TINIDAZOLE - Generic Drug Details

What are the generic sources for tinidazole and what is the scope of patent protection?

Tinidazole is the generic ingredient in two branded drugs marketed by Mission Pharma, Chartwell Rx, Edenbridge Pharms, Hikma, and Thinq Pharm-cro Pvt, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for tinidazole. Seven suppliers are listed for this compound.

Summary for TINIDAZOLE

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	40
Patent Applications:	6,505
Drug Prices:	Drug price trends for TINIDAZOLE
What excipients (inactive ingredients) are in TINIDAZOLE?	TINIDAZOLE excipients list
DailyMed Link:	TINIDAZOLE at DailyMed

See drug prices for TINIDAZOLE

See drug sales revenues for TINIDAZOLE

Recent Clinical Trials for TINIDAZOLE

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

Sponsor	Phase
Shangrong Fan	N/A
Exeltis Turkey	Phase 1
Monitor CRO	Phase 1

See all TINIDAZOLE clinical trials

Pharmacology for TINIDAZOLE

Drug Class

Nitroimidazole Antimicrobial

Medical Subject Heading (MeSH) Categories for TINIDAZOLE

Alkylating Agents

Antitrichomonal Agents

Anatomical Therapeutic Chemical (ATC) Classes for TINIDAZOLE

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

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

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
Edenbridge Pharms	TINIDAZOLE	tinidazole	TABLET;ORAL	203808-002	Aug 4, 2015	AB	RX	No	No
Mission Pharma	TINDAMAX	tinidazole	TABLET;ORAL	021618-002	May 17, 2004	AB	RX	Yes	Yes
Chartwell Rx	TINIDAZOLE	tinidazole	TABLET;ORAL	202044-001	Apr 30, 2012	AB	RX	No	No
Mission Pharma	TINDAMAX	tinidazole	TABLET;ORAL	021618-001	May 17, 2004	AB	RX	Yes	No
Thinq Pharm-cro Pvt	TINIDAZOLE	tinidazole	TABLET;ORAL	202489-001	Oct 9, 2013	AB	RX	No	No
Thinq Pharm-cro Pvt	TINIDAZOLE	tinidazole	TABLET;ORAL	202489-002	Oct 9, 2013	AB	RX	No	No
Edenbridge Pharms	TINIDAZOLE	tinidazole	TABLET;ORAL	203808-001	Aug 4, 2015	AB	RX	No	No

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