Viewing data from:

EXELDERM

NDA

SULCONAZOLE NITRATE | N018737 | JOURNEY MEDICAL CORP

1 strength0 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Exelderm (2023)

Total Spending

$111K

Total Claims

188

Beneficiaries

130

Avg Cost/Unit

$13.64

Spending Trend

$49K(2022)→$111K(2023)

YoY Change:+2.0%

5yr CAGR:+2.0%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain1 active DMF

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

ERREGIERRE SPASULCONAZOLE NITRATE USP

DMF 149722000

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 8, 2003	SUPPL -3	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

RLD

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Feb 28, 1989

No patent or exclusivity listings for this strength.