Last Updated: May 10, 2026

Amoxicillin; vonoprazan fumarate - Generic Drug Details


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What are the generic sources for amoxicillin; vonoprazan fumarate and what is the scope of freedom to operate?

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.

One supplier is listed for this compound.

Summary for amoxicillin; vonoprazan fumarate
International Patents:103
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 8
DailyMed Link:amoxicillin; vonoprazan fumarate at DailyMed
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.

Recent Clinical Trials for amoxicillin; vonoprazan fumarate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Tanta UniversityPHASE2
Sixth Affiliated Hospital, Sun Yat-sen UniversityPhase 3
The First Affiliated Hospital of Nanchang UniversityPhase 4

See all amoxicillin; vonoprazan fumarate clinical trials

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 ⤷  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
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for amoxicillin; vonoprazan fumarate

Country Patent Number Title Estimated Expiration
South Korea 20110091826 ⤷  Start Trial
Taiwan I358296 ⤷  Start Trial
China 101300229 ⤷  Start Trial
South Korea 20110042334 PHARMACEUTICAL COMPOSITION ⤷  Start Trial
New Zealand 591344 Stabilized pharmaceutical composition comprising a nonpeptidic active agent ⤷  Start Trial
European Patent Office 2327692 ⤷  Start Trial
Ukraine 94424 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Amoxicillin; vonoprazan fumarate Market Analysis and Financial Projection

Last updated: April 24, 2026

Amoxicillin and Vonoprazan Fumarate: Market Dynamics and Financial Trajectory

What is the market structure for amoxicillin?

Amoxicillin is a mature, commoditized antibiotic with a mature global supply base and price sensitivity driven by generic competition and procurement-led contracting. The market dynamic is dominated by:

  • Generic supply concentration in major producing regions and price erosion after patent expiry windows.
  • Formulary placement and tendering that compress margins and shift share based on bid economics rather than differentiated clinical value.
  • Regulatory and quality compliance costs that sustain manufacturer turnover and intermittently stress regional supply chains, but do not structurally reprice the category upward.

Key implication: Amoxicillin typically tracks broader infectious-disease demand, seasonal respiratory cycles, and healthcare spending, with revenue growth driven more by volume and geography mix than by sustained unit price.

What is the market structure for vonoprazan fumarate?

Vonoprazan fumarate is a newer acid-suppression drug positioned in the acid-related gastrointestinal segment (commonly used for GERD and related conditions, and in combination regimens). Its market dynamic is driven by:

  • Reimbursement and guideline adoption that determines how quickly prescribing expands beyond initial uptake.
  • Brand-to-generic and combination competitive switching once exclusivity ends for key formulations and geographies.
  • Payer sensitivity to total regimen cost when vonoprazan is used in multi-drug therapeutic protocols (for example, H. pylori eradication regimens depending on local labeling and practice).

Key implication: Vonoprazan has a growth profile shaped by uptake and switching, but its financial trajectory is exposed to exclusivity cliffs and competitive entry in each market.


How do demand drivers differ between the two assets?

Amoxicillin demand drivers

  • Infection incidence and prescribing patterns across respiratory, ear/nose/throat, dental, and urinary indications.
  • Antibiotic stewardship rules that can constrain broad prescribing growth even as absolute demand remains high.
  • Government and hospital procurement as a primary volume channel, where purchasing decisions follow cost and availability.

Vonoprazan demand drivers

  • GERD and related disease burden with adoption tied to symptom control and persistence.
  • Combination/regimen use that can create “bundle” stickiness with specific protocols used by clinicians and health systems.
  • Guideline updates and payer policies that can either accelerate or delay penetration.

What does the competitive landscape imply for pricing and margins?

Amoxicillin

Competitive pressure is structurally generic:

  • Multiple equivalent generics drive sustained price compression.
  • Switching barriers are low in many markets because clinical equivalence and procurement policies dominate.
  • Manufacturing scale and supply reliability are the principal differentiators.

Margin profile: typically thin relative to specialty pharma, with profitability influenced by production efficiency and contract mix rather than premium pricing.

Vonoprazan fumarate

Competitive pressure depends on:

  • Exclusivity windows for the originator brand and approved indications/formulations in each jurisdiction.
  • Class competition from other acid suppressants (proton pump inhibitors and potassium-competitive acid blockers depending on geography).
  • Formulation and regimen positioning in payer decisioning.

Margin profile: higher than mature generics during early brand phases, but exposed to stepped pricing declines after competitive entries and genericization of active and fixed-dose combinations.


What is the financial trajectory likely to look like by phase?

Amoxicillin: mature category trajectory

Amoxicillin’s revenue path generally follows a mature-to-flat to mildly declining pattern in developed markets:

  • Net sales growth: volume and geographic expansion, offset by ongoing unit price erosion.
  • Gross margin: pressured by generic pricing and manufacturing cost inflation.
  • Operating leverage: limited, because portfolio breadth and geographic footprint matter more than incremental R&D monetization.

Vonoprazan fumarate: uptake then exclusivity-driven step-down

Vonoprazan’s revenue path typically follows:

  • Launch-to-growth phase driven by guideline adoption and early prescriber behavior.
  • Mature brand plateau when penetration stabilizes and competitive class pressure limits price.
  • Post-exclusivity decline in markets where generics or competing branded products enter.

Key financial driver: the speed and breadth of competitive entry at the formulation level (API and finished dosage forms) and the depth of payer formularies post-exclusivity.


How do regulatory and safety considerations influence revenue risk?

Amoxicillin

  • Stewardship policies can reduce unnecessary prescribing, dampening volume.
  • Resistance management can shift prescribing guidelines toward narrower or alternative agents in some settings.

Vonoprazan

  • Label expansions or restrictions in key indications can change prescribing velocity.
  • Safety monitoring and comparative effectiveness narratives can influence payer coverage decisions.

What are the major channel and geography levers?

Amoxicillin

  • Government and hospital channels in higher-volume markets.
  • Tender-driven distribution in Europe and parts of Asia.
  • Commodity contracting in North America and multi-source supply contexts.

Vonoprazan fumarate

  • Specialty and GI-focused prescribing that impacts early uptake.
  • Hospital formulary dynamics that can produce step-function changes in share.
  • Reimbursement coverage that can limit or accelerate access to combination regimens.

What investment or R&D implications follow from the two trajectories?

Amoxicillin

R&D and investment economics usually hinge on:

  • Manufacturing differentiation (cost, yields, supply reliability) rather than new clinical value.
  • Portfolio adjacency (combination products, stable dosage improvements) that can extend revenue through lifecycle management.

Vonoprazan fumarate

The financial story depends on:

  • Indication breadth and how well the product is placed in guideline-recommended regimens.
  • Lifecycle extension strategy (new formulations, label expansions, fixed-dose combinations where allowed by evidence).
  • Timing of competitive entry and payer shift behavior.

Key Takeaways

  • Amoxicillin is a commoditized antibiotic market where revenue growth is primarily volume-led and pricing is pressured by generic competition and tender contracting.
  • Vonoprazan fumarate is a newer GI acid-suppression asset whose financial trajectory is driven by uptake dynamics, guideline adoption, and exclusivity-by-market step-down after competitive entry.
  • The pricing and margin structure differs fundamentally: amoxicillin is procurement-led and price-sensitive; vonoprazan is adoption- and reimbursement-led with clearer phase transitions tied to exclusivity and formulary access.

FAQs

1) Is amoxicillin’s growth mainly tied to new drug launches?

No. Growth is typically tied to volume and geography mix because generics dominate unit economics.

2) What most determines vonoprazan revenue trajectory?

Guideline adoption, payer formulary coverage, and the timing and breadth of competitive entry after exclusivity.

3) Which asset is more exposed to tendering and procurement pricing pressure?

Amoxicillin.

4) Which asset is more exposed to payer and guideline adoption swings?

Vonoprazan fumarate.

5) Which has the more predictable lifecycle pattern?

Amoxicillin has a predictable mature-commodity pattern; vonoprazan shows more phase-based step effects tied to uptake and exclusivity cliffs.


References

[1] U.S. Food and Drug Administration. (n.d.). Drug approval reports and label information for amoxicillin and related products. FDA. https://www.fda.gov/drugs
[2] European Medicines Agency. (n.d.). EPARs and product information for amoxicillin and related medicines. EMA. https://www.ema.europa.eu
[3] World Health Organization. (n.d.). Antibiotic stewardship and global antibiotic resistance guidance. WHO. https://www.who.int/health-topics/antimicrobial-resistance
[4] U.S. Food and Drug Administration. (n.d.). Drug approval and safety information resources. FDA. https://www.fda.gov/drugs
[5] European Medicines Agency. (n.d.). Overview of gastrointestinal medicines and mechanisms of action in marketing authorization materials. EMA. https://www.ema.europa.eu

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