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Bifluorid 12 — Competitive Intelligence Brief
phase 3
Topical fluoride varnish
Tooth enamel hydroxyapatite
Dental/Preventive Medicine
Small molecule
Live · refreshed every 30 min
Target snapshot
Bifluorid 12 (Bifluorid 12) — Dow University of Health Sciences. Bifluorid 12 is a topical fluoride varnish that delivers high-concentration fluoride to tooth surfaces to prevent dental caries and remineralize early enamel lesions.
Comparator set (6 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| Bifluorid 12 TARGET | Bifluorid 12 | Dow University of Health Sciences | phase 3 | Topical fluoride varnish | Tooth enamel hydroxyapatite | |
| Sodium monofluorophosphate dentifrice | Sodium monofluorophosphate dentifrice | Procter and Gamble | marketed | Fluoride dentifrice | Tooth enamel hydroxyapatite; bacterial enolase | |
| Sodium Fluoride Dentifrice | Sodium Fluoride Dentifrice | Procter and Gamble | marketed | Fluoride topical agent | Tooth enamel hydroxyapatite; bacterial enolase | |
| Sodium monofluorophosphate toothpaste | Sodium monofluorophosphate toothpaste | Procter and Gamble | marketed | Fluoride toothpaste | Tooth enamel hydroxyapatite; bacterial enolase | |
| Sodium fluoride paste | Sodium fluoride paste | Procter and Gamble | marketed | Topical fluoride agent | Tooth enamel hydroxyapatite | |
| Fluoride toothpaste | Fluoride toothpaste | CareQuest Institute for Oral Health | marketed | Topical fluoride agent | Tooth enamel hydroxyapatite; oral bacterial glycolytic enzymes | |
| elmex® gelée | elmex® gelée | Gaba International AG | marketed | Topical fluoride agent | Tooth enamel hydroxyapatite; bacterial glycolytic enzymes |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
Sponsor landscape (Topical fluoride varnish class)
- Dow University of Health Sciences · 1 drug in this class
- University of Nebraska · 1 drug in this class
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Cite this brief
Drug Landscape (2026). Bifluorid 12 — Competitive Intelligence Brief. https://druglandscape.com/ci/bifluorid-12. Accessed 2026-05-14.
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