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ENSTILAR

NDA

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE | N207589 | LEO PHARMA AS

1 strength8 unique patents0 unique exclusivities

Patent Timeline

8 unique patents by expiration date

Active (8)TodayPED (+6 mo)

2027

2028

2029

2030

2031

2032

Today

Dec. 10, 2031

Jun. 10, 2031

Dec. 10, 2031

Jun. 10, 2031

Jun. 10, 2031

Jun. 10, 2031

Jun. 10, 2031

Jun. 10, 2031

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
LEO Pharma A/S et al v. Glenmark Pharmaceuticals Ltd. 1:2020cv01359	D. Del.	2020-10-07	Terminated 2022-04-25	—

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

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.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$21.83

per gm

Lowest NADAC/Unit

$21.83

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
50222030260ENSTILAR 0.005%-0.064% FOAM	$21.83	GM	Brand	—	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

$956.03

Highest Price

$2678.37

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
50222-0302-60ENSTILAR FOAM	$1339.20	FSS	LEO Pharma, Inc.	05/14/2028
50222-0302-60ENSTILAR FOAM	$956.03	Big4	LEO Pharma, Inc.	05/14/2028
50222-0302-66ENSTILAR FOAM	$2678.37	FSS	LEO Pharma, Inc.	05/14/2028
50222-0302-66ENSTILAR FOAM	$1912.04	Big4	LEO Pharma, Inc.	05/14/2028

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

Medicare Part D Spending

CMS annual spending data for Enstilar (2024)

Total Spending

$6.9M

Total Claims

4,017

Beneficiaries

1,839

Avg Cost/Unit

$21.56

Spending Trend

$5.8M(2019)→$6.7M(2020)→$8.3M(2021)→$8.3M(2022)→$8.1M(2023)→$6.9M(2024)

YoY Change:-4.0%

5yr CAGR:+3.5%

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
Aug 10, 2021	SUPPL -11	View Letter (PDF)
Oct 20, 2020	SUPPL -10	View Letter (PDF)
Jul 31, 2019	SUPPL -7	View Letter (PDF)
Jul 31, 2019	SUPPL -6	View Letter (PDF)
Jul 31, 2019	SUPPL -5	View Letter (PDF)
Mar 10, 2016	SUPPL -1	View Letter (PDF)
Oct 20, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.064%;0.005%

RLD

8 patents0 exclusivities▴

AEROSOL, FOAM;TOPICAL | Approved: Oct 16, 2015

Patents (8) · 4 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9119781	Jun 10, 2031PED: Dec 10, 2031	PED	—	Yes		—
9566286	Jun 10, 2031	—	—	Yes	—	—
10130640	Jun 10, 2031PED: Dec 10, 2031	PED	—	Yes	—	—
10617698	Jun 10, 2031	—	—	Yes	—	—
10660908	Jun 10, 2031	—	—	Yes		—
10682364	Jun 10, 2031	—	—	Yes	—	—
10688108	Jun 10, 2031	—	—	—		—
10716799	Jun 10, 2031	—	—	Yes	—	—