Last Updated: June 23, 2026

amoxicillin; vonoprazan fumarate - Profile


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What are the generic sources for amoxicillin; vonoprazan fumarate and what is the scope of patent protection?

Amoxicillin; vonoprazan fumarate is the generic ingredient in one branded drug marketed by Phathom and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amoxicillin; vonoprazan fumarate has one hundred and three patent family members in forty-three countries.

Summary for amoxicillin; vonoprazan fumarate
International Patents:103
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for amoxicillin; vonoprazan fumarate
Generic Entry Date for amoxicillin; vonoprazan fumarate*:
Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

Dosage:

CAPSULE, TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for amoxicillin; vonoprazan fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Phathom VOQUEZNA DUAL PAK amoxicillin; vonoprazan fumarate CAPSULE, TABLET;ORAL 215153-001 May 3, 2022 RX Yes Yes 9,186,411 ⤷  Start Trial Y ⤷  Start Trial
Phathom VOQUEZNA DUAL PAK amoxicillin; vonoprazan fumarate CAPSULE, TABLET;ORAL 215153-001 May 3, 2022 RX Yes Yes 7,977,488 ⤷  Start Trial Y ⤷  Start Trial
Phathom VOQUEZNA DUAL PAK amoxicillin; vonoprazan fumarate CAPSULE, TABLET;ORAL 215153-001 May 3, 2022 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Phathom VOQUEZNA DUAL PAK amoxicillin; vonoprazan fumarate CAPSULE, TABLET;ORAL 215153-001 May 3, 2022 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Last updated: April 24, 2026

Amoxicillin and Vonoprazan Fumarate: Investment Scenario and Fundamentals Analysis

What is the commercial setup for these drugs?

Amoxicillin is a generic, off-patent antibiotic across most major markets. Commercial value depends on volume, mix (capsules vs tablets vs suspensions), price discipline, and contracting rather than patent-linked exclusivity.

Vonoprazan fumarate (a potassium-competitive acid blocker, P-CAB) is a branded, patent-relevant asset in markets where exclusivity still applies. Commercial value depends on assumption-driven adoption in H. pylori and erosive reflux workflows, guideline fit, payer status, and competitive dynamics vs PPIs and other acid blockers.

In short: amoxicillin is a scale-and-margin product; vonoprazan is an innovation-adoption product.


How do key demand drivers differ?

Amoxicillin: demand is driven by infection incidence and contracting

Demand is shaped by:

  • Community-acquired respiratory infections and otitis media workflows that drive outpatient prescribing
  • Stewardship and guideline-driven restriction, which constrains growth in higher-resistance regimes
  • Generic substitution that compresses price and shifts value toward procurement scale

Core investment implication: margins track tender/contract pricing and manufacturing cost position, not long-hold pricing power.

Vonoprazan: demand is driven by acid-related disease pathways

Vonoprazan is positioned around:

  • H. pylori eradication regimens where acid suppression improves antibiotic efficacy
  • Gastroesophageal reflux disease (GERD) and erosive disease endpoints
  • Refractory symptom pathways where rapid and sustained acid suppression affects clinician choice

Core investment implication: unit growth depends on conversion of clinicians from PPIs and persistence of payer coverage for newer regimens.


Where do the fundamental economics sit?

Amoxicillin fundamentals (investor lens)

  • Pricing: structurally downward due to generic competition
  • Cost structure: manufacturing reliability, yield, and API sourcing dominate
  • Risk: antibiotic class risks (market withdrawals in specific lots, regulatory actions) and stewardship-driven utilization shifts
  • Upside: only from volume gains in emerging markets, new formulations, and contract wins

Because amoxicillin is generic, valuation tends to follow:

  • Capacity utilization
  • Net price trend vs input costs
  • Working capital discipline
  • Regulatory continuity (quality system performance)

Vonoprazan fundamentals (investor lens)

For a P-CAB in acid suppression:

  • Revenue is regimen-based (often as part of combination therapies)
  • Gross margin depends on formulation and supply chain maturity
  • Commercial risk is adoption and formulary access
  • Competitive risk is substitution by PPIs or other acid blockers

Vonoprazan’s fundamental revenue trajectory is therefore linked to:

  • Guideline inclusion and switching rate from PPIs
  • Reimbursement durability
  • Clinical differentiation narrative in H. pylori and erosive GERD settings

What does the competitive landscape imply for returns?

Amoxicillin: competition is generic and cost-based

Main competitors are:

  • Other generic amoxicillin manufacturers
  • Multisource formulations (tablets, capsules, dispersible forms)
  • Combination products (amoxicillin-clavulanate) that can shift share

Return drivers:

  • Lowest delivered cost to wholesalers/health systems
  • Consistent quality records
  • Fast regulatory/CMC maintenance

Investment takeaway: amoxicillin offers defensive cash flow potential for scaled manufacturers but limited patent-like upside.

Vonoprazan: competition is class-based

Key competitive set:

  • PPIs (omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole)
  • Other acid suppression entrants (within the P-CAB space, depending on market)
  • Managed care formulary restrictions

Return drivers:

  • Clinical comfort in H. pylori therapy compliance settings
  • Payer willingness to cover a P-CAB vs cheaper PPIs
  • Evidence-based switching in erosive GERD workflows

Investment takeaway: vonoprazan supports a higher upside distribution profile than amoxicillin, but returns hinge on commercialization execution rather than cost-only scale.


What are the prescribing and clinical evidence anchors?

Amoxicillin

Amoxicillin is a standard antibiotic used widely in clinical practice for susceptible bacterial infections. Its ongoing use is supported by long-established efficacy and spectrum, with selection governed by local resistance patterns and stewardship.

Primary clinical anchor: standard-of-care antibiotic status across many outpatient infection types, subject to susceptibility and guideline frameworks.

Vonoprazan

Vonoprazan is used as a strong acid suppression agent and is incorporated in H. pylori eradication regimens in jurisdictions where it is approved and reimbursed. The class effect targets improved eradication outcomes through potent, sustained acid suppression.

Primary clinical anchor: P-CAB mechanism and clinical regimen adoption in acid-mediated disease workflows.


How does IP and regulatory posture affect investment timing?

This analysis treats the investment setup as two distinct profiles:

Amoxicillin

  • Patent exclusivity is largely irrelevant for most investors because the market is generic-dominated.
  • The relevant “IP” becomes operational: process capability, quality systems, regulatory compliance, and cost leadership.

Vonoprazan fumarate

  • IP and regulatory exclusivity matter because the drug is not uniformly generic across markets.
  • Valuation sensitivity concentrates around:
    • Remaining exclusivity windows
    • Regulatory milestones by geography
    • New indication expansions and line extensions if any

What is the plausible investment scenario matrix?

Scenario A: Scaled manufacturer exposure to amoxicillin

Thesis: secure share through contracts and cost discipline.
Strength: stable underlying demand for common infections.
Risks: price compression, stewardship-driven prescribing changes, and quality/regulatory interruptions.

Key indicators to track

  • Net selling price trend and tender outcomes
  • Capacity utilization and COGS per unit
  • Complaint rates, batch failures, and regulatory actions
  • Mix shift to higher-value formulations (if available)

Scenario B: Commercialization and formulary execution around vonoprazan

Thesis: adoption via regimen-based use where P-CAB’s acid suppression translates into meaningful clinical outcomes and clinician preference.
Strength: innovation-like commercial potential vs generic antibiotics.
Risks: payer pushback to lower-cost PPIs and slow conversion of clinician workflow.

Key indicators to track

  • Share shifts in H. pylori and erosive GERD pathways
  • Claims data trends (TRx and PDC)
  • Formulary access and rebate pressure
  • Competitive entry patterns and price index movements

Fundamentals comparison: amoxicillin vs vonoprazan fumarate

Dimension Amoxicillin Vonoprazan fumarate
Market structure Generic, multi-source Branded/less commoditized where exclusive
Primary value driver Cost leadership and contracts Adoption, regimen inclusion, payer access
Pricing power Limited by competition Moderate and policy-dependent
Demand stability Medium to stable by infection incidence Higher variability by prescribing and coverage
Key risks Price compression, resistance patterns, stewardship Payer restrictions, class competition vs PPIs

What do investors actually underwrite?

Underwriting for amoxicillin

  • Supply reliability and unit cost discipline
  • Downstream contracting (wholesale and health systems)
  • Regulatory compliance and batch quality performance
  • Portfolio adjacency (if the platform includes other beta-lactams, this can stabilize volumes and utilization)

A practical return profile: steady operating cash flow with limited upside, unless the firm expands capacity or secures advantageous contract structures.

Underwriting for vonoprazan

  • Adoption curve in the target regimens
  • Formulary penetration and persistence of reimbursement
  • Therapeutic switching from PPIs
  • Competitive intensity within acid suppression class

A practical return profile: higher valuation sensitivity to commercial execution and payer policy.


What is the investment decision framework (actionable)?

Use a two-track approach:

1) Amoxicillin track (operational investing)

  • Buy/allocate to lowest-cost, highest-reliability manufacturing and distribution positions
  • Weight KPIs toward gross margin durability, utilization, and regulatory standing

2) Vonoprazan track (commercial investing)

  • Buy/allocate to companies with evidence of formularies and regimen traction
  • Weight KPIs toward claims-based growth, net price retention after rebates, and competitive share

Key Takeaways

  • Amoxicillin is a generic, scale-and-margin antibiotic where value comes from manufacturing cost position and contracting discipline.
  • Vonoprazan fumarate is a patent-relevant P-CAB asset where value comes from adoption in H. pylori and erosive GERD regimens, plus payer access and formulary durability.
  • Best-fit investment strategies differ: operational underwriting for amoxicillin and commercial underwriting for vonoprazan.

FAQs

1) Is amoxicillin an investment where patents matter?

No. The market is predominantly generic; returns depend on operations, contracting, and cost structure rather than exclusivity.

2) What is the main commercial bottleneck for vonoprazan?

Formulary access and payer reimbursement versus cheaper PPIs, which governs adoption pace and net pricing.

3) Which drug is more exposed to price compression?

Amoxicillin, due to multi-source generic competition.

4) What KPIs best proxy vonoprazan fundamentals?

Prescription or claims-based unit growth, net price after rebates, and share shifts in H. pylori and erosive GERD treatment settings.

5) Which risk dominates for amoxicillin manufacturing platforms?

Quality system performance and batch reliability, because supply disruptions can quickly translate into lost contract coverage and regulatory exposure.


References

[1] FDA. Amoxicillin (drug label information and prescribing resources). U.S. Food and Drug Administration. https://www.fda.gov/
[2] FDA. Vonoprazan fumarate (regulatory information and prescribing resources, where applicable). U.S. Food and Drug Administration. https://www.fda.gov/
[3] ACG Clinical Guidelines. Management of Helicobacter pylori infection and acid-related disorders (guideline framework for regimen selection). American College of Gastroenterology. https://gi.org/
[4] Maastricht VI/Florence Consensus Report. Helicobacter pylori management consensus framework relevant to eradication regimen use. https://gut.bmj.com/

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