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Last Updated: December 22, 2024

BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE Drug Patent Profile


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When do Bismuth Subsalicylate, Metronidazole And Tetracycline Hydrochloride patents expire, and what generic alternatives are available?

Bismuth Subsalicylate, Metronidazole And Tetracycline Hydrochloride is a drug marketed by Ailex Pharms Llc and is included in one NDA.

The generic ingredient in BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE is bismuth subsalicylate; metronidazole; tetracycline hydrochloride. There are twenty-two drug master file entries for this compound. Additional details are available on the bismuth subsalicylate; metronidazole; tetracycline hydrochloride profile page.

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Summary for BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE
Drug patent expirations by year for BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE
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SponsorPhase
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
M.D. Anderson Cancer CenterPhase 2

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US Patents and Regulatory Information for BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

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

Introduction

Bismuth subsalicylate, metronidazole, and tetracycline hydrochloride is a combination therapy widely used for the treatment of Helicobacter pylori (H. pylori) infections and associated duodenal ulcer disease. This article delves into the market dynamics and financial trajectory of this drug combination.

Market Overview

The market for H. pylori treatment is driven by the high prevalence of the infection globally, which is estimated to affect over 50% of the world's population. The combination of bismuth subsalicylate, metronidazole, and tetracycline hydrochloride is a key player in this market due to its efficacy in eradicating H. pylori and preventing duodenal ulcer recurrence[2][3][4].

Indications and Usage

This drug combination is specifically indicated for the eradication of H. pylori in patients with active duodenal ulcers or a history of duodenal ulcer disease within the past five years. It is often used in conjunction with acid suppressors like omeprazole to enhance treatment outcomes[2][3][4].

Competitive Landscape

The market for H. pylori treatments is competitive, with various antibiotic combinations and proton pump inhibitor (PPI) therapies available. However, the combination of bismuth subsalicylate, metronidazole, and tetracycline hydrochloride remains a preferred choice due to its proven efficacy and relatively low cost compared to other treatments.

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of this drug combination. The FDA approved this combination in 2006, and it has since been subject to various guidelines and warnings, particularly regarding the potential carcinogenicity of metronidazole and the risk of drug-resistant bacteria[2][3].

Financial Performance

The financial performance of this drug combination is influenced by several factors, including prescription rates, pricing strategies, and competition from generic alternatives.

Prescription Rates

The prescription rates for bismuth subsalicylate, metronidazole, and tetracycline hydrochloride have remained stable due to the ongoing need for effective H. pylori treatments. The combination is often prescribed for a short duration (typically 10-14 days), which can impact revenue but also ensures a steady demand[3][4].

Pricing Strategies

The pricing of this drug combination varies by region and is influenced by healthcare policies and reimbursement rates. In general, the combination is priced competitively to ensure affordability and accessibility, which helps maintain market share[4].

Generic Competition

The introduction of generic versions of this drug combination has impacted the financial trajectory. Generic alternatives can reduce the market share of the branded version, but the established reputation and efficacy of the original combination help it retain a significant market presence[2][3].

Market Trends

Several trends are shaping the market for bismuth subsalicylate, metronidazole, and tetracycline hydrochloride:

Increasing Prevalence of H. pylori Infections

The global prevalence of H. pylori infections continues to drive demand for effective treatments. This trend is particularly pronounced in developing countries where access to healthcare is improving[2].

Growing Awareness of Gastrointestinal Health

There is an increasing awareness of gastrointestinal health, leading to more patients seeking medical attention for symptoms related to H. pylori infections. This awareness contributes to higher prescription rates for this drug combination[4].

Advances in Diagnostic Techniques

Advances in diagnostic techniques, such as breath tests and endoscopy, have improved the detection rate of H. pylori infections. This has led to more targeted treatments and increased demand for the combination therapy[3].

Challenges and Opportunities

Resistance to Antibiotics

One of the significant challenges facing this drug combination is the growing resistance to antibiotics. This necessitates the development of new treatment regimens and alternative therapies, which can impact the market share of the current combination[2][3].

Side Effects and Safety Concerns

The combination is associated with several side effects, including darkening of the tongue and stool, and more serious reactions like Stevens-Johnson syndrome. These safety concerns can affect patient compliance and prescription rates[3][4].

Emerging Markets

Emerging markets, particularly in Asia and Latin America, present opportunities for growth. As healthcare infrastructure improves in these regions, the demand for effective H. pylori treatments is expected to increase[4].

Financial Projections

Given the stable demand and competitive landscape, the financial trajectory for bismuth subsalicylate, metronidazole, and tetracycline hydrochloride is expected to remain steady.

  • Revenue Stability: The combination is likely to maintain its revenue stream due to its established efficacy and ongoing demand for H. pylori treatments.
  • Market Share: While generic competition may erode some market share, the branded version is expected to retain a significant portion of the market due to its reputation and clinical evidence.
  • Growth Opportunities: Emerging markets and increasing awareness of gastrointestinal health are expected to drive growth in the coming years.

Key Takeaways

  • The combination of bismuth subsalicylate, metronidazole, and tetracycline hydrochloride is a key treatment for H. pylori infections and duodenal ulcer disease.
  • The market is driven by the high prevalence of H. pylori infections and the need for effective treatments.
  • Regulatory environment, generic competition, and safety concerns are critical factors influencing the financial trajectory.
  • Emerging markets and advances in diagnostic techniques present growth opportunities.

FAQs

Q: What is the primary indication for bismuth subsalicylate, metronidazole, and tetracycline hydrochloride?

A: The primary indication is for the eradication of Helicobacter pylori in patients with active duodenal ulcers or a history of duodenal ulcer disease within the past five years[2][3][4].

Q: What are the common side effects of this drug combination?

A: Common side effects include darkening of the tongue and stool, weakness, diarrhea, constipation, and metallic taste in the mouth. More serious reactions like Stevens-Johnson syndrome can also occur[3][4].

Q: How does the combination of bismuth subsalicylate, metronidazole, and tetracycline hydrochloride work?

A: The combination works by preventing the growth and spread of H. pylori bacteria, with bismuth subsalicylate also providing anti-inflammatory and cytoprotective effects[1][2][4].

Q: What are the potential interactions with other medications?

A: This combination can interact with various medications, including antacids, aspirin, and omeprazole. Patients should discuss all current medications with their healthcare provider before starting treatment[3][4].

Q: Is this drug combination available in generic form?

A: Yes, generic versions of this combination are available, which can impact the market share of the branded version but also make the treatment more accessible and affordable[2][3].

Sources

  1. DrugBank: Bismuth subsalicylate: Uses, Interactions, Mechanism of Action.
  2. Drugs.com: Bismuth, Metronidazole and Tetracycline Capsules.
  3. MedlinePlus: Bismuth, Metronidazole, and Tetracycline.
  4. HealthLink BC: Bismuth Subsalicylate/Metronidazole/Tetracycline - Oral.

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