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Last Updated: December 16, 2025

Bismuth subsalicylate; metronidazole; tetracycline hydrochloride - Generic Drug Details


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What are the generic drug sources for bismuth subsalicylate; metronidazole; tetracycline hydrochloride and what is the scope of freedom to operate?

Bismuth subsalicylate; metronidazole; tetracycline hydrochloride is the generic ingredient in two branded drugs marketed by Ailex Pharms Llc and Casper Pharma Llc, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for bismuth subsalicylate; metronidazole; tetracycline hydrochloride
US Patents:0
Tradenames:2
Applicants:2
NDAs:2
Clinical Trials: 3
DailyMed Link:bismuth subsalicylate; metronidazole; tetracycline hydrochloride at DailyMed
Recent Clinical Trials for bismuth subsalicylate; metronidazole; tetracycline hydrochloride

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

SponsorPhase
Akil Al IslamNA
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

See all bismuth subsalicylate; metronidazole; tetracycline hydrochloride clinical trials

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

US Patents and Regulatory Information for bismuth subsalicylate; 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
Casper Pharma Llc HELIDAC bismuth subsalicylate; metronidazole; tetracycline hydrochloride TABLET, CHEWABLE, TABLET, CAPSULE;ORAL 050719-001 Aug 15, 1996 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ailex Pharms Llc BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE bismuth subsalicylate; metronidazole; tetracycline hydrochloride TABLET, CHEWABLE, TABLET, CAPSULE;ORAL 202584-001 Nov 30, 2018 RX No Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Bismuth Subsalicylate, Metronidazole, and Tetracycline Hydrochloride

Last updated: July 27, 2025

Introduction

The pharmaceutical landscape for antimicrobial and gastrointestinal therapeutics sees continuous evolution driven by factors including rising antimicrobial resistance, expanding geographic markets, and shifting regulatory frameworks. This article analyzes the market dynamics and financial outlook for three significant drugs—bismuth subsalicylate, metronidazole, and tetracycline hydrochloride—highlighting their current positioning, growth drivers, challenges, and future revenue potential.


Market Overview of Key Drugs

Bismuth Subsalicylate

Bismuth subsalicylate is primarily used for gastrointestinal ailments such as traveler's diarrhea, indigestion, and peptic ulcers. Its role in combination therapies against Helicobacter pylori infection amplifies its healthcare significance. The drug's OTC availability in multiple markets further enhances its accessibility and consumption volume.

Metronidazole

Metronidazole is a broad-spectrum antimicrobial effective against anaerobic bacteria and protozoa, used for conditions including bacterial vaginosis, amoebiasis, and Clostridioides difficile infections. Its versatility, coupled with its generic status, positions it as a staple in infectious disease treatment.

Tetracycline Hydrochloride

Tetracycline remains a cornerstone antibiotic for various infections, including respiratory tract infections, Lyme disease, and cholera. Despite challenges from antibiotic resistance, its low cost and widespread use sustain its market presence, especially in emerging economies.


Market Dynamics

Drivers Fueling Growth

  • Rising Incidence of Infectious Diseases: The prevalence of bacterial, protozoal, and gastrointestinal infections continues to increase globally, especially in developing regions with limited sanitation infrastructure. The World Health Organization estimates that infectious diseases account for over 25% of all deaths worldwide, bolstering demand for effective antimicrobials like metronidazole and tetracycline [1].

  • Antimicrobial Resistance (AMR) and Therapeutic Niches: Growing antibiotic resistance pressures the development of combination therapies. Bismuth-containing regimens for H. pylori eradication exemplify this, potentially increasing demand for bismuth compounds.

  • Expanding Pharmaceutical Markets: Emerging markets in Asia-Pacific, Latin America, and Africa exhibit heightened pharmaceutical consumption due to rising healthcare investments and improved healthcare infrastructure, presenting growth opportunities for these drugs.

  • Generic Drug Market Stability: The dominance of generics for metronidazole and tetracycline provides stable revenue streams, with low entry barriers fostering competitive pricing but also prompting price erosion over time.

  • Regulatory Approvals & Indications Expansion: Ancillary approvals for new indications, improved formulations (e.g., sustained release), and combination therapies can unlock additional sales channels.

Challenges Impacting Market Trajectory

  • Antibiotic Resistance Concerns: Resistance diminishes efficacy, leading to a decline in patent-protected formulations and increased reliance on newer agents. Notably, tetracycline resistance among several pathogens limits its clinical utility[2].

  • Regulatory Hurdles & Evolving Guidelines: Stricter guidelines on antibiotic stewardship restrict usage and encourage the development of novel agents, potentially reducing long-term demand for older antibiotics reliant on generic manufacturing.

  • Competition & Market Saturation: Multiple generic manufacturers lead to price competition and margin erosion, particularly for metronidazole and tetracycline, which have been on the market extensively.

  • Safety and Side-Effect Profiles: Adverse effects such as Tetracycline's photosensitivity or Metronidazole's disulfiram-like reactions influence prescriber preferences, nudging toward newer therapies.


Financial Trajectory and Market Projections

Bismuth Subsalicylate

The global market for bismuth-based agents is projected to grow modestly at a compound annual growth rate (CAGR) of approximately 4-6% over the next five years, driven by:

  • Increasing awareness of H. pylori eradication therapies.
  • Continued OTC sales in North America, Europe, and Asia.
  • Growth in regions with high prevalence rates of gastric infections.

However, patent expirations and the proliferation of combination therapies with other antibiotics or probiotics temper explosive growth. The combined H. pylori eradication market could surpass $350 million globally by 2027 [3].

Metronidazole

The metronidazole market is expected to experience a CAGR of 3-5%, with revenues reaching $1.2 billion by 2027. The key factors involve:

  • Sustained demand for bacterial and parasitic infections.
  • Uptick in use for surgical and dental prophylaxis.
  • Expansion into veterinary and companion animal markets, adding diversification.

Patent expiries and widespread generic availability pressurize margins but ensure consistent volume-based revenue streams.

Tetracycline Hydrochloride

Despite resistance challenges, tetracycline’s market will likely grow at a modest CAGR of 2-4%, approaching $250 million globally. Its market resilience stems from:

  • Continued use in developing countries.
  • Limited alternative agents for specific indications like rickettsial diseases.
  • Ongoing production in generic markets, ensuring affordability.

However, resistance issues have curbed usage in some regions, impacting growth.


Future Outlook and Trends

  • The rise of antimicrobial stewardship programs will likely constrain broad-spectrum antibiotic sales but augment demand for targeted and combination therapies.

  • Biotechnology advances may lead to reformulations or novel delivery systems that extend drug lifecycles and market relevance.

  • Regulatory trends favoring newer, safer antibiotics might marginalize older drugs unless they are repositioned or partnered with combination therapies.

  • Market consolidation among generic manufacturers could influence pricing strategies and supply stability.

  • The increasing focus on resistance monitoring could result in tighter controls and impact sales in certain regions.


Key Takeaways

  • The combined market for bismuth subsalicylate, metronidazole, and tetracycline hydrochloride remains vital, with steady but moderate growth projected over the next five years.
  • Growth drivers include rising infection burdens, diagnostic improvements, and regional market expansion, primarily in emerging economies.
  • Challenges stem from antimicrobial resistance, regulatory pressures, and competitive generic landscapes, which are likely to compress margins and influence prescribing practices.
  • Strategic positioning through reforms, formulations, and combination therapies will be vital for sustaining revenue streams.
  • Stakeholders should monitor resistance patterns, regulatory developments, and market expansion in low- and middle-income countries to inform investment decisions.

FAQs

1. How will antimicrobial resistance impact the futures of these drugs?
Antimicrobial resistance is diminishing the efficacy of traditional antibiotics like tetracycline and metronidazole. This trend may lead to decreased usage, increased development of alternatives, and calls for combining these drugs with resistance-breaking agents, impacting market size.

2. Are there emerging markets expected to drive the growth of these drugs?
Yes, regions such as Asia-Pacific, Africa, and Latin America, experiencing rising infection rates and improving healthcare infrastructure, are anticipated to be main growth engines.

3. What role will combination therapies play in the future of these drugs?
Combination therapies, especially for H. pylori eradication (e.g., bismuth-based regimens), enhance efficacy and resistance management, potentially expanding market opportunities.

4. How do regulatory policies influence the market for these drugs?
Stringent regulatory controls on antibiotic use, safety standards, and approval pathways can constrain long-term growth but also encourage innovation and repositioning strategies.

5. What are the main competitive strategies for pharmaceutical companies in this space?
Firms focus on generic manufacturing efficiencies, development of fixed-dose combinations, reformulations, and expanding indications to sustain revenues amid patent expiries and resistance challenges.


References

[1] World Health Organization. Global Health Estimates 2021.

[2] Liu, C., et al. (2016). "Global prevalence of tetracycline resistance in bacterial pathogens." Emerging Infectious Diseases.

[3] MarketWatch. Global Bismuth Drugs Market Analysis & Forecast 2027.

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