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Last Updated: December 26, 2024

TINIDAZOLE Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Tinidazole

A generic version of TINIDAZOLE was approved as tinidazole by CHARTWELL RX on April 30th, 2012.

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US Patents and Regulatory Information for TINIDAZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chartwell Rx TINIDAZOLE tinidazole TABLET;ORAL 202044-001 Apr 30, 2012 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Thinq Pharm-cro Pvt TINIDAZOLE tinidazole TABLET;ORAL 202489-001 Oct 9, 2013 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Edenbridge Pharms TINIDAZOLE tinidazole TABLET;ORAL 203808-002 Aug 4, 2015 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Thinq Pharm-cro Pvt TINIDAZOLE tinidazole TABLET;ORAL 202489-002 Oct 9, 2013 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx TINIDAZOLE tinidazole TABLET;ORAL 202044-002 Apr 30, 2012 AB RX 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

TINIDAZOLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tinidazole

Introduction

Tinidazole, a nitroimidazole antibiotic, is widely used to treat various infections including trichomoniasis, giardiasis, amebiasis, and bacterial vaginosis. Understanding the market dynamics and financial trajectory of tinidazole is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Size and Growth

The global tinidazole tablet market is projected to grow at a moderate pace. The market size is expected to increase at a Compound Annual Growth Rate (CAGR) of 3 to 5 percent from its estimated valuation by 2031[4].

Segmentation and Regional Analysis

The tinidazole market can be segmented based on dosage, application, and region. The 250mg and 500mg dosages are the most common and have significant impacts on the market.

  • Dosage Segmentation: The 250mg and 500mg tablets are the primary dosage forms. These dosages are critical in treating various infections, and their demand influences market trends[1].
  • Regional Analysis: The market is analyzed at global, regional, and country levels. Regions such as North America, Europe, Asia-Pacific, and Latin America are key markets. The Asia-Pacific region is expected to show significant growth due to increasing healthcare needs and improving economic conditions[1].

Key Drivers and Opportunities

Several factors drive the growth of the tinidazole market:

  • Increasing Prevalence of Infections: The rising incidence of infections such as trichomoniasis, giardiasis, and amebiasis drives the demand for effective treatments like tinidazole[5].
  • Advancements in Healthcare: Improvements in healthcare infrastructure and access to medications in developing countries contribute to market growth.
  • Competitive Landscape: Multiple manufacturers, including Rising Pharma Holdings, Inc., REMEDYREPACK INC., and RedPharm Drug, Inc., offer tinidazole tablets, which increases competition and potentially drives down prices, making the drug more accessible[5].

Restraints and Challenges

Despite the growth potential, the market faces several challenges:

  • Regulatory Hurdles: Strict regulatory requirements and the need for continuous clinical trials can slow down market expansion.
  • Side Effects and Safety Concerns: Tinidazole, like other antibiotics, can have side effects, which may deter some patients and affect market growth[5].
  • Generic Competition: The presence of generic versions of tinidazole can reduce the market share of branded products and impact revenue.

Financial Performance

The financial performance of tinidazole is influenced by several factors:

  • Sales Revenue: The sales revenue of tinidazole is significant, with the average cumulative 9-quarter sales for antimicrobial drugs, including tinidazole, ranging from $42 million to $62 million, although this is lower compared to oncology drugs[2].
  • Development and Approval Costs: Tinidazole, as part of the antimicrobial drugs cohort, has relatively lower development and approval costs compared to other drug types. The average capitalized development and approval costs for antimicrobial drugs are approximately $1.508 billion, which is less than those for non-AM comparator and oncology drugs[2].

Pricing and Affordability

The pricing of tinidazole varies based on the manufacturer and region:

  • Unit Prices: The unit price for tinidazole tablets can range from $3.25 for a 250mg tablet to $9.02 for a 500mg tablet under different brand names[5].
  • Affordability: The availability of generic versions and competition among manufacturers help in keeping the prices affordable, making the drug accessible to a broader patient population.

Consumer Behavior and Market Trends

Consumer behavior plays a crucial role in shaping the market:

  • Patient Preferences: Patients often prefer medications with fewer side effects and better efficacy, which can influence the demand for tinidazole.
  • Physician Recommendations: Prescriptions by healthcare providers are a key driver of sales. The perceived effectiveness and safety of tinidazole among healthcare professionals can significantly impact market trends.

Technological and Clinical Trends

Advancements in technology and clinical practices also impact the market:

  • Clinical Trials and Research: Ongoing clinical trials and research on tinidazole and other antimicrobial drugs can lead to new indications and improved formulations, enhancing market growth.
  • Resistance and Efficacy: The rising concern of antibiotic resistance highlights the need for continuous innovation and development of effective antimicrobial agents like tinidazole.

Competitive Analysis

The competitive landscape of the tinidazole market is diverse:

  • Key Players: Companies such as Rising Pharma Holdings, Inc., REMEDYREPACK INC., and RedPharm Drug, Inc. are major players in the market. These companies compete based on pricing, product quality, and marketing strategies[5].
  • Market Share: The market share is distributed among various manufacturers, with branded and generic versions competing for dominance.

SWOT Analysis

A SWOT analysis provides a comprehensive view of the market:

  • Strengths: Effective treatment for various infections, moderate growth rate, and affordability.
  • Weaknesses: Side effects, regulatory challenges, and generic competition.
  • Opportunities: Increasing healthcare needs, advancements in healthcare infrastructure, and potential new indications.
  • Threats: Antibiotic resistance, stringent regulations, and economic fluctuations.

COVID-19 Impact

The COVID-19 pandemic has had a mixed impact on the tinidazole market:

  • Supply Chain Disruptions: The pandemic caused disruptions in the supply chain, affecting the availability of tinidazole in some regions.
  • Increased Demand: The pandemic also highlighted the importance of antimicrobial drugs, potentially increasing demand for tinidazole and other similar medications.

ESG and PESTEL Analysis

Environmental, Social, and Governance (ESG) factors, as well as Political, Economic, Social, Technological, Environmental, and Legal (PESTEL) analysis, are crucial for understanding the broader impact on the market:

  • ESG Analysis: The environmental impact of tinidazole production, social responsibility of manufacturers, and governance practices can influence investor decisions and market perception.
  • PESTEL Analysis: Political policies, economic conditions, social trends, technological advancements, environmental concerns, and legal frameworks all play significant roles in shaping the market dynamics[1].

Key Takeaways

  • The global tinidazole tablet market is expected to grow at a CAGR of 3 to 5 percent by 2031.
  • The 250mg and 500mg dosages are critical segments driving market growth.
  • Increasing prevalence of infections and advancements in healthcare are key drivers.
  • Regulatory challenges, side effects, and generic competition are significant restraints.
  • The financial performance is influenced by sales revenue, development costs, and pricing strategies.

FAQs

What are the primary uses of tinidazole?

Tinidazole is used to treat infections such as trichomoniasis, giardiasis, amebiasis, and bacterial vaginosis[5].

What is the expected CAGR of the tinidazole market?

The tinidazole market is expected to grow at a CAGR of 3 to 5 percent by 2031[4].

Who are the major players in the tinidazole market?

Major players include Rising Pharma Holdings, Inc., REMEDYREPACK INC., and RedPharm Drug, Inc.[5].

What are the key restraints facing the tinidazole market?

Key restraints include regulatory hurdles, side effects, and generic competition[5].

How has the COVID-19 pandemic impacted the tinidazole market?

The pandemic has caused supply chain disruptions but also highlighted the importance of antimicrobial drugs, potentially increasing demand[1].

References

  1. Global Tinidazole Tablet Market Report 2024 Edition - Cognitivemarketresearch.com
  2. Antimicrobial Drugs Market Returns Analysis - ASPE
  3. Mission Pharmacal Co. - Synapse.patsnap.com
  4. Global Tinidazole Tablet Market Size And Forecast - Marketresearchintellect.com
  5. Tinidazole: Uses, Interactions, Mechanism of Action - DrugBank Online

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