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EXTRA-STRENGTH AIM

NDA

SODIUM MONOFLUOROPHOSPHATE | N019518 | CHESEBROUGH PONDS INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Colgate-Palmolive Company FDA-1981-N-0015 · 46 docket documents Colgate-Palmolive Company filed this citizen petition under Section 505 of the Federal Food, Drug, and Cosmetic Act requesting that FDA permit marketing of an over-the-counter dentifrice toothpaste containing Sodium Monofluorophosphate 1.14%, Potassium Nitrate 5%, and Zinc Citrate 2% for anticaries,	Other	2012-05-18	Withdrawn	Colgate-Palmolive Company

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

30 trials from ClinicalTrials.gov, 29 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity NCT02832375	Phase 3	Completed	GlaxoSmithKline	242	2016-03-01 → 2016-05-12
Investigation of Dental Plaque and Gingival Index NCT00759031	Phase 3	Completed	Colgate Palmolive	19	2008-02 → 2008-03
Exploratory Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity NCT01831817	Phase 2	Completed	GlaxoSmithKline	140	2013-01 → 2013-05
Effect of Toothpaste on the Reduction of Plaque and Inflammation NCT02552589	N/A	Completed	Technische Universität Dresden	241	2015-09 → 2016-02
Compare Anti-inflammatory Dentifrices NCT00762528	Phase 4	Completed	Colgate Palmolive	49	2009-02 → 2010-02
Evaluate Inflammation Caused by Gingivitis in Adults NCT00941668	Phase 4	Completed	Colgate Palmolive	49	2007-01 → 2008-08
The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity (DH)NCT02924350	N/A	Completed	GlaxoSmithKline	205	2016-11-07 → 2017-03-17
Exploratory Study to Evaluate an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity NCT01691560	Phase 2	Completed	GlaxoSmithKline	140	2012-08 → 2012-11
Dentine Tubule Occlusion Assessment in a Modified in Situ Model NCT02768194	N/A	Completed	GlaxoSmithKline	26	2016-07-06 → 2016-09-21
Study to Investigate the Stain Control of Two Stannous Fluoride Dentifrices NCT03160703	N/A	Completed	GlaxoSmithKline	220	2017-07-10 → 2017-08-25

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain2 active DMFs2 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

TIANJIN YAGUANG HIGH TECH DEVELOPMENT COSODIUM MONOFLUOROPHOSPHATE

DMF 228942009

WENDENG JINYE INDUSTRIAL CO LTDSODIUM MONOFLUOROPHOSPHATE

DMF 333542018

OZARK MAHONING COInactiveSODIUM MONOFLUOROPHOSPHATE

DMF 5451963

FOREST LABORATORIES INCInactiveSODIUM MONOFLUOROPHOSPHATE 76 MG. C.R. TABLETS

DMF 71191987

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

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#001 — 1.2%

0 patents0 exclusivities▴

PASTE;DENTAL | Approved: Jun 3, 1987

No patent or exclusivity listings for this strength.

#002 — 1.2%

0 patents0 exclusivities▾

GEL;DENTAL | Approved: Aug 6, 1986