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Last Updated: December 22, 2024

AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE - Generic Drug Details


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

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

One supplier is listed for this compound.

Summary for AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE
International Patents:103
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 2
DailyMed Link:AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE
Generic Entry Date for AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW
Dosage:
CAPSULE, TABLET, 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; CLARITHROMYCIN; VONOPRAZAN FUMARATE

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

SponsorPhase
The First Affiliated Hospital with Nanjing Medical UniversityPhase 4
Maternity and Child Care Health Center of DezhouPhase 4
The People's Hospital of GuangraoPhase 4

See all AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE clinical trials

US Patents and Regulatory Information for AMOXICILLIN; CLARITHROMYCIN; 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 TRIPLE PAK amoxicillin; clarithromycin; vonoprazan fumarate CAPSULE, TABLET, TABLET;ORAL 215152-001 May 3, 2022 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Phathom VOQUEZNA TRIPLE PAK amoxicillin; clarithromycin; vonoprazan fumarate CAPSULE, TABLET, TABLET;ORAL 215152-001 May 3, 2022 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Phathom VOQUEZNA TRIPLE PAK amoxicillin; clarithromycin; vonoprazan fumarate CAPSULE, TABLET, TABLET;ORAL 215152-001 May 3, 2022 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Phathom VOQUEZNA TRIPLE PAK amoxicillin; clarithromycin; vonoprazan fumarate CAPSULE, TABLET, TABLET;ORAL 215152-001 May 3, 2022 RX Yes Yes ⤷  Subscribe ⤷  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; CLARITHROMYCIN; 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
>Country >Patent Number >Title >Estimated Expiration

AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amoxicillin, Clarithromycin, and Vonoprazan Fumarate

Introduction

The pharmaceutical market is witnessing significant growth driven by increasing healthcare expenditures, advancements in medical technologies, and a rising prevalence of infectious and gastrointestinal diseases. This article delves into the market dynamics and financial trajectory of three key drugs: amoxicillin, clarithromycin, and vonoprazan fumarate.

Amoxicillin Market Dynamics

Market Size and Growth

The amoxicillin market has shown steady growth in recent years. In 2023, the market size was valued at $4.58 billion and is expected to reach $4.74 billion in 2024, with a compound annual growth rate (CAGR) of 3.4%. By 2028, the market is projected to grow to $5.44 billion at a CAGR of 3.5%[1][4].

Drivers of Growth

Several factors are driving the growth of the amoxicillin market:

  • Increasing Prevalence of Infectious Diseases: The rise in bacterial infections, lower respiratory tract infections, and skin infections is fueling the demand for amoxicillin.
  • Healthcare Expenditure: Increased healthcare spending globally ensures wider accessibility and availability of amoxicillin, leading to higher prescription rates and improved patient outcomes.
  • Combination Therapies: The focus on combination therapies, such as pairing amoxicillin with other antibiotics or with vonoprazan, is enhancing treatment efficacy and driving market growth[1][4].

Trends and Innovations

Key trends in the amoxicillin market include:

  • Generic Amoxicillin Demand: There is a surge in demand for generic versions of amoxicillin, which is more affordable and accessible.
  • Probiotics and Immunotherapy: Interest in probiotics and immunotherapy is also influencing the market, as these approaches are being explored to complement antibiotic treatments[1][4].

Clarithromycin Market Dynamics

Integration with Other Therapies

Clarithromycin, often used in combination with amoxicillin and vonoprazan, benefits from the same market drivers as amoxicillin. The approval of combination packs like VOQUEZNA TRIPLE PAK (vonoprazan, amoxicillin, clarithromycin) and VOQUEZNA DUAL PAK (vonoprazan, amoxicillin) by the FDA in May 2022 has boosted the market for clarithromycin[1][3].

Market Impact

The integration of clarithromycin into combination therapies enhances its market presence by offering comprehensive treatment regimens for infections such as Helicobacter pylori (H. pylori).

Vonoprazan Fumarate Market Dynamics

Market Size and Growth

The vonoprazan fumarate API market is experiencing rapid growth, with substantial expansion expected from 2023 to 2031. The market is driven by several key factors:

  • Increasing Healthcare Expenditure: Growing healthcare spending, especially in emerging economies, supports the development and accessibility of vonoprazan fumarate[5].
  • Regulatory Approvals: Favorable regulatory approvals from health authorities like the FDA and EMA validate the safety and efficacy of vonoprazan fumarate, promoting its adoption[5].

Drivers of Growth

Several drivers are contributing to the growth of the vonoprazan fumarate market:

  • 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].
  • Strategic Collaborations: 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 demand for effective medications like vonoprazan fumarate[5].

Market Expansion

Emerging economies in Asia-Pacific, Latin America, and the Middle East present significant growth opportunities for the vonoprazan fumarate API market due to improving healthcare infrastructure and rising disposable incomes[5].

Financial Trajectory

Amoxicillin

The financial trajectory for amoxicillin is positive, with steady growth projected over the next few years. The market is expected to grow from $4.58 billion in 2023 to $5.44 billion by 2028, driven by increasing healthcare expenditure and the rising prevalence of infectious diseases[1][4].

Clarithromycin

While specific financial data for clarithromycin is not isolated, its integration into combination therapies with amoxicillin and vonoprazan indicates a strong financial outlook. The approval and successful marketing of these combination packs are likely to contribute significantly to the revenue of companies involved, such as Phathom Pharmaceuticals[1][3].

Vonoprazan Fumarate

The vonoprazan fumarate API market is poised for significant growth, with substantial expansion expected from 2023 to 2031. The market benefits from increasing healthcare expenditure, favorable regulatory approvals, and high efficacy, making it a lucrative segment within the pharmaceutical industry[5].

Regional Market Performance

Amoxicillin

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].

Vonoprazan Fumarate

Emerging economies in the Asia-Pacific, Latin America, and the Middle East are key growth areas for the vonoprazan fumarate API market due to improving healthcare infrastructure and rising disposable incomes[5].

Key Trends and Innovations

Combination Therapies

The focus on combination therapies, such as the VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK, is a significant trend. These combinations enhance treatment efficacy and patient compliance, driving market growth for all three drugs[1][3].

Regulatory Approvals

Regulatory approvals play a crucial role in the market dynamics of these drugs. For example, the FDA approval of vonoprazan-based combination packs has significantly boosted their market presence[1][3].

Technological Advancements

Advancements in healthcare facilities and technological improvements in manufacturing and distribution are also driving the growth of these markets. Enhanced manufacturing capabilities and global supply chains facilitate the production and distribution of these drugs[1][5].

Conclusion

The markets for amoxicillin, clarithromycin, and vonoprazan fumarate are experiencing robust growth driven by increasing healthcare expenditure, rising prevalence of infectious and gastrointestinal diseases, and favorable regulatory approvals. The focus on combination therapies and technological advancements further enhances the market dynamics of these drugs.

Key Takeaways

  • The amoxicillin market is expected to grow to $5.44 billion by 2028, driven by increasing healthcare expenditure and the rising prevalence of infectious diseases.
  • Clarithromycin benefits from its integration into combination therapies with amoxicillin and vonoprazan.
  • The vonoprazan fumarate API market is poised for significant growth from 2023 to 2031, driven by high efficacy, favorable regulatory approvals, and increasing healthcare expenditure.
  • Emerging economies present significant growth opportunities for these markets.
  • Combination therapies and technological advancements are key trends driving market growth.

FAQs

Q: What is the projected growth rate of the amoxicillin market from 2023 to 2028?

A: The amoxicillin market is expected to grow at a compound annual growth rate (CAGR) of 3.5% from 2023 to 2028[1][4].

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

A: Key drivers include increasing healthcare expenditure, favorable regulatory approvals, high efficacy, and strategic collaborations[5].

Q: Which region is expected to be the fastest-growing for the amoxicillin market?

A: The Asia-Pacific region is expected to be the fastest-growing region for the amoxicillin market in the forecast period[1].

Q: What is the significance of combination therapies in the market dynamics of these drugs?

A: Combination therapies, such as VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK, enhance treatment efficacy and patient compliance, driving market growth for all three drugs[1][3].

Q: How does increasing healthcare expenditure impact the market for these drugs?

A: Increasing healthcare expenditure ensures wider accessibility and availability of these drugs, leading to higher prescription rates and improved patient outcomes[1][5].

Sources

  1. GlobeNewswire: Amoxicillin Market Research Report 2024: Combination Therapies and Immunotherapy Trends Shaping Future Landscape - Global Long-term Forecast to 2028 and 2033.
  2. Market Research Intellect: Vonoprazan Fumarate API Market Size, Scope And Forecast Report.
  3. Phathom Pharmaceuticals: United States Securities and Exchange Commission - Form 10-K.
  4. GII Research: Amoxicillin Global Market Report 2024.
  5. Verified Market Research: Vonoprazan Fumarate API Market Size & Forecast.

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