Bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride - Generic Drug Details

What are the generic drug sources for bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride and what is the scope of patent protection?

Bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride is the generic ingredient in two branded drugs marketed by Novast Labs, Ph Health, and Labs Juvise, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	3
Clinical Trials:	3
DailyMed Link:	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride at DailyMed

Recent Clinical Trials for bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride

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

Sponsor	Phase
American University of Beirut Medical Center	Phase 4
The University of Texas Health Science Center, Houston	Phase 4
Axcan Pharma	Phase 3

See all bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride clinical trials

Pharmacology for bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride

Drug Class

Bismuth Nitroimidazole Antimicrobial Tetracycline-class Antimicrobial

Anatomical Therapeutic Chemical (ATC) Classes for bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

A02BX	Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD)
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

D06AA	Tetracycline and derivatives
D06A	ANTIBIOTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

D06BX	Other chemotherapeutics
D06B	CHEMOTHERAPEUTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

G01AF	Imidazole derivatives
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

J01AA	Tetracyclines
J01A	TETRACYCLINES
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J01XD	Imidazole derivatives
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

P01AB	Nitroimidazole derivatives
P01A	AGENTS AGAINST AMOEBIASIS AND OTHER PROTOZOAL DISEASES
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

S03AA	Antiinfectives
S03A	ANTIINFECTIVES
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

Paragraph IV (Patent) Challenges for BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PYLERA	Capsules	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	140 mg/125 mg/ 125 mg	050786	1	2014-08-12

US Patents and Regulatory Information for bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ph Health	BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	205770-001	Mar 6, 2023	AB	RX	No	No
Labs Juvise	PYLERA	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	050786-001	Sep 28, 2006	AB	RX	Yes	Yes
Novast Labs	BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	217511-001	Jul 3, 2023	AB	RX	No	No

Expired US Patents for bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Labs Juvise	PYLERA	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	050786-001	Sep 28, 2006
Labs Juvise	PYLERA	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	050786-001	Sep 28, 2006
Labs Juvise	PYLERA	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	050786-001	Sep 28, 2006

Market Dynamics and Financial Trajectory for Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Hydrochloride

Last updated: July 27, 2025

Introduction

The combination of bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride forms a cornerstone therapy in the management of Helicobacter pylori infections and related gastrointestinal conditions. The evolving landscape of antibiotic resistance, regulatory policies, and technological advancements shape the market dynamics of these drugs. This analysis delineates current trends and projects the financial trajectory of these key pharmaceuticals, providing a comprehensive outlook for stakeholders.

Market Overview

The global gastrointestinal therapeutic market, where these antibiotics primarily operate, is valued at approximately USD 25 billion in 2022, with a compound annual growth rate (CAGR) of around 4% over the next five years [1]. The impetus stems from increasing prevalence of H. pylori infections and peptic ulcer disease, especially in emerging economies. The drugs in focus—bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride—are vital components of eradication regimens, such as bismuth quadruple therapy.

Regulatory Landscape

Regulatory agencies like the FDA and EMA have tightened approvals for antibiotics due to antimicrobial resistance (AMR) concerns. While some formulations are off-patent, new formulations and combinations attaining regulatory clearance contribute to sustained market activity. The World Health Organization (WHO) emphasizes rational antibiotic use, influencing prescription patterns globally.

Market Drivers

Rise in H. pylori Infection Incidences

H. pylori affects roughly 50% of the global population, with higher burdens in Asia, Latin America, and Africa [2]. Its eradication is essential to prevent complications like gastric carcinoma and MALT lymphoma. As a result, demand for effective combination therapies involving bismuth subcitrate, metronidazole, and tetracycline has surged.

Antibiotic Resistance and Treatment Regimens

Resistance to metronidazole and tetracycline varies geographically, prompting the development of tailored therapies. Notably, bismuth-based quadruple therapy regimens have regained prominence due to increasing resistance to clarithromycin, another commonly used antibiotic. This resurgence sustains the demand for these agents.

Advancements in Formulation and Delivery

Innovations such as sustained-release formulations and combination packs enhance patient compliance and therapeutic efficacy, driving market growth. Additionally, the off-patent status for several formulations encourages generic proliferation, widening access and lowering costs.

Market Challenges

Antimicrobial Resistance (AMR)

AMR remains a significant barrier. Resistance development diminishes drug efficacy, necessitating higher doses or alternative therapies, impacting sales and prompting R&D investments for new agents.

Regulatory and Patent Challenges

Patent expirations, especially for metronidazole and tetracycline, have led to increased generic competition, reducing profit margins for innovators. Regulatory hurdles for new combinations or formulations can delay market entry.

Safety and Toxicity Concerns

Adverse effects such as metronidazole-induced neurotoxicity and tetracycline's contraindication in children limit their usage, influencing prescribing habits and market dynamics.

Financial Trajectory and Market Projections

Current Market Size and Segmentation

The combined global market for these antibiotics within H. pylori eradication regimens is estimated at USD 1.2 billion in 2022. North America and Europe collectively account for 45% of sales, driven by sophisticated healthcare infrastructure and high prescription rates. Emerging markets in Asia-Pacific and Latin America present growth opportunities due to escalating infection rates and improving healthcare access.

Forecasted Growth

Projections indicate a CAGR of approximately 3.5%-4.5% over the next five years. Growth drivers include:

• Increasing prevalence of H. pylori infections, especially in developing countries.
• Enhancement of treatment guidelines, favoring multidrug regimens.
• Expansion of generic markets, reducing costs and enlarging consumer bases.

Regional Variations

• In North America and Europe, market growth will stabilize owing to high current penetration and mature treatment protocols.
• Asia-Pacific and Latin America are expected to experience higher growth rates (>5%) due to expanding healthcare infrastructure, increasing awareness, and higher disease burdens.

Impact of Antibiotic Resistance

While resistance complicates treatment, the integration of these agents into novel combination therapies sustains their relevance. The development of resistance monitoring tools and personalized medicine approaches may influence future prescribing, impacting sales volume but potentially improving treatment success rates.

Innovations and Future Trends

• Development of adjunct therapies reducing dosages or extending intervals.
• Potential biosimilars and generic formulations, further lowering prices.
• Digital health integration to optimize therapy adherence, potentially reducing re-treatment rates and influencing long-term revenue streams.

Competitive Landscape

Major pharmaceutical companies and generics manufacturers dominate this space. Key players include:

• GSK and Yamanouchi (original developers) with licensed formulations.
• Teva, Mylan, and other generics producers expanding market share.

Generic penetration reduces prices but maintains volume-driven revenues. Patent litigation and licensing agreements impact market access and profitability.

Regulatory and Policy Impact

Government initiatives targeting AMR, such as Antimicrobial Stewardship Programs, influence prescription behaviors, potentially dampening sales of broad-spectrum antibiotics and favoring targeted, narrow-spectrum agents. Harmonization of guidelines globally ensures consistent treatment approaches, affecting market consistency.

Conclusion

The market for bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride remains vibrant, underpinned by the persistent burden of H. pylori infections and evolving treatment paradigms. While challenges such as AMR and patent expiries exist, ongoing innovations, expanding markets in emerging economies, and regulatory adaptations portend a steady financial trajectory. Stakeholders should focus on developing resistance mitigation strategies, fostering formulation innovations, and navigating regulatory landscapes to optimize value.

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Key Takeaways

• The global demand for antibiotics used in H. pylori eradication remains strong, with a projected CAGR of approximately 4% over five years.
• Resistance development is a key challenge; however, combination therapies incorporating these agents continue to adapt and evolve.
• Generics and biosimilars will drive down prices but sustain market volume—beneficial for access but pressure margins.
• Emerging markets present substantial growth opportunities due to rising infection prevalence and improving healthcare infrastructure.
• Strategic innovation and adherence to antimicrobial stewardship policies are critical to maintaining market stability and growth.

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FAQs

1. How does antimicrobial resistance affect the market for bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride?
Antimicrobial resistance reduces drug efficacy, leading to declining success rates in eradication therapies. This trend prompts the development of new formulations, combination regimens, and stewardship policies, influencing sales dynamics and encouraging innovation.

2. What role do generic manufacturers play in the market for these antibiotics?
Generics significantly increase market penetration, lower costs, and expand access, especially in emerging economies. They also precipitate price competition, affecting profit margins for branded drug producers.

3. Are there emerging alternative therapies that could replace these antibiotics?
Research into novel therapies, including probiotic-based treatments, vaccines, and targeted antimicrobial agents, continues. However, current reliance on these antibiotics remains predominant due to their proven efficacy and established treatment protocols.

4. How might regulatory policies impact the future market for these drugs?
Stringent regulations aimed at combating AMR may restrict usage, favor targeted therapies, or require new formulations. Conversely, policies promoting access and innovation could stimulate development and approval processes.

5. What are the key factors for stakeholders to monitor for future market success?
Key factors include resistance patterns, regulatory shifts, technological innovations, geopolitical developments influencing healthcare infrastructure, and marketing strategies around combination therapies.

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References

[1] Market Research Future, Global Gastrointestinal Therapeutic Market Analysis, 2022.
[2] WHO, Global Prevalence of Helicobacter pylori, 2021.