Viewing data from:

CORDRAN

NDA

FLURANDRENOLIDE | N016455 | ALMIRALL LLC

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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
IGI Laboratories Inc. - Citizen Petition FDA-2013-P-0113 · 4 docket documents IGI Laboratories Inc. filed this citizen petition on January 15, 2013, under 21 USC 355 and 21 CFR 314.93 and 314.161, requesting that the FDA determine whether Cordran flurandrenolide Ointment USP 0.05% (NDA 12-806, held by Aqua Pharmaceuticals) was voluntarily withdrawn from sale for reasons of sa	505(q)	2013-02-06	Denied	—
Citizen Petition from Scarguard Labs, LLC FDA-2009-P-0229 · 3 docket documents Scarguard Labs, LLC filed this citizen petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that Psoriafilm (flurandrenolide, 4 micrograms per square centimeter in a topical collodion base formulation) is suitable for consideration in an a	Other	2009-05-27	Withdrawn	Scarguard Labs, LLC

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$510.32

Highest Price

$510.32

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
16110-0587-80CORDRAN 4MCG/SQCM TAPE,80IN ROLL	$510.32	FSS	Almirall, LLC	05/14/2030
16110-0587-80CORDRAN 4MCG/SQCM TAPE,80IN ROLL	$510.32	Big4	Almirall, LLC	05/14/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain2 active DMFs2 inactive

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

FARMABIOS SPAFLURANDRENOLIDE

DMF 164922003

3M COFLURANDRENOLIDE DRUG-IN-ADHESIVE R-2813

DMF 387062024

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveFLURANDRENOLIDE

DMF 41071981

ANTIBIOTICOS SPAInactiveFLURANDRENOLIDE USP BULK FORM (NON-STERILE)

DMF 50631983

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

Products (1)

#001 — 0.004MG/SQ CM

RLD

0 patents0 exclusivities▴

TAPE;TOPICAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.