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Last Updated: December 22, 2024

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: 7
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
Sixth Affiliated Hospital, Sun Yat-sen UniversityPhase 3
The First Affiliated Hospital of Nanchang UniversityPhase 4
First People's Hospital of FoshanPhase 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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Phathom VOQUEZNA DUAL PAK amoxicillin; vonoprazan fumarate CAPSULE, TABLET;ORAL 215153-001 May 3, 2022 RX Yes Yes 9,186,411 ⤷  Subscribe Y ⤷  Subscribe
Phathom VOQUEZNA DUAL PAK amoxicillin; vonoprazan fumarate CAPSULE, TABLET;ORAL 215153-001 May 3, 2022 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Phathom VOQUEZNA DUAL PAK amoxicillin; vonoprazan fumarate CAPSULE, TABLET;ORAL 215153-001 May 3, 2022 RX Yes Yes 7,977,488 ⤷  Subscribe Y ⤷  Subscribe
>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
Cyprus 1111922 ⤷  Subscribe
Morocco 32556 تركيب صيدلاني ⤷  Subscribe
European Patent Office 2564833 Composition pharmaceutique stabilisée à la lumière (Photostabilized pharmaceutical composition) ⤷  Subscribe
Brazil PI0916689 composição farmacêutica estabilizada, preparação sólida, e, métodos para estabilizar uma composição farmacêutica, e para estabilizar uma preparação sólida. ⤷  Subscribe
Taiwan I358296 ⤷  Subscribe
Japan 5593363 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Amoxicillin; vonoprazan fumarate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amoxicillin and Vonoprazan Fumarate

Introduction to Amoxicillin and Vonoprazan Fumarate

Amoxicillin and vonoprazan fumarate are two significant pharmaceuticals with distinct roles in the treatment of various medical conditions. Amoxicillin is a widely used antibiotic, while vonoprazan fumarate is a novel potassium-competitive acid blocker (PCAB) used primarily for acid-related disorders.

Amoxicillin Market Overview

Current Market Size and Growth

The amoxicillin market has been growing steadily, with a market size of $4.58 billion in 2023 and an expected increase to $4.74 billion in 2024, reflecting a compound annual growth rate (CAGR) of 3.4%[1].

Forecasted Growth

By 2028, the amoxicillin market is projected to reach $5.44 billion, maintaining a CAGR of 3.5%. This growth is driven by factors such as the increasing incidence of impaired renal function, higher prevalence of lower respiratory infections, and rising cases of skin infections[1].

Key Drivers

  • Increasing Healthcare Expenditure: Higher healthcare spending ensures wider accessibility and availability of amoxicillin, leading to higher prescription rates and improved patient outcomes[1].
  • Rising Prevalence of Infectious Diseases: Global travel, antimicrobial resistance, and climate change are contributing to the increased incidence of infectious diseases, driving the demand for amoxicillin[1].
  • Advancements in Healthcare Facilities: Improved healthcare infrastructure and technological advancements support the production and distribution of amoxicillin[1].

Market Trends

  • Generic Amoxicillin Demand: There is a surge in demand for generic versions of amoxicillin, which is expected to continue in the forecast period[1].
  • Combination Therapies: The focus on combination therapies, such as the combination of amoxicillin with vonoprazan and clarithromycin for treating Helicobacter pylori infections, is a significant trend[1].

Vonoprazan Fumarate Market Overview

Current Market Dynamics

The vonoprazan fumarate API market has experienced rapid growth in recent years and is expected to continue this trend from 2023 to 2031. The market is positioned for significant development, driven by positive market dynamics and sustained expansion[2][5].

Forecasted Growth

The vonoprazan fumarate API market is growing at a moderate pace with substantial growth rates. It is estimated to grow significantly during the forecast period of 2024 to 2031, driven by factors such as increasing healthcare expenditure, favorable regulatory approvals, and the expanding global pharmaceutical industry[5].

Key Drivers

  • Increasing Healthcare Expenditure: Growing healthcare spending, particularly in emerging economies, supports the development and accessibility of advanced treatments like vonoprazan fumarate[5].
  • Favorable Regulatory Approvals: Approvals from health authorities such as the FDA and EMA validate the safety and efficacy of vonoprazan fumarate, promoting its adoption in clinical practice[5].
  • High Efficacy and Patient Compliance: Vonoprazan fumarate offers higher efficacy and better patient compliance compared to traditional proton pump inhibitors (PPIs), making it a preferred choice for treating acid-related disorders[5].

Market Trends

  • Strategic Collaborations and Partnerships: Collaborations between pharmaceutical companies, research institutions, and healthcare providers enhance the development and commercialization of vonoprazan fumarate API[5].
  • Rising Awareness and Diagnosis: Increasing awareness about gastrointestinal diseases leads to more diagnoses and treatments, driving the demand for effective medications like vonoprazan fumarate[5].

Financial Trajectory for Amoxicillin

Pricing Trends

The global prices of amoxicillin trihydrate are anticipated to decline in January 2024 due to reduced demand, enhanced manufacturing activity, and increased supply. However, there is an expectation of a price uptick in the upcoming months driven by a resurgence in demand from the healthcare and pharmaceutical sectors[4].

Regional Performance

North America was the largest region in the amoxicillin market in 2023, while the Asia-Pacific region is expected to be the fastest-growing region in the forecast period[1].

Economic Impact

Economic instability, such as the potential for a brief and mild recession in the US in 2024, and challenges in the Eurozone, can impact healthcare spending and demand for amoxicillin. However, the overall growth trajectory remains positive due to the increasing prevalence of infectious diseases and enhanced healthcare expenditure[1][4].

Financial Trajectory for Vonoprazan Fumarate

Pricing and Revenue

The vonoprazan fumarate API market is expected to see significant revenue growth from 2023 to 2031. The market is driven by the high efficacy and patient compliance of vonoprazan fumarate, as well as strategic collaborations and partnerships that facilitate its commercialization[5].

Market Penetration

Phathom Pharmaceuticals, for example, has received FDA approval for VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK, which include vonoprazan, amoxicillin, and clarithromycin for treating Helicobacter pylori infections. This marks a significant milestone in the market penetration of vonoprazan fumarate[1].

Financial Projections

Phathom Pharmaceuticals believes that their existing cash, cash equivalents, and other anticipated capital will be sufficient to fund operations through the end of 2026. The company has a term loan of $300 million, with tranches available based on the achievement of specified revenue milestones[3].

Challenges and Opportunities

Supply Chain Disruptions

Both markets face challenges from supply chain disruptions caused by geopolitical tensions, pandemics, and natural disasters. Ensuring a stable supply chain is critical for market stability and growth[5].

Market Penetration Challenges

Vonoprazan fumarate faces challenges in penetrating new markets and gaining acceptance among healthcare providers and patients. Significant marketing and educational efforts are required to demonstrate its advantages over existing treatments[5].

Economic Constraints

Economic instability and financial constraints in certain regions can impact healthcare spending and access to advanced treatments like vonoprazan fumarate. Budget limitations in healthcare systems can restrict the adoption of new and expensive medications[5].

Key Takeaways

  • Amoxicillin Market Growth: The amoxicillin market is expected to grow steadily, driven by increasing healthcare expenditure and the rising prevalence of infectious diseases.
  • Vonoprazan Fumarate Growth: The vonoprazan fumarate API market is poised for significant growth, driven by favorable regulatory approvals, high efficacy, and strategic collaborations.
  • Pricing Trends: Amoxicillin prices are expected to decline temporarily due to increased supply and reduced demand, while vonoprazan fumarate prices are expected to remain stable due to its high demand and efficacy.
  • Regional Performance: North America and the Asia-Pacific region are key markets for both amoxicillin and vonoprazan fumarate.
  • Challenges and Opportunities: Both markets face challenges from supply chain disruptions and economic constraints, but also present opportunities through strategic collaborations and increasing awareness of gastrointestinal diseases.

FAQs

Q: What is the current market size of the amoxicillin market?

The current market size of the amoxicillin market is $4.58 billion in 2023, expected to grow to $4.74 billion in 2024[1].

Q: What are the key drivers of the vonoprazan fumarate API market?

Key drivers include increasing healthcare expenditure, favorable regulatory approvals, high efficacy and patient compliance, and strategic collaborations and partnerships[5].

Q: How is the pricing of amoxicillin trihydrate expected to change in 2024?

The global prices of amoxicillin trihydrate are anticipated to decline in January 2024 due to reduced demand and increased supply, but may see an uptick in the upcoming months[4].

Q: What are the challenges faced by the vonoprazan fumarate API market in terms of market penetration?

The market faces challenges in penetrating new markets and gaining acceptance among healthcare providers and patients, requiring significant marketing and educational efforts[5].

Q: How does economic instability impact the demand for amoxicillin and vonoprazan fumarate?

Economic instability can reduce healthcare spending and demand for these medications, but the overall growth trajectory remains positive due to the increasing prevalence of infectious diseases and enhanced healthcare expenditure[1][4].

Sources

  1. GlobeNewswire: Amoxicillin Market Research Report 2024.
  2. MarketResearchIntellect: Vonoprazan Fumarate API Market Size, Scope And Forecast Report.
  3. Phathom Pharmaceuticals: CORPORATE OVERVIEW.
  4. ChemAnalyst: Global Amoxicillin Trihydrate Prices Set to Decline in January 2024.
  5. Verified Market Research: Vonoprazan Fumarate API Market Size & Forecast.

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