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CLOBEX

NDA

CLOBETASOL PROPIONATE | N021644 | GALDERMA LABORATORIES 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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Galderma Laboratories, L.P. et al v. Perrigo Co et al 4:2010cv00584 2 patentsANDA 090974clobetasol propionate	N.D. Tex.	2010-08-17	Terminated 2010-12-08	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

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.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$0.2333

per ml

Lowest NADAC/Unit

$0.2333

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
68308066404CLOBETASOL 0.05% SHAMPOO	$0.2333	ML	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 3 NDCs (2 FSS, 1 Big4)

Lowest Price

$3.39

Highest Price

$79.15

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00299-3847-04CLOBEX 0.05% SHAMPOO	$79.15	FSS	Galderma Laboratories LP	03/31/2026
00299-3847-04CLOBEX 0.05% SHAMPOO	$79.15	Big4	Galderma Laboratories LP	03/31/2026
68308-0664-04CLOBETASOL PROPIONATE 0.05% SHAMPOO,TOP	$3.39	FSS	Mayne Pharma Commercial LLC	07/14/2030

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

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

3 letters from Drugs@FDA

Date	Submission	Document
Dec 3, 2012	SUPPL -3	View Letter (PDF)
Aug 20, 2012	SUPPL -2	View Letter (PDF)
Feb 27, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.05%

RLDAB

0 patents0 exclusivities▴

SHAMPOO;TOPICAL | Approved: Feb 5, 2004

No patent or exclusivity listings for this strength.