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CORDRAN

NDA

FLURANDRENOLIDE | N012806 | INA PHARMACEUTICS INC

4 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
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determine whether Cordran flurandrenolide Ointment USP 0.05% (NDA 12-806, held by Aqua Pharmaceuticals) was voluntarily withdrawn from sale for reasons of sa	505(q)	2013-02-06	Denied	—

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Cordran (2024)

Total Spending

$3.4M

Total Claims

3,293

Beneficiaries

1,781

Avg Cost/Unit

$796.61

Spending Trend

$3.1M(2020)→$3.9M(2021)→$3.5M(2022)→$3.4M(2023)→$3.4M(2024)

YoY Change:-1.0%

5yr CAGR:+2.3%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

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.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jun 14, 2013	SUPPL -36	View Letter (PDF)
Jul 17, 2002	SUPPL -28	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 0.05%

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#004 — 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

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

#002 — 0.05%

RLD

0 patents0 exclusivities▾

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

#003 — 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

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