Topical metronidazole — Competitive Intelligence Brief

Topical metronidazole (Topical metronidazole) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Nitroimidazole antimicrobial. Area: Dermatology.

marketed Nitroimidazole antimicrobial Bacterial DNA (via nitroimidazole reduction) Dermatology Small molecule

Target snapshot

Topical metronidazole (Topical metronidazole) — University of Toronto. Topical metronidazole reduces inflammation and bacterial overgrowth in skin conditions by disrupting microbial DNA and reducing pro-inflammatory cytokine production.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Topical metronidazole TARGET	Topical metronidazole	University of Toronto	marketed	Nitroimidazole antimicrobial	Bacterial DNA (via nitroimidazole reduction)
Fexinidazole	FEXINIDAZOLE	Sanofi	marketed	Nitroimidazole Antimicrobial [EPC]		2021-01-01
Solosec	SECNIDAZOLE	Evofem Inc	marketed	Nitroimidazole Antimicrobial [EPC]		2017-01-01
BISMUTH SUBCITRATE POTASSIUM	BISMUTH SUBCITRATE POTASSIUM		marketed	Nitroimidazole Antimicrobial [EPC]		2006-01-01
Pylera	BISMUTH SUBCITRATE		marketed	Nitroimidazole Antimicrobial [EPC]		2006-01-01
Tindamax	TINIDAZOLE	Mission Pharma	marketed	Nitroimidazole Antimicrobial [EPC]		2004-01-01
Metro I.V. In Plastic Container	METRONIDAZOLE	Baxter	marketed	Nitroimidazole Antimicrobial [EPC]		1963-01-01

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

• 2028-02-02 — Metro I.V. In Plastic Container · 8877792 · Formulation · US
• 2028-02-19 — Metro I.V. In Plastic Container · 7893097 · Formulation · US
• 2028-06-27 — Metro I.V. In Plastic Container · 8658678 · Method of Use · US
• 2032-06-28 — Metro I.V. In Plastic Container · 9198858 · Method of Use · US
• 2032-06-28 — Metro I.V. In Plastic Container · 8946276 · Method of Use · US
• 2032-06-28 — Metro I.V. In Plastic Container · 10238634 · Formulation · US
• 2032-06-28 — Metro I.V. In Plastic Container · 10596155 · Formulation · US
• 2039-01-16 — Metro I.V. In Plastic Container · 12257236 · Formulation · US
• 2039-10-04 — Metro I.V. In Plastic Container · 11541035 · Formulation · US

Sponsor landscape (Nitroimidazole antimicrobial class)

1. Galderma R&D · 2 drugs in this class
2. University of Guarulhos · 2 drugs in this class
3. Jinnah Postgraduate Medical Centre · 1 drug in this class
4. Peking University Shenzhen Hospital · 1 drug in this class
5. University of Toronto · 1 drug in this class