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DOVONEX

NDA

CALCIPOTRIENE | N020611 | LEO PHARMACEUTICAL PRODUCTS LTD

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
LEO Pharma, Inc. - Citizen Petition FDA-2011-P-0593 · 3 docket documents LEO Pharma, Inc. filed this citizen petition concerning Dovonex Cream, a topical calcipotriene drug for treating plaque psoriasis, requesting that the FDA strengthen its calcium-monitoring requirements for generic versions of this product by requiring measurement of urinary calcium levels in additio	505(q)	2011-09-01	Denied	—
Lachman Consultant Services, Inc. - Citizen Petition FDA-2008-P-0435 · 4 docket documents Lachman Consultant Services, Inc., filed this petition requesting that the FDA determine whether Dovonex (calcipotriene) Ointment 0.005%, NDA 20-273 held by Leo Pharma, was voluntarily withdrawn from sale for safety or effectiveness reasons under 21 CFR 314.161 and 314.162, as the product no longer	505(q)	2008-07-30	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

35 trials from ClinicalTrials.gov — 1 recruiting, 29 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Intralesional 5-Fluorouracil (5FU), Topical Calcipotriene Treatment for SCC NCT03370406	Phase 1	Recruiting	Melissa Pugliano-Mauro	30	2018-08-03 → 2027-10-30
Safety, Tolerability And Efficacy Study Of Topical PF-06763809 In Subjects With Mild To Moderate Chronic Plaque Psoriasis NCT03469336	Phase 1	Completed	Pfizer	18	2018-04-24 → 2019-03-20
Efficacy and Safety of Calcipotriene/Betamethasone Gel/Ointment in Psoriasis NCT00279162	Phase 3	Completed	LEO Pharma	160	2005-12 → 2007-07
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
Evaluate Safety and Tolerability of Calcipotriene Foam 0.005% in Pediatric Subjects With Mild/Moderate Plaque Psoriasis NCT01582932	Phase 1	Completed	Mayne Pharma International Pty Ltd	36	2013-04 → 2018-08
Safety, Tolerability and Efficacy of SNA-120 for Treatment of Pruritus and Psoriasis in Subjects Treated With Calcipotriene NCT03448081	Phase 2	Completed	Sienna Biopharmaceuticals	73	2018-02-12 → 2018-12-10
1404003_OpenPsori.PlaqueTest to Eval.Eff.of Diff.Comp. to Mapracorat NCT03399526	Phase 1	Completed	Bayer	24	2013-02-11 → 2013-05-31
Role of Topical Treatments in the Modulation of Skin Microbiome in Psoriatic Skin NCT03584360	Phase 2	Completed	Centre Hospitalier Universitaire de Nice	30	2018-09-24 → 2019-03-07
LEO 80185 in the Treatment of Psoriasis Vulgaris on the Non-scalp Regions of the Body (Trunk and/or Limbs)NCT01188928	Phase 3	Completed	LEO Pharma	1,152	2010-09 → 2011-03

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

API Supply Chain9 active DMFs4 inactive

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

LEO PHARMA ASCALCIPOTRIENE HYDRATE DRUG SUBSTANCE

DMF 105141993

LEO PHARMA ASCALCIPOTRIENE CREAM

DMF 105151993

TAPI NL BVCALCIPOTRIENE USP

DMF 169582003

ALP PHARM BEIJING CO LTDCALCIPOTRIENE (CALCIPOTRIOL)

DMF 219432008

CERBIOS PHARMA SACALCIPOTRIENE ANHYDROUS

DMF 231032009

ALP PHARM BEIJING CO LTDCALCIPOTRIENE HYDRATE

DMF 272222013

CERBIOS PHARMA SACALCIPOTRIENE MONOHYDRATE

DMF 306152016

NANJING HERON PHARMACEUTICAL CO LTDCALCIPOTRIENE MONOHYDRATE

DMF 387432023

ANHUI HAOYUAN PHARMACEUTICAL CO LTDCALCIPOTRIENE

DMF 406922024

LEO PHARMA ASInactiveCALCIPOTRIENE DRUG SUBSTANCE

DMF 83081989

LEO PHARMA ASInactiveCALCIPOTRIENE OINTMENT

DMF 83121989

LEO PHARMA ASInactiveCALCIPOTRIENE SCALP SOLUTION

DMF 108391994

SAFC INCInactiveCALCIPOTRIENE

DMF 169282003

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Oct 4, 2007	SUPPL -7	View Letter (PDF)
May 2, 2005	SUPPL -6	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;TOPICAL | Approved: Mar 3, 1997

No patent or exclusivity listings for this strength.