Viewing data from:

DESOWEN

NDA

DESONIDE | N019048 | GALDERMA LABORATORIES LP

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

10 trials from ClinicalTrials.gov — 1 recruiting, 7 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Alternation in the Human Microbiome With Commonly Used Topical Medications NCT03437005	Phase 1	Recruiting	University of California, Davis	24	2013-01-28 → 2026-09-28
8-Week Atopic Dermatitis (AD) Treatment Study NCT03386032	Phase 3	Completed	Procter and Gamble	65	2017-11-27 → 2018-08-18
Evaluation of the Vasoconstriction Properties of MC2-01 Cream NCT03758365	Phase 1	Completed	MC2 Therapeutics	36	2018-11-05 → 2018-11-23
Efficacy and Tolerability of New Topical Formulations in Subjects With Atopic Dermatitis NCT02732314	Phase 4	Completed	Procter & Gamble Beauty	53	2016-03 → 2016-06
Efficacy of Desonide (Desonatetm) Gel 0.05% in Younger and Older Subjects With Atopic Dermatitis NCT00690833	Phase 4	Completed	Wake Forest University	41	2007-08 → 2009-11
Efficacy Emollient on Xerosis in Children With Atopic Dermatitis NCT01467362	Phase 3	Completed	Pierre Fabre Medicament	251	2011-11 → 2012-05
Clinical Trial of 4% Niacinamide Versus 0.05% Desonide for the Treatment of Axillar Hyperpigmentation NCT01542138	Phase 4	Completed	Universidad Autonoma de San Luis Potosí	28	2011-07 → 2012-11
Comparison of the Efficacy and Safety of Two Topical Creams for Pediatric Atopic Dermatitis NCT00828412	Phase 4	Completed	Promius Pharma, LLC	100	2009-03 → 2009-08
Skin Effects of a Topical Amino Acid Moisturizing Cream and Desonide in Atopic Dermatitis NCT02286700	Phase 3	UNKNOWN	NeoStrata Company, Inc.	42	2014-11 → 2015-03
Proton Pump Inhibitors Use in Patients With Psoriasis NCT02624544	Phase 4	Withdrawn	EMS	—	2016-01 → 2016-12

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$0.2562

per gm

Lowest NADAC/Unit

$0.1887

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00472080415DESONIDE 0.05% CREAM	$0.2562	GM	Generic	—	2026-06-17
00472080460DESONIDE 0.05% CREAM	$0.1887	GM	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 | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$4.47

Highest Price

$164.29

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00472-0804-15DESONIDE 0.05% CREAM,TOP	$41.58	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
00472-0804-15DESONIDE 0.05% CREAM,TOP	$4.47	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026
00472-0804-60DESONIDE 0.05% CREAM,TOP	$164.29	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
00472-0804-60DESONIDE 0.05% CREAM,TOP	$14.34	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026

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

API Supply Chain4 active DMFs6 inactive

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

TAPI NL BVDESONIDE

DMF 44201982

FARMABIOS SPADESONIDE DRUG SUBSTANCE

DMF 195742006

AARTI PHARMALABS LTDDESONIDE

DMF 229632009

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTDDESONIDE

DMF 384152026

LINSON LTDInactiveDESONIDE

DMF 16711971

ANTIBIOTICOS SPAInactiveDESONIDE, BULK, NON-STERILE, NON-MICRONIZED & MICRONIZED

DMF 31001978

ASPEN OSS BVInactiveDESONIDE

DMF 39391980

ER SQUIBB AND SONS INCInactiveDESONIDE

DMF 40081980

NITA PHARMACEUTICAL LTDInactiveDESONIDE (PREDNACINOLONE 16,17 ACETONIDE

DMF 54761984

NEWCHEM SPAInactiveDESONIDE MICRONIZED

DMF 227492009

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

Products (1)

#001 — 0.05%

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Dec 14, 1984

No patent or exclusivity listings for this strength.