NDAORALTABLET
Approved
May 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
2/8 — Basic
Drug data last refreshed 7h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TINDAMAX (tinidazole) is an oral nitroimidazole antimicrobial approved in 2004 for parasitic and protozoal infections. It functions as a broad-spectrum antimicrobial agent effective against anaerobic bacteria and select protozoans. The drug is administered orally in tablet form for systemic infections.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); expect resource reallocation from brand team toward line extensions or next-generation assets.
Mechanism of Action
Pharmacologic Class:
Nitroimidazole Antimicrobial
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
"Sexual Health Assessment of TinidaZole Against M. Genitalium (SHAZAM)"
Started Jul 2025
40 enrolled
Mycoplasma GenitaliumNon-gonococcal Urethritis (NGU)
Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study
Started Oct 2007
37 enrolled
Bacterial Vaginosis
NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole)
Started Nov 2006
305 enrolled
Urethritis
Treatment of Bacterial Vaginosis With Oral Tinidazole
Started Jan 2005
200 enrolled
Bacterial Vaginosis
Treatment of Bacterial Vaginosis (BV) With Tinidazole
Started Nov 2004
593 enrolled
Bacterial Vaginosis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.