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TACLONEX

NDA

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE | N021852 | LEO PHARMA AS

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
LEO Pharma, Inc. (Covington & Burling LLP) - Citizen Petition FDA-2011-P-0565 · 3 docket documents LEO Pharma, Inc. filed this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refrain from approving any abbreviated new drug application for Taclonex Ointment or Taclonex Scalp Topical Suspension (calcipotriene 0.005% and betamethasone dipropi	505(q)	2011-08-15	Denied	—

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

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.

Drug Pricing (NADAC)

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

Highest NADAC/Unit

$2.35

per gm

Lowest NADAC/Unit

$1.59

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
66993093861CALCIPOTRIENE-BETAMETHASONE DP 0.005%-0.064% OINTMENT	$2.35	GM	Generic	—	2026-06-17
66993093865CALCIPOTRIENE-BETAMETHASONE DP 0.005%-0.064% OINTMENT	$1.59	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

$52.11

Highest Price

$349.11

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
66993-0938-61BETAMETHASONE DIPROPIONATE 0.064%/CALCIPOTRIE	$214.16	FSS	Prasco, LLC	06/30/2026
66993-0938-61BETAMETHASONE DIPROPIONATE 0.064%/CALCIPOTRIE	$52.11	Big4	Prasco, LLC	06/30/2026
66993-0938-65BETAMETHASONE DIPROPIONATE 0.064%/CALCIPOTRIE	$349.11	FSS	Prasco, LLC	06/30/2026
66993-0938-65BETAMETHASONE DIPROPIONATE 0.064%/CALCIPOTRIE	$102.53	Big4	Prasco, LLC	06/30/2026

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

Medicare Part D Spending

CMS annual spending data for Taclonex (2024)

Total Spending

$410K

Total Claims

202

Beneficiaries

Avg Cost/Unit

$21.08

Spending Trend

$5.9M(2019)→$2.2M(2020)→$1.1M(2021)→$652K(2022)→$665K(2023)→$410K(2024)

YoY Change:+2.7%

5yr CAGR:+4.1%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Dec 31, 2018	SUPPL -20	View Letter (PDF)
Dec 30, 2014	SUPPL -15	View Letter (PDF)
Jul 29, 2014	SUPPL -16	View Letter (PDF)
Dec 4, 2012	SUPPL -12	View Letter (PDF)
Apr 2, 2010	SUPPL -6	View Letter (PDF)
Oct 4, 2007	SUPPL -2	View Letter (PDF)
Jan 20, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.064%;0.005%

RLDAB

0 patents0 exclusivities▴

OINTMENT;TOPICAL | Approved: Jan 9, 2006

No patent or exclusivity listings for this strength.