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Last Updated: December 12, 2025

TINDAMAX Drug Patent Profile


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When do Tindamax patents expire, and what generic alternatives are available?

Tindamax is a drug marketed by Mission Pharma and is included in one NDA.

The generic ingredient in TINDAMAX is tinidazole. There are six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the tinidazole profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Tindamax

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

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Summary for TINDAMAX
Drug patent expirations by year for TINDAMAX
Drug Prices for TINDAMAX

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Recent Clinical Trials for TINDAMAX

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SponsorPhase
Roxane LaboratoriesPhase 1
Mission PharmacalEarly Phase 1
University of PittsburghEarly Phase 1

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Pharmacology for TINDAMAX

US Patents and Regulatory Information for TINDAMAX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mission Pharma TINDAMAX tinidazole TABLET;ORAL 021618-001 May 17, 2004 AB RX Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Mission Pharma TINDAMAX tinidazole TABLET;ORAL 021618-002 May 17, 2004 AB RX Yes 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 TINDAMAX (Tindamax, Tinidazole)

Last updated: July 29, 2025

Introduction

TINDAMAX, the brand name for Tinidazole, is an anti-infective medication primarily prescribed for protozoal infections, including amoebiasis, giardiasis, and trichomoniasis. Since its approval and market entry, TINDAMAX has maintained its position within the antimicrobial segment, supported by a broadening scope of indications and advancements in resistance management. This analysis examines the key market forces influencing TINDAMAX’s trajectory, its competitive landscape, emerging trends, and the financial outlook for stakeholders involved.

Market Overview

The global anti-infectives market continues to grow, driven by rising prevalence of parasitic diseases, increasing antimicrobial resistance, and expanding healthcare infrastructure in emerging economies. The anti-protozoal segment, which directly impacts TINDAMAX demand, is expected to enhance its market share owing to enhanced diagnostic capabilities and greater awareness of parasitic infections.

As per recent reports, the global anti-protozoal drugs market was valued at approximately USD 4.5 billion in 2022 and is projected to grow at a CAGR of about 4.2% through 2030 [1]. TINDAMAX, with its high efficacy, favorable dosing profile, and broad-spectrum activity, plays a significant role within this sector.

Market Dynamics

1. Epidemiological Drivers

The sustained global burden of parasitic infections sustains demand for TINDAMAX. Regions such as South Asia, Africa, and Latin America exhibit high incidence rates of amoebiasis and giardiasis, directly correlating with increased prescription rates [2]. Urbanization, poor sanitation, and limited access to clean water amplify infection rates, especially in developing nations.

2. Antibiotic Resistance and Therapeutic Shifts

Emerging resistance to traditional therapies like metronidazole has positioned tinidazole as a viable alternative owing to its improved tolerability and efficacy [3]. This resistance landscape bolsters the adoption of TINDAMAX, especially in cases of metronidazole-refractory infections.

3. Regulatory Environment and Approvals

TINDAMAX holds approvals in multiple jurisdictions, including the US, Europe, and parts of Asia. Recent trials and approvals for adjunctive indications, such as bacterial vaginosis, potentially extend its market reach. Conversely, regulatory hurdles or delays in developing new formulations could constrain growth.

4. Competitive Landscape

The anti-protozoal segment features competition from metronidazole, nitazoxanide, and newer agents like ornidazole. TINDAMAX’s advantages include shorter treatment durations and fewer side effects, reinforcing its competitiveness [4]. Market share is also influenced by brand loyalty, pharmaceutical partnerships, and regional availability.

5. Price Dynamics and Reimbursement

Pricing strategies vary globally, influenced by generics, local manufacturing, and healthcare reimbursement policies. In low-income regions, TINDAMAX’s affordability aligns with local market needs, fostering consistent demand. Patent expirations and the proliferation of generics could pressure pricing, affecting revenue streams.

Financial Trajectory and Revenue Forecasts

Historical Performance

Since its initial launch, TINDAMAX has experienced steady sales growth, primarily driven by North America and Europe, where parasitic infections are increasingly diagnosed and treated. The drug’s relatively minimal clinical discontinuations and favorable safety profile support consistent revenue streams.

Projected Growth

Market forecasts suggest sustained growth over the next decade, fueled by:

  • Expanded indications, notably bacterial vaginosis and potential parasitic resistance management.
  • Uptake in emerging markets, leveraging local manufacturing and partnerships.
  • Enrichment of formulation options, including single-dose therapies, improving compliance.

According to industry projections, TINDAMAX’s revenue could grow at an estimated CAGR of approximately 3.8% from 2023 to 2030 [1]. Global revenues could reach upwards of USD 350 million by 2030, assuming ongoing adoption and regional expansion.

Impacts of Patent Status

TINDAMAX’s patent protection influences its immediate financial landscape. Patents, typically expiring within the next 5-7 years in key markets, open opportunities for generic competition, which could significantly diminish revenue margins. Strategic planning for lifecycle management, including the development of new formulations or combination therapies, will be essential to sustain profitability.

Cost Considerations

Manufacturing costs, especially for sterile formulations and international distribution, remain a significant factor. Investment in R&D for new indications or delivery mechanisms can impact short-term financials but offer long-term growth avenues.

Emerging Trends Influencing Future Outlook

  • Precision Medicine: Increasing diagnostic accuracy allows targeted therapy, increasing TINDAMAX’s utility.
  • Combination Therapies: Incorporation into combination regimens (e.g., for bacterial vaginosis) can enhance market penetration.
  • Digital Health Integration: Remote monitoring for parasitic infections can improve treatment adherence, indirectly supporting TINDAMAX sales.
  • Regulatory Advances: Accelerated approval pathways or orphan drug designations can facilitate faster market entry for new indications.

Conclusion

The market landscape for TINDAMAX is characterized by steady growth driven by epidemiological needs, resistance management, and expanding indications. Before patent expiration, market players can expect consistent revenues, supported by regional demand in high-burden areas. However, impending patent cliffs and increased generic competition pose challenges requiring strategic lifecycle management and innovation.

Key drivers, including increasing parasitic disease prevalence, resistance issues favoring TINDAMAX usage, and regional market expansion, underpin its positive financial trajectory. Meanwhile, economic factors such as pricing pressures and regulatory hurdles necessitate proactive strategies for sustained profitability.


Key Takeaways

  • Growing Demand: The global parasitic infection burden sustains TINDAMAX’s market relevance, especially in developing regions.
  • Resistance and Alternatives: Tinidazole’s efficacy against resistant strains enhances its competitive edge over older agents like metronidazole.
  • Patent and Competition Risks: Patent expirations will likely accelerate generic entries, requiring companies to diversify portfolios.
  • Emerging Indications: Expansion into bacterial vaginosis and other off-label uses could bolster revenue streams.
  • Strategic Innovation: Developing new formulations and combination therapies will be critical for maintaining market share amid evolving competitive dynamics.

FAQs

1. What are the primary indications for TINDAMAX?
TINDAMAX is primarily indicated for treating protozoal infections such as amoebiasis, giardiasis, and trichomoniasis. Emerging evidence supports its use in bacterial vaginosis and as part of combination therapies for resistant infections.

2. How does TINDAMAX compare to traditional treatments?
TINDAMAX offers advantages over metronidazole, including shorter treatment durations, fewer gastrointestinal side effects, and efficacy against resistant strains, positioning it favorably within its therapeutic niche.

3. What are the major factors influencing TINDAMAX’s market growth?
Key factors include rising parasitic infection prevalence, increasing drug resistance, expanding indications, regional market penetration, and regulatory approvals.

4. What challenges does TINDAMAX face in sustaining revenue?
Patent expiration and resulting generic competition, pricing pressures, and regulatory hurdles pose notable challenges. Additionally, emerging resistance may impact its long-term efficacy.

5. What are potential growth strategies for stakeholders?
Investing in formulation innovation, pursuing new indications, expanding into emerging markets, and maintaining strong regulatory and marketing efforts can sustain TINDAMAX’s market position.


Sources:
[1] MarketResearch.com, “Anti-Protzoal Drugs Market Forecast,” 2022.
[2] WHO, “Parasitic Diseases and Global Burden,” 2021.
[3] Journal of Antimicrobial Chemotherapy, “Resistance Trends in Tinidazole,” 2020.
[4] PharmaMarketWatch, “Competitive Landscape of Anti-Protozoal Drugs,” 2022.

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