Amoxicillin; clavulanate potassium - Generic Drug Details

What are the generic drug sources for amoxicillin; clavulanate potassium and what is the scope of freedom to operate?

Amoxicillin; clavulanate potassium is the generic ingredient in nine branded drugs marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Cipla, Deva Holding As, Hikma Pharms, Micro Labs, Micro Labs Ltd India, Sandoz, Sandoz Inc, Sun Pharm Inds Ltd, Teva, Us Antibiotics, Chartwell Rx, Apotex Inc, and Teva Pharms Usa, and is included in forty-nine NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-nine suppliers are listed for this compound.

Summary for amoxicillin; clavulanate potassium

US Patents:	0
Tradenames:	9
Applicants:	15
NDAs:	49
Finished Product Suppliers / Packagers:	39
Raw Ingredient (Bulk) Api Vendors:	16
Clinical Trials:	18
Patent Applications:	1,492
DailyMed Link:	amoxicillin; clavulanate potassium at DailyMed

Recent Clinical Trials for amoxicillin; clavulanate potassium

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

Sponsor	Phase
Second Affiliated Hospital of Wenzhou Medical University	N/A
Alphacait, LLC	Phase 2
Haining Health-Coming Biotech Co., Ltd.	Phase 2

See all amoxicillin; clavulanate potassium clinical trials

Pharmacology for amoxicillin; clavulanate potassium

Drug Class	Penicillin-class Antibacterial beta Lactamase Inhibitor
Mechanism of Action	beta Lactamase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for amoxicillin; clavulanate potassium

J01CA	Penicillins with extended spectrum
J01C	BETA-LACTAM ANTIBACTERIALS, PENICILLINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for AMOXICILLIN; CLAVULANATE POTASSIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AUGMENTIN XR	Extended-release Tablets	amoxicillin; clavulanate potassium	1000 mg/62.5 mg	050785	1	2009-01-21

US Patents and Regulatory Information for amoxicillin; clavulanate potassium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Micro Labs Ltd India	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	205187-001	May 21, 2021	AB	RX	No	No
Teva Pharms Usa	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	TABLET;ORAL	065096-001	Oct 29, 2002	AB	RX	No	No
Micro Labs	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	217805-001	Dec 8, 2023	AB	RX	No	No
Aurobindo Pharma Ltd	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	201090-002	Dec 20, 2011	AB	RX	No	No
Sandoz Inc	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	065358-001	Aug 13, 2007	AB	RX	No	No
Hikma Pharms	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	065373-001	Nov 9, 2007	AB	RX	No	No
Us Antibiotics	AUGMENTIN '400'	amoxicillin; clavulanate potassium	TABLET, CHEWABLE;ORAL	050726-002	May 31, 1996		DISCN	Yes	No

Expired US Patents for amoxicillin; clavulanate potassium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002

Amoxicillin; clavulanate potassium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amoxicillin and Clavulanate Potassium

Introduction

Amoxicillin and clavulanate potassium, a combination antibiotic, has been a cornerstone in the treatment of bacterial infections for decades. This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of this essential pharmaceutical product.

Market Overview

The global market for amoxicillin and clavulanate potassium is poised for significant growth from 2023 to 2031. This upward trajectory is driven by several key factors, including the increasing prevalence of antibiotic-resistant bacterial infections and the growing demand for effective combination therapies[1][3][5].

Market Size and Growth Projections

As of 2023, the amoxicillin and clavulanate potassium market has already reached substantial value, and it is anticipated to continue expanding. By 2031, the market is expected to achieve a notable increase in value, reflecting a strong growth rate during the forecast period[1].

Drivers of Market Growth

Antibiotic Resistance Concerns

The escalating concerns over antibiotic resistance worldwide are a major driver of the market. As bacteria develop resistance to commonly used antibiotics, the demand for potent β-lactamase inhibitors like clavulanate potassium rises, aiding in the restoration of antibiotic efficacy and combating antimicrobial resistance[3][5].

Enhanced Antibiotic Formulations

Pharmaceutical companies are focusing on developing advanced antibiotic formulations that incorporate clavulanate potassium. This combination enhances the spectrum of activity against β-lactamase-producing bacteria, prolonging the effectiveness of antibiotics and addressing unmet medical needs[3][5].

Clinical Efficacy and Safety Profiles

The clinical efficacy and safety profiles of amoxicillin and clavulanate potassium are well-established. The combination is well-absorbed from the gastrointestinal tract, and its pharmacokinetics are minimally affected by food intake. This makes it a reliable and effective treatment option for various bacterial infections[4].

Market Segmentation

By Type

The global clavulanate potassium market is segmented into oral and injection types. The oral type dominates the market, holding the largest share and expected to exhibit the highest Compound Annual Growth Rate (CAGR) during the forecast period. The injection type, though smaller, is also forecasted to grow at a significant CAGR[3].

By Application

The market is categorized by application into hospital pharmacy, retail pharmacy, and online pharmacy segments. Hospital pharmacy dominates the market, with the highest CAGR expected during the forecast period. Retail pharmacy is the second-largest segment, also anticipated to grow at a notable rate[3].

Regional Analysis

North America

North America holds a significant market share, driven by the high incidence of antibiotic-resistant bacterial infections, widespread use of combination therapies, and well-established healthcare infrastructure. The United States and Canada are major contributors to market growth, supported by robust research and development activities and healthcare spending[3].

Europe

Europe also has a substantial market share, characterized by advanced healthcare systems, high antibiotic consumption rates, and stringent regulatory standards. Countries like Germany, the UK, France, and Italy are prominent markets for combination therapies containing amoxicillin and clavulanate potassium[3].

Asia Pacific

The Asia Pacific region is witnessing rapid market growth, attributed to factors such as population growth, urbanization, improving access to healthcare services, and rising awareness about infectious diseases. Countries like China, India, Japan, South Korea, and Australia are key markets in this region[3].

Latin America and Middle East & Africa

Latin American and Middle Eastern & African countries are also experiencing growth, driven by improving healthcare infrastructure, rising healthcare spending, and the prevalence of antibiotic-resistant bacterial infections. Brazil, Mexico, Argentina, and Colombia are among the key markets in Latin America, while government initiatives to enhance healthcare access and affordability are driving growth in the Middle East and Africa[3].

Financial Trajectory

The global clavulanate potassium market was valued at USD 789.72 million in 2024 and is expected to grow to USD 950.77 million by 2033, at a CAGR of approximately 3% during this period. This financial trajectory reflects the increasing demand for combination therapies and the ongoing efforts to combat antibiotic resistance[3][5].

Key Players and Competitive Landscape

The market for amoxicillin and clavulanate potassium is competitive, with several key players involved in the manufacturing, distribution, and research of these combination therapies. Pharmaceutical companies are continuously investing in research and development to enhance the efficacy and safety profiles of these drugs, further driving market growth[3].

Challenges and Opportunities

Challenges

Despite the growth potential, the market faces challenges such as regulatory hurdles, the need for continuous innovation to stay ahead of antibiotic resistance, and the high cost of research and development.

Opportunities

The increasing prevalence of antibiotic-resistant infections presents a significant opportunity for the market. Government initiatives to combat antimicrobial resistance, improving healthcare infrastructure in emerging markets, and the demand for more effective antibiotic therapies are all driving factors that will continue to propel the market forward[3][5].

Clinical Pharmacology and Mechanism of Action

Amoxicillin and clavulanate potassium are well-absorbed from the gastrointestinal tract, with minimal effect on their pharmacokinetics when taken with or without food. Clavulanate potassium functions as a β-lactamase inhibitor, preventing bacterial enzymes from degrading amoxicillin and thus overcoming bacterial resistance mechanisms. This combination ensures that amoxicillin reaches effective concentrations in serum, urine, and tissues, making it a potent treatment for various bacterial infections[2][4].

Key Takeaways

• The amoxicillin and clavulanate potassium market is expected to grow significantly from 2023 to 2031.
• The market is driven by the increasing prevalence of antibiotic-resistant bacterial infections and the demand for effective combination therapies.
• The oral type of clavulanate potassium dominates the market, with the highest CAGR expected during the forecast period.
• North America, Europe, and the Asia Pacific are key regions driving market growth.
• The financial trajectory indicates a valuation of USD 950.77 million by 2033, at a CAGR of approximately 3%.

FAQs

Q: What is the primary driver of the amoxicillin and clavulanate potassium market? A: The primary driver is the increasing prevalence of antibiotic-resistant bacterial infections, which necessitates the use of potent β-lactamase inhibitors like clavulanate potassium to restore antibiotic efficacy.

Q: How does clavulanate potassium enhance the effectiveness of amoxicillin? A: Clavulanate potassium functions as a β-lactamase inhibitor, preventing bacterial enzymes from degrading amoxicillin and thus overcoming bacterial resistance mechanisms.

Q: What regions are expected to experience significant growth in the amoxicillin and clavulanate potassium market? A: North America, Europe, and the Asia Pacific are expected to be key regions driving market growth, along with emerging markets in Latin America and the Middle East & Africa.

Q: What is the projected market value of clavulanate potassium by 2033? A: The global clavulanate potassium market is expected to reach USD 950.77 million by 2033, growing at a CAGR of approximately 3% from 2024 to 2033.

Q: How does the combination of amoxicillin and clavulanate potassium affect its pharmacokinetics? A: The combination is well-absorbed from the gastrointestinal tract, with minimal effect on its pharmacokinetics when taken with or without food, ensuring effective concentrations in serum, urine, and tissues[4].

Cited Sources

1. Market Research Intellect: Global Amoxicillin And Clavulanate Potassium Market Size, Scope ...
2. Dechra-US: Amoxicillin and Clavulanate Potassium for Oral Suspension
3. Custom Market Insights: Global Potassium Clavulanate Market Size, Trends, Share 2033
4. FDA: Amoxicillin/Clavulanate Potassium Tablets
5. Custom Market Insights: Clavulanate Potassium Market Size Reach $950.77 Million 2033