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Last Updated: December 27, 2024

RANITIDINE BISMUTH CITRATE - Generic Drug Details


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What are the generic sources for ranitidine bismuth citrate and what is the scope of freedom to operate?

Ranitidine bismuth citrate is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for RANITIDINE BISMUTH CITRATE
Recent Clinical Trials for RANITIDINE BISMUTH CITRATE

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

SponsorPhase
Alphacait, LLCPhase 2
Haining Health-Coming Biotech Co., Ltd.Phase 2
Federal University of São PauloPhase 4

See all RANITIDINE BISMUTH CITRATE clinical trials

US Patents and Regulatory Information for RANITIDINE BISMUTH CITRATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline TRITEC ranitidine bismuth citrate TABLET;ORAL 020559-001 Aug 8, 1996 DISCN No No ⤷  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

Expired US Patents for RANITIDINE BISMUTH CITRATE

RANITIDINE BISMUTH CITRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ranitidine Bismuth Citrate

Introduction

Ranitidine bismuth citrate (RBC) is a medication specifically designed to treat Helicobacter pylori (H. pylori) infections and associated duodenal ulcers. This article delves into the market dynamics, financial trajectory, and clinical significance of RBC.

Clinical Significance of Ranitidine Bismuth Citrate

RBC is a complex of ranitidine, bismuth, and citrate, leveraging the acid-suppressive actions of ranitidine and the antimicrobial and mucosal protective effects of bismuth to eradicate H. pylori infections. When combined with clarithromycin, RBC achieves high H. pylori eradication rates of 73-94% and duodenal ulcer healing rates of 73-89% in clinical trials[2][5].

Market Size and Projections

The global market for RBC was estimated to be around USD 500 million in 2023. Market projections indicate continued growth, driven by the increasing recognition of the relationship between H. pylori infections and gastroduodenal diseases. The market is expected to expand as more patients seek effective treatments for these conditions[4].

Key Market Dynamics

Trends

  • Increasing Awareness: Growing awareness of the link between H. pylori infections and gastroduodenal diseases is driving the demand for effective treatments like RBC.
  • Advancements in Treatment Regimens: Continuous research and development of new treatment regimens, including dual and triple therapies involving RBC, are enhancing its market position[5].

Drivers

  • Efficacy and Safety: RBC's high eradication rates and low adverse effect profile make it a preferred choice among clinicians and patients.
  • Regulatory Approvals: RBC, in combination with clarithromycin, is one of the approved treatment regimens for H. pylori infections in the US, which boosts its market credibility[2].

Challenges

  • Competition from Alternative Treatments: The market faces competition from other treatment regimens, such as those involving proton pump inhibitors, which can impact RBC's market share.
  • Recent Controversies: Although not directly related to RBC, the removal of ranitidine (a component of RBC) from the market due to contamination with N-nitrosodimethylamine (NDMA), a carcinogen, could potentially affect public perception and regulatory scrutiny[3].

Opportunities

  • Expanding Patient Base: The global prevalence of H. pylori infections offers a significant patient base, providing opportunities for market expansion.
  • Emerging Markets: Developing countries with high incidence rates of H. pylori infections present untapped markets for RBC[4].

Financial Trajectory

Revenue and Growth

The global market for RBC is projected to grow, driven by increasing demand and the expanding patient base. The estimated market size of USD 500 million in 2023 is expected to increase as more patients seek effective treatments for H. pylori infections and associated conditions[4].

Cost-Effectiveness

RBC, when compared to other treatment regimens like omeprazole plus clarithromycin, may offer a cost-effective alternative. Although it might be more expensive than some other options, its efficacy and lower adverse effect rates can justify the cost[2].

Market Strategies

Leading companies in the RBC market are focusing on key success strategies, including enhancing distribution networks, investing in research and development, and promoting the drug through various marketing channels. These strategies aim to maintain market share and drive growth[1].

Regulatory Environment

RBC, in combination with clarithromycin, is approved by the FDA for the treatment of duodenal ulcers associated with H. pylori infections. This regulatory approval is crucial for its market presence and credibility. However, any changes in regulatory policies or safety concerns could impact its financial trajectory[2].

Competitive Landscape

The market for H. pylori treatments is competitive, with various treatment regimens available. RBC competes with proton pump inhibitors and other antibiotics, but its unique combination of ranitidine and bismuth provides a distinct advantage in terms of efficacy and safety[5].

Future Outlook

As more patients are treated and other regimens continue to be tested, the role of RBC will continue to evolve. The drug's safety profile, efficacy, and cost-effectiveness position it well for continued market growth and dominance in the treatment of H. pylori infections and associated conditions.

Key Takeaways

  • High Efficacy: RBC achieves high H. pylori eradication and duodenal ulcer healing rates.
  • Market Growth: The global market for RBC is projected to grow, driven by increasing demand and awareness.
  • Cost-Effectiveness: RBC offers a cost-effective treatment option compared to some other regimens.
  • Regulatory Approval: FDA approval for RBC in combination with clarithromycin is a significant market driver.
  • Competitive Advantage: The unique combination of ranitidine and bismuth provides a competitive edge.

FAQs

Q: What is the primary use of ranitidine bismuth citrate?

A: Ranitidine bismuth citrate is primarily used to treat Helicobacter pylori (H. pylori) infections and associated duodenal ulcers.

Q: How effective is ranitidine bismuth citrate in eradicating H. pylori?

A: RBC, in combination with clarithromycin, achieves H. pylori eradication rates of 73-94% and duodenal ulcer healing rates of 73-89%[2].

Q: What are the key components of ranitidine bismuth citrate?

A: Each tablet of RBC contains 162 mg of ranitidine base, 128 mg of trivalent bismuth, and 110 mg of citrate[2].

Q: Is ranitidine bismuth citrate safe?

A: RBC is associated with very low rates of adverse effects and is considered safe for use in treating H. pylori infections[2].

Q: What is the projected market size for ranitidine bismuth citrate?

A: The global market for RBC was estimated to be around USD 500 million in 2023 and is projected to grow further[4].

Sources

  1. Ranitidine Bismuth Citrate Market Projections 2024: Industry Growth ... - Wicz.com
  2. Ranitidine bismuth citrate in the treatment of Helicobacter pylori ... - PubMed
  3. Oregon Drug Use Review / Pharmacy & Therapeutics Committee ... - ORPDL.org
  4. Ranitidine Bismuth Citrate (CAS 128345-62-0) Market Research ... - DataIntelo
  5. Ranitidine bismuth citrate - PubMed - PubMed

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