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ESKATA

NDA

HYDROGEN PEROXIDE | N209305 | ACLARIS THERAPEUTICS INC

1 strength5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Active (5)Today

2027

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2031

2032

2033

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2035

Today

Jul. 4, 2035

Apr. 21, 2035

Apr. 21, 2035

Apr. 21, 2035

Apr. 21, 2035

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov — 1 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effect of Bleaching Regimen With Different Activation Modes on Color Stability, Surface Roughness, Tooth Sensitivity and Patient Satisfaction NCT07493941	N/A	By Invitation	Tanta University	45	2026-01-01 → 2026-07-03
Comparing Two Agents Used to Stop Bleeding During Tonsil Removal Surgery: Adrenaline Versus Hydrogen Peroxide NCT07675278	N/A	Completed	Rawalpindi Medical College	64	2024-02-01 → 2025-01-31

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

API Supply Chain0 active DMFs3 inactive

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

PARKE DAVIS AND COInactiveHYDROGEN PEROXIDE SOLUTION 3%

DMF 18671972

FMC CORP HYDROGEN PEROXIDE DIVInactiveHYDROGEN PEROXIDE

DMF 156502001

PEROXYCHEM LLCInactiveHYDROGEN PEROXIDE 50% API GRADE

DMF 287262014

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Feb 20, 2019	SUPPL -1	View Letter (PDF)
Dec 15, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40%

RLD

5 patents0 exclusivities▴

SOLUTION;TOPICAL | Approved: Dec 14, 2017

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9675639	Jul 4, 2035	—	—	Yes		—
9980983	Apr 21, 2035	—	—	—		—
10098910	Apr 21, 2035	—	—	Yes		—
10493103	Apr 21, 2035	—	—	Yes	—	—
10729720	Apr 21, 2035	—	—	Yes	—	—