drug
METRONIDAZOLE
Marketedupdated 3mo agoby Saptalis Pharmaceuticals LLC
Approvedcommunity read0 votes
Small molecule drug with a maximum clinical stage of Approval (across all indications), with 13 approved and 42 investigational indications.
indications
investigational
COPD
all catalysts(36)
approval · 36
Jul 16, 1986
approval
METRONIDAZOLE — FDA approval
METRONIDAZOLE
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Nov 3, 1989
approval
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Mar 28, 1991
approval
METRONIDAZOLE — FDA approval
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Jun 3, 1991
approval
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Jan 12, 1994
approval
METRONIDAZOLE — FDA approval
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Jun 22, 1995
approval
METRONIDAZOLE — FDA approval
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Nov 15, 1995
approval
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May 22, 1996
approval
METRONIDAZOLE — FDA approval
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Feb 24, 1997
approval
METRONIDAZOLE — FDA approval
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May 21, 1997
approval
METRONIDAZOLE — FDA approval
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Sep 26, 1997
approval
METRONIDAZOLE — FDA approval
METRONIDAZOLE
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Sep 26, 1997
approval
METRONIDAZOLE — FDA approval
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Dec 5, 1997
approval
METRONIDAZOLE — FDA approval
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May 16, 2000
approval
METRONIDAZOLE — FDA approval
METRONIDAZOLE
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May 16, 2000
approval
METRONIDAZOLE — FDA approval
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May 2, 2001
approval
METRONIDAZOLE — FDA approval
METRONIDAZOLE
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Sep 17, 2001
approval
METRONIDAZOLE — FDA approval
METRONIDAZOLE
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Sep 17, 2001
approval
METRONIDAZOLE — FDA approval
METRONIDAZOLE
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Jul 29, 2002
approval
METRONIDAZOLE — FDA approval
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Dec 13, 2002
approval
METRONIDAZOLE — FDA approval
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Mar 28, 2005
approval
METRONIDAZOLE — FDA approval
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Aug 15, 2005
approval
METRONIDAZOLE — FDA approval
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Mar 28, 2012
approval
METRONIDAZOLE — FDA approval
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Feb 19, 2016
approval
METRONIDAZOLE — FDA approval
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Nov 5, 2019
approval
METRONIDAZOLE — FDA approval
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Nov 5, 2019
approval
METRONIDAZOLE — FDA approval
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Aug 30, 2021
approval
METRONIDAZOLE — FDA approval
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Sep 3, 2021
approval
METRONIDAZOLE — FDA approval
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Jul 6, 2022
approval
METRONIDAZOLE — FDA approval
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Jan 5, 2024
approval
METRONIDAZOLE — FDA approval
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Jul 8, 2024
approval
METRONIDAZOLE — FDA approval
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Feb 13, 2026
approval
METRONIDAZOLE — FDA approval
METRONIDAZOLE
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Feb 17, 2026
approval
METRONIDAZOLE — FDA approval
METRONIDAZOLE
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Feb 17, 2026
approval
METRONIDAZOLE — FDA approval
METRONIDAZOLE
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Mar 2, 2026
approval
METRONIDAZOLE — FDA approval
METRONIDAZOLE
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Mar 10, 2026
approval
METRONIDAZOLE — FDA approval
METRONIDAZOLE
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Trials studying METRONIDAZOLE
- phase2Chlorhexidine and/or Metronidazole Plus FB301 Pre-treatment Trial
- phase2Live Double Combined Lactobacillus Capsule for Vaginal Use（IIa）
- phase1Study of Metronidazole Delayed-Release Capsules in Comparison With Immediate-Release Tablets (Flagyl) for Safety and Pharmacokinetics
- phase1A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Metronidazole Alone or in Combination.
- phase2Pharmacokinetic and Safety Study of Metronidazole Oral Suspension in Pediatric Patients With Anaerobic Bacterial Infection
- phase3Efficacy of an Adapted Antibiotherapy in Hurley Stage 2 Hidradenitis Suppurativa Patients
- phase2Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD)
- phase4Comparison of Dequalinium Chloride (Fluomizin) vs Oral Metronidazole for the Treatment of Bacterial Vaginosis
Patent cliff
source: FDA Orange Bookfirst barrier falls
Feb 2, 2028
~1.5 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (9)
- Oct 4, 2039formulationUS 11541035
- Jan 16, 2039formulationUS 12257236
- Jun 28, 2032formulationUS 10238634
- Jun 28, 2032formulationUS 10596155
- Jun 28, 2032method-of-use (U-1664)US 8946276
- Jun 28, 2032method-of-use (U-1664)US 9198858
- Jun 27, 2028method-of-use (U-1682)US 86586781.9y
- Feb 19, 2028formulationUS 78930971.5y
- Feb 2, 2028formulationUS 88777921.5y
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