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TEMOVATE E

NDA

CLOBETASOL PROPIONATE | N020340 | FOUGERA PHARMACEUTICALS 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

82 trials from ClinicalTrials.gov — 4 recruiting, 2 active, 61 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib NCT06120140	Phase 2	Active	Janssen Research & Development, LLC	305	2024-02-16 → 2030-06-30
Efficacy of Topical Treatment With Clobetasol in Symptomatic Oral Lichen Planus.NCT04364555	Phase 2/3	Active	Malmö University	90	2020-05-18 → 2025-12
Efficacy of Clobetasol Vs Intralesional Triamcinolone in Lichen Planus Treatment NCT07666620	Phase 4	Not Yet Recruiting	Noor Aziz	50	2026-10-01 → 2027-04-30
Early Intervention in Plaque Psoriasis: is Bimekizumab Able to Delay Chronic Inflammation?NCT06742333	Phase 2	Recruiting	Centre Hospitalier Universitaire de Nice	40	2025-07-22 → 2029-01-01
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
Targeted Investigation of Microbiome 2 Treat Atopic Dermatitis (TIME-2)NCT06504160	Phase 1	Recruiting	National Institute of Allergy and Infectious Diseases (NIAID)	86	2025-05-22 → 2027-02-05
Treatment of Hypertrophic Scars Using Fractional Laser and Fractional Laser-assisted Topical Corticosteroid Delivery NCT02487212	Phase 4	Completed	Mahidol University	24	2014-04 → 2015-05
Impact of PDT and Topical Corticosteroids on Taste Perception and Salivary Oxidative Stress Markers in Patients With OLP NCT07536737	N/A	Completed	Medical University of Bialystok	65	2021-09-30 → 2023-07-10
A Trial That Compound Clobetasol Propionate Ointment Treats Patients With Mild to Moderate Psoriasis Vulgaris.NCT02733874	Phase 4	Completed	First Hospital of China Medical University	240	2015-04
A Clinical Trial to Compare Topical Agents in Adults With Mild to Moderate Atopic Dermatitis (AD)NCT02376049	Phase 1	Completed	LEO Pharma	30	2015-02 → 2015-07

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 PRIVATE 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

2 letters from Drugs@FDA

Date	Submission	Document
Nov 16, 2012	SUPPL -7	View Letter (PDF)
Apr 18, 2003	SUPPL -6	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: Jun 17, 1994

No patent or exclusivity listings for this strength.