Viewing data from:

VERDESO

NDA

DESONIDE | N021978 | GENUS LIFESCIENCES INC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

Today

8460641

Aug. 13, 2027

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
Delcor Asset Corporation et al v. Glenmark Pharmaceuticals Limited et al 1:2018cv00460	D. Del.	2018-03-26	Terminated 2019-01-11	—

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

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Proton Pump Inhibitors Use in Patients With Psoriasis NCT02624544	Phase 4	Withdrawn	EMS	—	2016-01 → 2016-12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.

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.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Mar 31, 2020	SUPPL -16	View Letter (PDF)
Apr 16, 2019	SUPPL -15	View Letter (PDF)
Apr 3, 2013	SUPPL -10	View Letter (PDF)
Aug 26, 2011	SUPPL -9	View Letter (PDF)
Apr 28, 2010	SUPPL -7	View Letter (PDF)
Sep 20, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.05%

RLD

1 patent0 exclusivities▴

AEROSOL, FOAM;TOPICAL | Approved: Sep 19, 2006

Patents (1) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8460641	Aug 13, 2027	—	—	Yes		—