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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN
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	9,603,806		Y
Redhill	TALICIA	amoxicillin; omeprazole magnesium; rifabutin	CAPSULE, DELAYED RELEASE;ORAL	213004-001	Nov 1, 2019		RX	Yes	Yes	10,238,606		Y
Redhill	TALICIA	amoxicillin; omeprazole magnesium; rifabutin	CAPSULE, DELAYED RELEASE;ORAL	213004-001	Nov 1, 2019		RX	Yes	Yes	11,135,172		Y
Redhill	TALICIA	amoxicillin; omeprazole magnesium; rifabutin	CAPSULE, DELAYED RELEASE;ORAL	213004-001	Nov 1, 2019		RX	Yes	Yes	9,050,263		Y
Redhill	TALICIA	amoxicillin; omeprazole magnesium; rifabutin	CAPSULE, DELAYED RELEASE;ORAL	213004-001	Nov 1, 2019		RX	Yes	Yes	11,931,463		Y
Redhill	TALICIA	amoxicillin; omeprazole magnesium; rifabutin	CAPSULE, DELAYED RELEASE;ORAL	213004-001	Nov 1, 2019		RX	Yes	Yes

International Patents for AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN

Country	Patent Number	Title	Estimated Expiration
Israel	240387	תכשירי רוקחות לטיפול בהליקובקטר פילורי (Pharmaceutical compositions for the treatment of helicobacter pylori)
Slovenia	2956149
Russian Federation	2015138708	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ ОТ HELICOBACTER PYLORI
Poland	2956149
Denmark	2956149
World Intellectual Property Organization (WIPO)	2014127025

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

Last updated: July 31, 2025

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Introduction

Pharmaceuticals constitute a vital segment of global healthcare, underpinning the management of infectious diseases, gastrointestinal disorders, and tuberculosis. Among the diverse class of drugs, amoxicillin, omeprazole magnesium, and rifabutin each serve critical, though distinct, therapeutic markets. Understanding the current market dynamics and financial trajectories for these drugs offers invaluable insights for stakeholders, including investors, pharmaceutical companies, and healthcare policymakers.

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Amoxicillin: Market Overview and Financial Trajectory

Market Landscape

Amoxicillin, a broadly used beta-lactam antibiotic, remains a cornerstone in treating bacterial infections, including pneumonia, urinary tract infections, and otitis media. Its extensive use, coupled with established manufacturing processes, confers a resilient market presence. The global amoxicillin market was valued at approximately USD 2.3 billion in 2022, with projections indicating a compound annual growth rate (CAGR) of around 4.2% through 2030 [1].

Market Drivers

• Antibiotic Resistance Concerns: Rising antimicrobial resistance (AMR) poses challenges to drug efficacy, questioning the longevity of amoxicillin's dominance. The World Health Organization (WHO) underscores the urgency to develop novel antibiotics; however, amoxicillin's proven efficacy sustains demand [2].
• Generic Market Penetration: The expiration of patent protections has facilitated widespread generic manufacturing, reducing prices and expanding access—especially in emerging economies.
• Infectious Disease Burden: A persistent global burden of bacterial infections continues to fuel demand, especially in low- and middle-income countries (LMICs). This demographic benefit sustains stable revenue streams.

Financial Trajectory

Despite concerns of rising resistance, amoxicillin's market remains robust, sustained by affordability and accessibility. Industry forecasts suggest moderate growth, driven predominantly by generics' market expansion. Price erosion remains a factor, yet high volume sales mitigate revenue declines. However, economic pressures from healthcare systems and antimicrobial stewardship programs may temper long-term profitability.

Supply Chain and Competitive Landscape

The manufacturing landscape is highly competitive, with numerous regional players. Supply chain resilience, notably post-COVID-19 disruptions, has been a concern, prompting investments in diversified manufacturing bases. Regulatory hurdles vary by region but generally favor established generics.

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Omeprazole Magnesium: Market Overview and Financial Trajectory

Market Landscape

Omeprazole magnesium, a proton pump inhibitor (PPI), is indicated for gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. The global PPI market reached an estimated USD 5.8 billion in 2022, with a CAGR of 3.7% projected through 2030 [3].

Market Drivers

• Rising Gastrointestinal Disorders: Increasing prevalence of GERD and peptic ulcer disease, especially in aging populations, directly correlates with sustained demand.
• Brand to Generic Transition: Omeprazole was among the first PPIs to lose patent protection, facilitating rapid generic entry. This shift significantly pushes down prices but also widens access.
• Potential for Line Extensions: Development of combination therapies and novel formulations may generate incremental revenue streams.

Financial Trajectory

Generic proliferation has resulted in substantial price reductions, challenging branded blockbuster profitability. Nonetheless, volume-driven revenue sustains the market. Notably, increasing off-label indications, such as in combination therapies for Helicobacter pylori eradication, may bolster revenues.

However, recent safety concerns regarding long-term PPI use—linked to risks such as renal issues and fractures—may influence prescribing patterns and regulatory scrutiny. Such factors could modulate future market growth.

Emerging Trends

Innovations in PPI formulations—like liquid suspensions and targeted delivery systems—aim to improve patient compliance and therapeutic outcomes, potentially opening novel market segments.

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Rifabutin: Market Overview and Financial Trajectory

Market Landscape

Rifabutin, a rifamycin derivative, is primarily used in treating drug-resistant and multidrug-resistant tuberculosis (TB). The drug is incorporated into complex combination regimens, often reserved for cases intolerant or unresponsive to other treatments. The global TB drug market, including rifabutin, is estimated to reach USD 1.2 billion by 2030, growing at a CAGR of approximately 4.0% [4].

Market Drivers

• Emergence of Multidrug-Resistant TB: The escalation of MDR-TB and XDR-TB cases amplifies demand for rifabutin-containing regimens.
• Global TB Control Initiatives: Funding from WHO, global health agencies, and government programs enhances access, especially in high-burden regions such as India, China, and parts of Africa.
• Drug Supply Challenges: Limited manufacturing capacity and supply constraints, exacerbated by intellectual property considerations and funding limitations, influence availability and pricing.

Financial Trajectory

Rifabutin’s niche positioning affords it a relatively steady, if modest, market share. Its high unit cost and specialized use limit volume growth but secure premium pricing in select markets. The emergence of newer agents and combination therapies, including bedaquiline and delamanid, threaten broader market adoption for rifabutin in resistant TB cases.

Research and development efforts aim to improve formulations, enhance stability, and reduce manufacturing costs, potentially expanding market access. However, global funding uncertainties and supply chain constraints remain significant hurdles.

Strategic Considerations

The essential role of rifabutin in multidrug-resistant TB strategies sustains demand, yet market factors—like patent expirations and regional procurement practices—will shape future financial trajectories.

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Market Challenges and Opportunities

• Amoxicillin: Resistance development and antibiotic stewardship present ongoing challenges, yet expanding-access initiatives and generic proliferation offer growth opportunities.
• Omeprazole Magnesium: Price competition and safety concerns mandate continuous innovation. Opportunities lie in developing targeted formulations and combination therapies.
• Rifabutin: Market niche concentration requires strategic partnerships and funding support. Innovations to improve supply chain resilience and formulations could expand market penetration.

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Regulatory and Competitive Factors

Regulatory agencies are increasingly emphasizing antimicrobial stewardship and safety, influencing approval and post-market surveillance. Patent landscapes and generic entries significantly impact pricing and profit margins across all three drugs. Strategic patent management and lifecycle extension innovations are critical to sustain revenues.

Emerging biosimilar and bioconjugate technologies may disrupt existing markets, especially for chemically similar or functionally identical drugs. Digital health integration, including pharmacovigilance, enhances market credibility.

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Key Takeaways

• Market Resilience: Despite challenges posed by resistance, safety concerns, and price competition, amoxicillin, omeprazole magnesium, and rifabutin maintain significant roles within their respective segments, supported by volume and incremental innovation.
• Growth Drivers: Rising disease prevalence, especially in LMICs, along with evolving treatment protocols, underpin sustained demand.
• Competitive Landscape: Generic proliferation and patent expirations intensify price competition; strategic lifecycle management remains vital.
• Emerging Opportunities: Innovations in formulations, combination therapies, and supply chain improvements can drive future growth.
• Strategic Positioning: Stakeholders must navigate regulatory hurdles, adapt to safety trends, and leverage global health initiatives to optimize financial outcomes.

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FAQs

1. How will antimicrobial resistance affect amoxicillin’s market in the coming decade?
Antimicrobial resistance is a significant concern that could limit amoxicillin’s efficacy; however, ongoing antibiotic stewardship and development of combination therapies may sustain its relevance. The market’s volume-driven nature provides some buffer despite potential price pressures.

2. What factors are influencing the decline in omeprazole magnesium’s prices?
Patent expirations and the entry of generic competitors have precipitated price reductions. Additionally, safety concerns regarding long-term PPI use may influence prescribing behaviors, potentially reducing off-label applications.

3. Is rifabutin a viable long-term investment in the face of emerging TB treatments?
Yes, particularly in managing multidrug-resistant TB, where it remains a critical component. However, market growth may plateau as new agents advance; strategic partnerships and formulation improvements are essential to maintain its relevance.

4. What regional factors most impact these drugs’ markets?
Emerging economies with high disease burdens and less regulatory rigidity tend to drive volume growth. Conversely, regulatory tightening and safety protocols in developed markets can restrict growth but also create niches for specialized formulations.

5. Which innovations could most significantly influence these drugs' trajectories?
Formulation enhancements, combination therapies, supply chain resilience, and targeted delivery systems are key innovations with the potential to extend product life cycles and expand market reach.

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References

[1] MarketResearch.com, “Global Amoxicillin Market Forecast,” 2022.
[2] WHO, “Antimicrobial Resistance Global Report,” 2019.
[3] Grand View Research, “Proton Pump Inhibitors Market Size & Trends,” 2023.
[4] GlobalMarketInsights, “TB Drugs Market Analysis,” 2022.