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WYNZORA

NDA

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE | N213422 | MC2 THERAPEUTICS LTD

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Expiring < 1yr (1)Active (2)Today

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

Today

10265265

Sep. 27, 2027

11696919

Mar. 18, 2039

12440499

Mar. 18, 2039

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

11 trials from ClinicalTrials.gov, 11 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris NCT00817219	Phase 2	Completed	LEO Pharma	33	2009-07 → 2011-12
Efficacy, Safety, Preference and Response Duration of Clobex® Spray and Taclonex® Ointment in Psoriasis NCT00437255	Phase 4	Completed	Galderma R&D	122	2006-08 → 2007-06
1404003_OpenPsori.PlaqueTest to Eval.Eff.of Diff.Comp. to Mapracorat NCT03399526	Phase 1	Completed	Bayer	24	2013-02-11 → 2013-05-31
To Evaluate the Therapeutic Equivalence and Safety in Treatment of Scalp Psoriasis NCT03880357	Phase 1	Completed	Sun Pharmaceutical Industries, Inc.	485	2018-10-22 → 2019-03-15
A Study Evaluating the Efficacy and Tolerability of Enstilar Foam in Patients With Nail Psoriasis NCT04227288	Phase 4	Completed	University of Alabama at Birmingham	6	2021-11-01 → 2023-10-31
Trial to Assess the Potency of SOR007 Ointment in a Psoriasis Plaque Test NCT03004339	Phase 1	Completed	DFB Soria, LLC	13	2016-08 → 2017-02-13
Adherence in Topical Treatment of Psoriasis NCT02858713	Phase 4	Completed	Odense University Hospital	134	2017-01-09 → 2017-08-29
The Effect of Enstilar Versus Vehicle on Target Lesions in Moderate Plaque Type Psoriasis Patients NCT03848871	Phase 4	Completed	Derm Research, PLLC	20	2017-12-12 → 2018-12-10
Efficacy and Safety of Enstilar Foam in Combination With Apremilast (Otezla) in Patients With Moderate Plaque Psoriasis NCT03441789	Phase 4	Completed	L.H. Kircik, M.D.	28	2017-09-18 → 2018-10-22
To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064%, in the Treatment of Scalp Psoriasis NCT03331523	Phase 3	Completed	Glenmark Pharmaceuticals Ltd. India	643	2017-10-20 → 2018-10-25

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

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$896.36

Highest Price

$896.36

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
73499-0001-01WYNZORA CREAM,TOP	$896.36	FSS	Mayne Pharma Commercial LLC	07/14/2030

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 21, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.064%;0.005%

RLD

3 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Jul 20, 2020

Patents (3) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10265265	Sep 27, 2027	—	—	Yes	—	—
11696919	Mar 18, 2039	—	—	Yes	—	—
12440499	Mar 18, 2039	—	—	Yes		—