
Product category	Standalone pediatric Hib vaccine
FDA pathway	Licensed biologic vaccine
Biosimilar exposure	None under the FDA biosimilar framework

The two-dose primary schedule reduces the number of infant visits and injections compared with three-dose primary schedules used by several competing Hib products. CDC guidance permits PEDVAXHIB as a standalone Hib vaccine for infants and toddlers under the routine immunization schedule.[1]

What is the FDA and regulatory status of PEDVAXHIB?

PEDVAXHIB is an FDA-licensed vaccine used in the U.S. routine childhood immunization program. The FDA-approved indication covers active immunization against invasive disease caused by H. influenzae type b in infants and children.

CDC recommendations require Hib vaccination beginning in infancy, generally at 2 months of age. The exact schedule depends on the product used, the child’s age at initiation, and prior doses.[1]

PEDVAXHIB is not a conventional small-molecule drug and is not evaluated through an abbreviated new drug application. It is regulated as a biologic vaccine. Its principal regulatory protections arise from:

FDA licensure and manufacturing compliance.
Product-specific clinical and immunogenicity data.
Control of the biological manufacturing process.
Lot-release and quality-control requirements.
Institutional and government purchasing arrangements.
Provider familiarity with the two-dose primary schedule.

The product’s market position is therefore based more on manufacturing execution, supply reliability, procurement access, and clinical workflow than on active patent exclusivity.

What products compete with PEDVAXHIB?

PEDVAXHIB competes with standalone Hib vaccines and combination vaccines that include Hib antigen.

Product	Manufacturer or marketing group	Hib format	Commercial impact
PEDVAXHIB	Merck	Standalone PRP-OMP	Two-dose primary series
ActHIB	Sanofi	Standalone Hib	Three-dose primary series
Hiberix	GSK	Standalone Hib	Used for primary and booster vaccination
Vaxelis	MCM Vaccine B.V., associated with Merck and Sanofi	Six-component combination vaccine	Bundles Hib with DTaP, IPV, hepatitis B and other antigens
Pentacel	Sanofi	Five-component combination vaccine	Bundles Hib with DTaP and IPV

Combination products are the largest structural threat to standalone Hib demand. Vaxelis and Pentacel reduce the number of separate injections and simplify inventory management for pediatric providers. Their use can displace PEDVAXHIB even when the Hib component itself remains clinically necessary.

PEDVAXHIB retains an advantage where providers prefer a two-dose primary Hib series or where combination-vaccine purchasing is constrained by contract, inventory, or reimbursement conditions.

How large is the PEDVAXHIB market?

The relevant market is the U.S. pediatric Hib immunization market, not the global pharmaceutical market. Hib vaccination is routine in the United States, but the eligible population is limited primarily to annual birth cohorts and catch-up vaccinations.

Demand has several stable characteristics:

Infants remain the core population.
Hib vaccination is embedded in public-sector programs.
The disease burden is low because of high vaccination coverage.
Replacement demand is generated by new birth cohorts rather than chronic treatment.
Combination vaccines increasingly capture the vaccination encounter.

The U.S. birth cohort is broadly mature and has experienced pressure from lower birth rates. That limits volume growth for all pediatric vaccines, including PEDVAXHIB. Catch-up vaccination, delayed immunization, and public-sector purchasing provide some volume stability but do not create a high-growth market.

The global opportunity is narrower than for vaccines such as pneumococcal, HPV, or measles-containing products. Hib vaccines are used internationally, but demand depends heavily on national immunization schedules, public procurement, donor funding, and local manufacturing capacity.

Does Merck disclose PEDVAXHIB revenue?

No. Merck reports revenue for major products and product categories, but PEDVAXHIB is not separately reported in the company’s annual financial statements. Its sales are included within Merck’s broader vaccine portfolio or other pharmaceutical product categories.

Merck’s disclosed vaccine revenue is dominated by higher-value products, particularly Gardasil and Gardasil 9, along with ProQuad, M-M-R II, Varivax, Pneumovax and Vaxneuvance. PEDVAXHIB is not identified as a material standalone revenue driver in those disclosures.[2]

This creates three financial conclusions:

Standalone PEDVAXHIB revenue cannot be calculated reliably from public filings.
PEDVAXHIB is not large enough, or not separately material enough, for Merck to provide product-level reporting.
Merck’s corporate vaccine performance is not a reliable proxy for PEDVAXHIB performance.

Any valuation model that assigns PEDVAXHIB a specific revenue figure without company disclosure, contract data, or prescription and shipment data is speculative.

What is the financial trajectory for PEDVAXHIB?

PEDVAXHIB’s likely financial trajectory is mature to declining on a standalone basis.

Volume outlook

Volume is constrained by:

A stable or declining U.S. pediatric birth population.
High vaccination coverage, which limits incremental penetration.
Substitution by Vaxelis and Pentacel.
Provider preference for fewer injections.
Public-health programs that consolidate purchasing across vaccine types.

Volume is supported by:

Continued CDC recommendation for routine Hib vaccination.
The need for catch-up vaccination.
Institutional demand from pediatric practices and health systems.
Public procurement through the Vaccines for Children program.
The product’s two-dose primary schedule.

Pricing outlook

Pricing power is limited. Hib vaccination is a procurement-driven market with significant exposure to:

Federal and state purchasing.
Public-sector contract pricing.
Private insurers and provider reimbursement.
Institutional tenders.
Competitive substitution among licensed products.

A mature vaccine can maintain revenue through price increases even when unit volumes decline, but aggressive pricing is constrained where buyers can shift to other Hib-containing products.

Margin outlook

PEDVAXHIB has characteristics that can support attractive mature-product margins:

Long-established manufacturing processes.
A stable regulatory framework.
Recurring demand.
Limited commercial promotion requirements.
High barriers to entry for new biological manufacturing.

Margins can be pressured by small production runs, fixed manufacturing overhead, quality-control requirements, inventory losses, and the need to maintain supply for a relatively narrow market. If standalone demand falls below efficient manufacturing scale, the product’s strategic value may decline even if it remains clinically useful.

When does PEDVAXHIB lose exclusivity?

PEDVAXHIB does not have a commercially meaningful remaining patent-exclusivity period comparable to a recently launched pharmaceutical.

The product was introduced decades ago. Any original composition, conjugation, formulation, or process patents associated with the original product would generally have expired or become commercially irrelevant. Publicly available product information does not identify an active patent barrier that prevents competing manufacturers from developing Hib vaccines.

The more important barriers are biological manufacturing and regulatory barriers:

Establishing a reproducible conjugation process.
Demonstrating antigen consistency.
Generating pediatric immunogenicity data.
Securing FDA licensure.
Completing facility validation.
Maintaining supply and lot release.
Obtaining government and provider contracts.

Patent expiry therefore does not imply immediate generic entry. A competitor would need to develop and license its own vaccine, not simply copy a small-molecule tablet.

What is the Orange Book and Purple Book status of PEDVAXHIB?

PEDVAXHIB is not an Orange Book small-molecule product. The Orange Book primarily covers approved drugs and therapeutic equivalents under abbreviated applications.[3]

Biological products are generally tracked through FDA biologics databases and the Purple Book framework. PEDVAXHIB does not face a standard interchangeable-biosimilar threat because FDA biosimilar pathways are designed primarily for biologic reference products with suitable follow-on development pathways. Pediatric vaccines have not developed a biosimilar substitution market comparable to insulin, monoclonal antibodies, or certain oncology biologics.[4]

Competitive risk comes from separately licensed vaccines and combination products rather than automatic pharmacy substitution.

Are there Paragraph IV challenges to PEDVAXHIB?

No material public Paragraph IV litigation is associated with PEDVAXHIB.

Paragraph IV certifications apply to abbreviated new drug applications for products listed in the Orange Book. PEDVAXHIB is a licensed biologic vaccine rather than a conventional Orange Book small-molecule product. The absence of Paragraph IV litigation is consistent with the product’s regulatory category.

The relevant competitive events are instead:

New vaccine license applications.
Manufacturing supplements.
Combination-vaccine approvals.
Procurement awards.
Supply disruptions.
Product discontinuations or reintroductions.

What patents protect PEDVAXHIB?

The current commercial position of PEDVAXHIB is not dependent on a live, high-value patent estate.

Potential historical intellectual-property categories include:

PRP-OMP conjugate composition.
Conjugation chemistry.
Carrier-protein technology.
Stabilizers and excipients.
Manufacturing and purification processes.
Container and delivery systems.

Public product labeling identifies the formulation and manufacturing requirements but does not establish a currently enforceable patent moat around the product. Any residual process know-how may still have commercial value as trade secret information, even after patent expiry.

The most durable protection is operational. A new entrant must meet strict specifications for antigen identity, potency, sterility, purity, stability and lot consistency. Those requirements can delay competition without creating formal market exclusivity.

What licensing deals affect PEDVAXHIB?

No major current licensing transaction is publicly identified as a principal driver of PEDVAXHIB economics. Merck’s ownership and commercialization of the product are the central commercial facts in the public record.

The broader Hib market includes partnerships and joint ventures around combination vaccines. Vaxelis, for example, reflects collaboration between Merck and Sanofi and competes directly with standalone Hib products by embedding Hib antigen in a broader pediatric vaccine.[5]

That competitive structure is important. Merck participates in both sides of the market: PEDVAXHIB as a standalone Hib vaccine and Vaxelis as a combination product. A shift from standalone Hib vaccination to combination vaccination can preserve Merck’s participation in the pediatric vaccine market while reducing the relative importance of PEDVAXHIB.

What litigation and settlement risks affect PEDVAXHIB?

No prominent active patent litigation or Paragraph IV settlement is publicly associated with PEDVAXHIB.

The principal legal and commercial risks are more likely to involve:

Product-liability claims.
Manufacturing deviations.
Regulatory inspections.
Labeling or pharmacovigilance matters.
Procurement disputes.
Supply commitments.
Contract pricing.
Patent disputes involving competing vaccine technologies rather than PEDVAXHIB itself.

Because the product is used in infants, adverse-event allegations can carry disproportionate reputational and legal consequences even when causation is not established. The financial impact would likely arise through liability reserves, insurance costs, regulatory action, or demand disruption rather than loss of patent exclusivity.

What generic-launch risks exist for PEDVAXHIB?

The near-term risk is not a conventional generic launch. The more realistic scenario is gradual substitution by other licensed Hib vaccines.

Base case

PEDVAXHIB remains available as a mature standalone product, with flat or declining unit demand and limited contribution to Merck’s overall vaccine revenue.

Downside case

Combination vaccines capture a larger share of infant immunization, reducing standalone Hib purchases. Lower volume creates manufacturing inefficiency or leads to commercial discontinuation.

Upside case

A supply interruption affecting competing combination or standalone products increases demand for PEDVAXHIB. Its two-dose schedule could also support temporary share gains in markets where providers seek alternatives.

Exit scenario

Merck discontinues or reduces standalone PEDVAXHIB production while maintaining pediatric vaccine participation through combination products. This would be commercially rational if PEDVAXHIB’s revenue and margin contribution fall below the cost of maintaining dedicated supply.

How does PEDVAXHIB compare with Vaxelis financially?

Factor	PEDVAXHIB	Vaxelis
Product type	Standalone Hib vaccine	Combination pediatric vaccine
Injection burden	Requires separate Hib injection	Consolidates multiple antigens
Primary schedule	Two-dose Hib primary series	Typically used in a three-dose combination series
Procurement value	Narrow product category	Broad pediatric immunization purchase
Substitution risk	High from combination products	Lower because it replaces several products at once
Manufacturing complexity	Lower antigen count, but biologically demanding	Higher combination-product complexity
Strategic position for Merck	Mature legacy product	Broader platform product
Growth outlook	Stable to declining	Better positioned for share capture

Vaxelis has a stronger strategic position because it participates in the shift toward combination immunization. PEDVAXHIB remains relevant where standalone Hib vaccination is preferred, but its role is narrower.

What geographic markets matter for PEDVAXHIB?

The United States is the most important publicly documented commercial market for PEDVAXHIB. Its value is tied to the U.S. childhood immunization schedule, federal purchasing, private pediatric practices and managed-care reimbursement.

International opportunity is limited by:

Local Hib vaccine procurement.
National tender systems.
Pricing controls.
Domestic manufacturing preferences.
Different pediatric schedules.
Use of combination vaccines.
Donor-funded immunization programs.

The product’s commercial trajectory is therefore more dependent on U.S. supply and procurement than on global pharmaceutical expansion.

Key Takeaways

PEDVAXHIB is a mature Merck Hib vaccine with a two-dose primary series.
Its main commercial advantage is schedule convenience relative to three-dose primary Hib products.
Combination vaccines, especially Vaxelis and Pentacel, are the principal source of competitive pressure.
Merck does not disclose PEDVAXHIB revenue separately.
Standalone sales are likely mature to declining, although routine vaccination supports recurring demand.
There is no material public Paragraph IV or biosimilar threat.
The product’s original patent estate is not the main commercial barrier.
Manufacturing capability, FDA licensure, procurement access and supply reliability are more important than patent exclusivity.
Merck’s broader vaccine revenue cannot be used to estimate PEDVAXHIB performance.
The most plausible long-term risk is substitution or manufacturing rationalization, not a conventional generic launch.

FAQs

Is PEDVAXHIB still part of the U.S. childhood vaccine schedule?

Yes. CDC guidance includes PEDVAXHIB among the Hib vaccine options for eligible infants and children, subject to age and prior vaccination history.[1]

Is PEDVAXHIB interchangeable with Vaxelis?

Not automatically in every schedule position. The applicable product schedule depends on prior doses, age and the products previously administered. CDC guidance governs catch-up and series completion.

Does PEDVAXHIB have a biosimilar competitor?

No biosimilar competitor has established a commercial market for PEDVAXHIB. Competition comes from separately licensed Hib and combination vaccines.

Why could Merck discontinue PEDVAXHIB even if Hib vaccination remains mandatory?

Standalone demand can decline as providers shift to combination vaccines. If volume falls below efficient manufacturing scale, Merck could preserve pediatric vaccine participation through combination products while reducing standalone production.

Can PEDVAXHIB revenue be modeled from Merck’s vaccine segment?

Not reliably. Merck does not provide product-level PEDVAXHIB revenue, volume, gross margin or contract data. A defensible model would require nonpublic shipment, pricing or procurement information.

References

Centers for Disease Control and Prevention. (2024). Child and adolescent immunization schedule by age. U.S. Department of Health and Human Services. https://www.cdc.gov/vaccines/schedules/
Merck & Co., Inc. (2025). 2024 annual report. https://www.merck.com/annual-reports/
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/
U.S. Food and Drug Administration. (2024). Purple Book: Database of licensed biological products. https://purplebooksearch.fda.gov/
U.S. Food and Drug Administration. (2021). Vaxelis prescribing information. https://www.fda.gov/vaccines-blood-biologics/vaccines/vaxelis

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