AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN - Generic Drug Details

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

Amoxicillin; omeprazole magnesium; rifabutin is the generic ingredient in one branded drug marketed by Redhill and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amoxicillin; omeprazole magnesium; rifabutin has thirty patent family members in twenty-five countries.

One supplier is listed for this compound.

Summary for AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN

International Patents:	30
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

Dosage:

CAPSULE, DELAYED RELEASE;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.

Pharmacology for AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN

Drug Class	Penicillin-class Antibacterial Proton Pump Inhibitor Rifamycin Antimycobacterial
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

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

J04AB	Antibiotics
J04A	DRUGS FOR TREATMENT OF TUBERCULOSIS
J04	ANTIMYCOBACTERIALS
J	Antiinfectives for systemic use

US Patents and Regulatory Information for AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN

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
Redhill	TALICIA	amoxicillin; omeprazole magnesium; rifabutin	CAPSULE, DELAYED RELEASE;ORAL	213004-001	Nov 1, 2019		RX	Yes	Yes			Y
Redhill	TALICIA	amoxicillin; omeprazole magnesium; rifabutin	CAPSULE, DELAYED RELEASE;ORAL	213004-001	Nov 1, 2019		RX	Yes	Yes			Y
Redhill	TALICIA	amoxicillin; omeprazole magnesium; rifabutin	CAPSULE, DELAYED RELEASE;ORAL	213004-001	Nov 1, 2019		RX	Yes	Yes			Y

International Patents for AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN

Country	Patent Number	Title	Estimated Expiration
Japan	2016508516	ピロリ菌治療用医薬組成物
European Patent Office	2956149	COMPOSITIONS PHARMACEUTIQUES DESTINÉES AU TRAITEMENT D'HELICOBACTER PYLORI (PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF HELICOBACTER PYLORI)
Mexico	368536	COMPOSICION FARMACEUTICA PARA EL TRATAMIENTO DE HELICOBACTER PYLORI. (PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF HELICOBACTER PYLORI.)
Croatia	P20191559

AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amoxicillin, Omeprazole Magnesium, and Rifabutin

Introduction

The pharmaceutical market for antibiotics and proton pump inhibitors (PPIs) is complex and influenced by various factors, including healthcare expenditure, research and development, and market demand. This article will delve into the market dynamics and financial trajectory of three key drugs: amoxicillin, omeprazole magnesium, and rifabutin, particularly in the context of their combined use in treating Helicobacter pylori infections.

Amoxicillin Market Dynamics

Market Size and Growth

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

Growth Drivers

• Increased Healthcare Expenditure: Higher healthcare spending has led to wider accessibility and availability of amoxicillin, resulting in higher prescription rates and improved patient outcomes. For instance, healthcare expenditure in the US rose by 4.1% in 2022 to $4.5 trillion[1].
• Research and Development: Innovations such as reformulated versions of antibiotics are enhancing treatment outcomes. For example, the development of combination therapies involving amoxicillin is a significant growth driver[1].

Price Trends

The price of amoxicillin has shown an upward trend in the first half of 2024, particularly in Europe and North America. This is due to strong domestic demand, supply constraints, and logistical challenges. However, in the latter half of 2023, the market faced stagnation due to inflationary pressures and reduced consumer spending[5].

Omeprazole Magnesium Market Dynamics

Market Size and Growth

The omeprazole market was valued at $1.06 billion in 2023 and is expected to grow to $2.38 billion by 2036, with a CAGR of more than 6.4% during the forecast period. In 2024, the market size is estimated at $1.12 billion[2].

Growth Drivers

• Chronic Diseases: The increasing prevalence of chronic diseases such as cancer, diabetes, and respiratory ailments is driving the demand for omeprazole. By 2050, these diseases are expected to account for 90% of all global fatalities[2].
• Clinical Trials: Positive results from clinical trials, such as those involving the Talicia capsule which combines antibiotics and a PPI, are anticipated to boost the global demand for omeprazole[2].

Dosage Forms and Indications

• Capsule Segment: The capsule segment is expected to dominate the omeprazole market, occupying 52% of the market share by 2036. Omeprazole is primarily used to treat conditions like duodenal ulcers, gastric ulcers, gastroesophageal reflux, and erosive esophagitis[2].

Rifabutin Market Dynamics

Combined Therapies

Rifabutin is often used in combination with other drugs, such as amoxicillin and omeprazole, to treat Helicobacter pylori infections. The approval of combination therapies like Talicia (omeprazole magnesium, amoxicillin, and rifabutin) has been a significant factor in the market growth of rifabutin[4].

Regulatory Approvals

The FDA approval of Talicia in 2019 marked a significant milestone for the treatment of H. pylori infections. This combination therapy involves a fixed dose of omeprazole magnesium, amoxicillin, and rifabutin, taken orally for 14 days[4].

Financial Trajectory

Amoxicillin

The financial trajectory of amoxicillin is characterized by steady growth driven by increased healthcare expenditure and research activities. The market is expected to grow from $4.58 billion in 2023 to $5.44 billion by 2028, indicating a stable and growing revenue stream[1].

Omeprazole Magnesium

The omeprazole market is projected to experience significant growth, more than doubling from $1.06 billion in 2023 to $2.38 billion by 2036. This growth is fueled by the increasing prevalence of chronic diseases and positive clinical trial results[2].

Rifabutin

While specific financial projections for rifabutin alone are not as readily available, its use in combination therapies like Talicia suggests a positive financial outlook. The approval and market acceptance of such combination therapies are likely to drive revenue growth for rifabutin as part of these formulations[4].

Market Challenges

Supply Chain Disruptions

Logistical challenges, such as those caused by geopolitical tensions and supply chain disruptions, can impact the prices and availability of these drugs. For example, the collapse of the Key Bridge in Baltimore affected the amoxicillin market in North America[5].

Inflationary Pressures

Inflationary pressures and reduced consumer spending can lead to stagnation in the market. This was observed in the latter half of 2023 for amoxicillin, where market activities were curbed due to economic indicators and increased interest rates[5].

Regulatory and Clinical Aspects

FDA Approvals

The FDA approval of combination therapies like Talicia is crucial for market growth. These approvals ensure the safety and efficacy of the drugs, which in turn boosts market confidence and adoption[4].

Clinical Trials

Positive results from clinical trials, such as those involving omeprazole in H. pylori elimination therapy, are essential for increasing demand and driving market growth[2].

Regional Market Statistics

North America

North America holds a significant share of the omeprazole market, with 59.3% of the market share during the forecast period. The prevalence of H. pylori infections and peptic ulcers in the US contributes to this dominance[2].

Europe and Asia

Europe and Asia also play crucial roles in the market dynamics of these drugs. Europe saw a gradual upward trend in amoxicillin prices in the first half of 2024, while Asia experienced an upward trajectory in the first quarter of 2023 due to strong market recovery post-Lunar holidays[5].

Key Takeaways

• Steady Growth: The amoxicillin market is expected to see steady growth, driven by increased healthcare expenditure and research activities.
• Combination Therapies: The approval of combination therapies like Talicia has been a significant factor in the market growth of omeprazole magnesium and rifabutin.
• Chronic Diseases: The increasing prevalence of chronic diseases is driving the demand for omeprazole.
• Supply Chain and Economic Factors: Logistical challenges and inflationary pressures can impact the prices and availability of these drugs.
• Regulatory Approvals: FDA approvals and positive clinical trial results are crucial for market growth and adoption.

FAQs

What is the projected market size for amoxicillin by 2028?

The amoxicillin market is expected to grow to $5.44 billion by 2028 at a CAGR of 3.5%[1].

How is the omeprazole market expected to grow by 2036?

The omeprazole market is expected to grow from $1.06 billion in 2023 to $2.38 billion by 2036, with a CAGR of more than 6.4%[2].

What is the significance of the FDA approval of Talicia?

The FDA approval of Talicia (omeprazole magnesium, amoxicillin, and rifabutin) is significant for the treatment of H. pylori infections, ensuring the safety and efficacy of the combination therapy[4].

How do supply chain disruptions affect the market for these drugs?

Supply chain disruptions, such as those caused by geopolitical tensions and logistical challenges, can lead to price increases and availability issues for these drugs[5].

What role do chronic diseases play in the demand for omeprazole?

The increasing prevalence of chronic diseases such as cancer, diabetes, and respiratory ailments is driving the demand for omeprazole, as it is used to treat conditions like gastroesophageal reflux and erosive esophagitis[2].

Sources

1. GlobeNewswire: Amoxicillin Market Research Report 2024.
2. ResearchNester: Omeprazole Market Size & Share | Growth Forecasts 2036.
3. Duke University: Pharmaceutical Progress for Neglected Diseases.
4. FDA: 213004Orig1s000 - Talicia (Omeprazole magnesium, Amoxicillin, and Rifabutin) Delayed-Release Capsules.
5. Procurement Resource: Amoxicillin Price Trend and Forecast.