AMOXICILLIN - Generic Drug Details

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

Amoxicillin is the generic ingredient in twenty-five branded drugs marketed by Aurobindo, Chartwell, Hikma Pharms, Labs Atral, Micro Labs, Mylan, Sandoz, Strides Pharma, Sun Pharm Inds Ltd, Teva, Glaxosmithkline, Us Antibiotics, Apothecon, Parke Davis, Wyeth Ayerst, Aurobindo Pharma Ltd, Chartwell Rx, Endo Operations, Hikma, Pragma, Ranbaxy Labs Ltd, Ani Pharms, Rising, Takeda Pharms Usa, Cumberland, Phathom, Aurobindo Pharma, Cipla, Deva Holding As, Micro Labs Ltd India, Sandoz Inc, Apotex Inc, Teva Pharms Usa, and Redhill, and is included in one hundred and twenty-six NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amoxicillin has eleven patent family members in six countries.

There are forty-six drug master file entries for amoxicillin. Thirty-six suppliers are listed for this compound.

Summary for AMOXICILLIN

International Patents:	11
US Patents:	12
Tradenames:	25
Applicants:	34
NDAs:	126
Drug Master File Entries:	46
Finished Product Suppliers / Packagers:	36
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	581
Patent Applications:	6,473
Drug Prices:	Drug price trends for AMOXICILLIN
Drug Sales Revenues:	Drug sales revenues for AMOXICILLIN
What excipients (inactive ingredients) are in AMOXICILLIN?	AMOXICILLIN excipients list
DailyMed Link:	AMOXICILLIN at DailyMed

See drug prices for AMOXICILLIN

See drug sales revenues for AMOXICILLIN

Recent Clinical Trials for AMOXICILLIN

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

Sponsor	Phase
National Dental PBRN	Phase 3
Rutgers, The State University of New Jersey	Phase 3
National Institute of Dental and Craniofacial Research (NIDCR)	Phase 3

See all AMOXICILLIN clinical trials

Pharmacology for AMOXICILLIN

Drug Class

Penicillin-class Antibacterial

Medical Subject Heading (MeSH) Categories for AMOXICILLIN

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for AMOXICILLIN

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

US Patents and Regulatory Information for AMOXICILLIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Redhill	TALICIA	amoxicillin; omeprazole magnesium; rifabutin	CAPSULE, DELAYED RELEASE;ORAL	213004-001	Nov 1, 2019		RX	Yes	Yes			Y
Chartwell Rx	AMOXICILLIN	amoxicillin	TABLET;ORAL	065344-001	Jan 15, 2009		DISCN	No	No
Us Antibiotics	AUGMENTIN '200'	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	050725-001	May 31, 1996		DISCN	Yes	No
Strides Pharma	AMOXICILLIN	amoxicillin	CAPSULE;ORAL	062884-001	Feb 25, 1988		DISCN	No	No

Expired US Patents for AMOXICILLIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008

International Patents for AMOXICILLIN

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007067770
Japan	5788142
Japan	2010511607
Canada	2635378	COMPOSITIONS PHARMACEUTIQUES ET METHODES POUR ERADICATION BACTERIENNE AMELIOREE (PHARMACEUTICAL COMPOSITIONS AND METHODS FOR IMPROVED BACTERIAL ERADICATION)

AMOXICILLIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Amoxicillin

Market Size and Growth Projections

The global amoxicillin market is experiencing steady growth, driven by several key factors. As of 2023, the market size was valued at $4.58 billion and is expected to grow to $4.74 billion in 2024, with a compound annual growth rate (CAGR) of 3.4%[1].

By 2028, the market is projected to reach $5.44 billion at a CAGR of 3.5%, and by 2029, it is anticipated to reach $5.51 billion with a CAGR of 2.0%[1][3].

Looking further ahead, the market is expected to expand to $6.1 billion by 2033, growing at a CAGR of 2.5% from 2024 to 2033[5].

Drivers of Market Growth

Increased Understanding and Approval of Indications

The rising understanding of antibiotics and their approved indications by regulatory bodies such as the U.S. FDA are significant drivers. Amoxicillin is approved for various conditions, including Helicobacter pylori eradication, ear, nose, and throat infections, lower respiratory tract infections, and acute bacterial sinusitis[3].

Research Activities and Developments

Accelerated research activities and developments in the pharmaceutical sector are boosting the market. Innovations such as reformulated versions of vonoprazan tablets for treating Helicobacter pylori infections are enhancing patient outcomes and driving growth[1].

Prevalence of Infectious Diseases

The growing prevalence of infectious diseases, including lower respiratory infections, urinary tract infections, and skin infections, is a major driver. The emergence of antibiotic-resistant pathogens further underscores the need for effective antibiotics like amoxicillin[1][5].

Healthcare Expenditure

Increased healthcare expenditure is another key factor. Higher spending ensures wider accessibility and availability of amoxicillin, leading to higher prescription rates and improved patient outcomes. For instance, healthcare expenditure in the U.S. rose by 4.1% in 2022, contributing to the market's growth[1].

Regional Analysis

Asia-Pacific

The Asia-Pacific region is witnessing the highest growth due to increasing cases of cardiovascular diseases and a rapidly aging population. This demographic shift is driving the demand for amoxicillin in this region[3].

North America

North America dominates the market due to the high prevalence of respiratory infections and advanced healthcare facilities. Strong domestic demand and supply constraints in this region have also contributed to the upward trend in amoxicillin prices[3][4].

Market Trends

Generic Amoxicillin

There is a surge in demand for generic amoxicillin, which accounts for a significant portion of the market. Generic antibiotics are top-selling products, and their low prices make them accessible to a broader population[2].

Combination Therapies and Immunotherapy

The focus on combination therapies and immunotherapy is a notable trend. These advancements are expected to shape the future landscape of the amoxicillin market, offering better treatment options and improving patient outcomes[1].

Probiotics

Interest in probiotics is also on the rise, as they are seen as complementary to antibiotic treatments, helping to mitigate side effects and support gut health[1].

Financial Performance and Revenue

Revenue from Antibiotics

The revenue from antibiotics, including amoxicillin, is significant but varies widely. For example, in the U.S., the top-selling antibiotics, including generic amoxicillin, collectively generate less than $2 billion in annual revenue. Amoxicillin itself generates around $213.2 million annually[2].

Comparison with Other Medicines

The financial performance of antibiotics is modest compared to other medicines. For instance, novel antibiotics launched between 2010 and 2020 had an average global annual revenue of $46 million and a median annual revenue of $16 million. In contrast, blockbuster drugs like Humira and Crestor have cumulative sales in the tens of billions of dollars[2].

Incentives for New Antibiotics

To encourage the development of new antibiotics, various incentives are being proposed. For example, a yearly pull incentive of $260 million over ten years could provide a total reward of approximately $2.6 billion, which is seen as necessary to attract investment given the high risks and costs associated with developing new antibiotics[2].

Price Trends

Global Price Dynamics

The price of amoxicillin has shown varying trends across different regions. In the first half of 2024, prices in Europe and North America saw an upward trajectory due to strong demand and supply constraints. In contrast, prices in Asia declined in the latter part of 2023 due to muted demand and reduced production costs[4].

Regional Price Variations

In North America, the market experienced positive price trends driven by strong domestic demand and logistical challenges. In Europe, prices were influenced by geopolitical tensions and higher shipping costs. In Asia, the prices fell due to weak market sentiments and reduced demand from downstream industries[4].

Challenges and Opportunities

Antimicrobial Resistance

The rising prevalence of antimicrobial resistance poses a significant challenge to the amoxicillin market. This has led to increased focus on developing new antibiotics and alternative treatments[1].

Economic Impact

The economic impact of antimicrobial resistance is substantial, with estimated annual direct and indirect costs running into billions of dollars. This underscores the need for continued investment in antibiotic research and development[2].

Key Takeaways

• The global amoxicillin market is expected to grow steadily, driven by increasing prevalence of infectious diseases, advancements in antibiotic therapy, and higher healthcare expenditure.
• Regional growth varies, with Asia-Pacific and North America being key markets.
• Generic amoxicillin and combination therapies are significant trends shaping the market.
• Financial incentives are crucial for encouraging the development of new antibiotics.
• Price trends are influenced by regional demand, supply constraints, and geopolitical factors.

FAQs

1. What is the projected market size of amoxicillin by 2029? The global amoxicillin market is expected to reach $5.51 billion by 2029, growing at a CAGR of 2.0%[3].

2. What are the main drivers of the amoxicillin market? The main drivers include increased understanding and approval of indications, research activities, prevalence of infectious diseases, and higher healthcare expenditure[1][3].

3. How does the demand for generic amoxicillin impact the market? The demand for generic amoxicillin is a significant trend, as generic antibiotics account for the majority of the market and are top-selling products due to their low prices[2].

4. What are the regional dynamics influencing the amoxicillin market? Asia-Pacific is witnessing high growth due to an aging population and increasing cardiovascular diseases, while North America dominates due to advanced healthcare facilities and high prevalence of respiratory infections[3].

5. How do financial incentives affect the development of new antibiotics? Financial incentives, such as yearly pull incentives, are crucial for encouraging investment in new antibiotic development, given the high risks and costs involved[2].

Cited Sources

1. GlobeNewswire: "Amoxicillin Market Research Report 2024: Combination Therapies and Immunotherapy Trends Shaping Future Landscape - Global Long-term Forecast to 2028 and 2033"[1].
2. Harvard Kennedy School: "Sizing A Market Entry Reward for the Development of New Antibiotics"[2].
3. Data Bridge Market Research: "Global Amoxicillin Market – Industry Trends and Forecast to 2029"[3].
4. Procurement Resource: "Amoxicillin Price Trend and Forecast"[4].
5. Custom Market Insights: "Global Amoxicillin Market Size Reach $6.1 Billion 2033 - CMI"[5].