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NDA

CLOBETASOL PROPIONATE | N019322 | FOUGERA PHARMACEUTICALS INC

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

3 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Encore Dermatology Inc FDA-2020-P-2212 · 52 docket documents Encore Dermatology, Inc., the holder of the NDA for Impoyz (clobetasol propionate) 0.025% topical cream for moderate to severe plaque psoriasis, filed a citizen petition under section 505(q) requesting that FDA refuse to approve Glenmark Pharmaceuticals Limited's ANDA 214191 for a generic version of	505(q)	2020-11-19	Open	Encore Dermatology Inc
Citizen Petition from Encore Dermatology, Inc. FDA-2020-P-1421 · 55 docket documents Encore Dermatology, Inc. filed this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refuse to approve Glenmark Pharmaceuticals' ANDA 214191 for a generic clobetasol propionate topical cream product and instead require Glenmark and similarly s	505(q)	2020-05-27	Denied	Encore Dermatology, Inc.
Citizen Petition from Paddock Laboratories FDA-2006-P-0014 · 11 docket documents Paddock Laboratories, Inc. submitted this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Clobetasol Propionate Foam, 0.05%, suitable for submission in an Abbreviated New Drug Application, with the proposed change being a dosage	Other	2008-05-13	Withdrawn	Paddock Laboratories

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

Clinical Trials

76 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 59 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy of Topical Treatment With Clobetasol in Symptomatic Oral Lichen Planus.NCT04364555	Phase 2/3	Active	Malmö University	90	2020-05-18 → 2025-12
Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study NCT04207931	Phase 4	Recruiting	Wake Forest University Health Sciences	250	2018-04-30 → 2027-03
A Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis NCT02635204	Phase 3	Completed	Promius Pharma, LLC	267	2015-12 → 2016-07
Clobetasol Propionate Spray Versus Vehicle Spray for the Management of Moderate to Severe Plaque Psoriasis of the Scalp NCT00881868	Phase 4	Completed	Galderma R&D	81	2009-04 → 2009-12
BAY1003803 Formulation Comparison in Open Psoriasis Plaque Test NCT02940002	Phase 1	Completed	Bayer	23	2016-10-12 → 2017-03-17
A Study to Evaluate the Efficacy and Tolerability of Topical Therapies for the Condition of Plaque-Type Psoriasis NCT00852761	Phase 4	Completed	Stiefel, a GSK Company	34	2009-03 → 2009-08
Subject Reported Target-lesion Numeric Rating Scale Evaluation by Subjects With Plaque Psoriasis Treated With Clobex® (Clobetasol Propionate) Spray 0.05%NCT01893567	Phase 4	Completed	Galderma R&D	28	2013-07 → 2013-10
Comparison of Tacrolimus 0.1% and Clobetasol 0.05% in the Management of Symptomatic Oral Lichen Planus NCT02744378	Phase 2	Completed	University of Peradeniya	68	2014-06 → 2015-12
Evaluation of the Efficacy and Tolerability of Clobetasol Propionate Foam Compared to Vehicle Foam NCT00842153	Phase 4	Completed	Stiefel, a GSK Company	58	2007-11 → 2008-01
The Dose-response "Pilot" Study of Topically Delivered Clobetasol Propionate Lotion in Healthy Adult Subjects NCT00864240	Phase 1	Completed	Actavis Inc.	15	2005-10 → 2005-10

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

API Supply Chain9 active DMFs4 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVCLOBETASOL PROPIONATE

DMF 68141987

FARMABIOS SPACLOBETASOL PROPIONATE

DMF 83361989

SYMBIOTEC PHARMALAB LTDCLOBETASOL PROPIONATE USP

DMF 208212007

HALCYON LABS PRIVATE LTDCLOBETASOL PROPIONATE USP

DMF 212162008

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHDCLOBETASOL PROPIONATE

DMF 240152010

CURIA SPAIN SAUCLOBETASOL PROPIONATE MICRONIZED

DMF 261912012

ENVEE DRUGS PVT LTDCLOBETASOL PROPIONATE USP

DMF 307522016

RN LABORATORIES EUROPE BVCLOBETASOL PROPIONATE USP (21-CHLORO-9-FLUORO-11, 17-DIHYDROXY-16-METHYLPREGNA-1,4-DIENE3,20-DIONE 17-PROPIONATE)

DMF 344852020

NEWCHEM SPACLOBETASOL PROPIONATE

DMF 428922025

CESQUISA SAInactiveCLOBETASOL PROPIONATE

DMF 80961989

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveCLOBETASOL PROPIONATE

DMF 182022005

MAHIMA LIFE SCIENCES PRIVATE LTDInactiveCLOBETASOL PROPIONATE USP

DMF 226502008

GLAXOSMITHKLINE LLCInactiveCLOBETASOL PROPIONATE

DMF 254442012

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 18, 2003	SUPPL -18	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Dec 27, 1985

No patent or exclusivity listings for this strength.