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TAZORAC

NDA

TAZAROTENE | N020600 | ALMIRALL LLC

2 strengths0 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

39 trials from ClinicalTrials.gov, 32 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Face NCT00489086	Phase 2	Completed	UCSF Benioff Children's Hospital Oakland	36	2004-07 → 2012-06
A Study to Evaluate the Irritation Potential of Tazarotene Foam on Skin in Healthy Volunteers NCT01112787	Phase 1	Completed	Stiefel, a GSK Company	39	2010-03-26 → 2010-04-26
A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris NCT02886715	Phase 3	Completed	Fougera Pharmaceuticals Inc.	1,110	2016-09-21 → 2017-05-31
A Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Common Facial Acne - W0260-301 NCT01017146	Phase 3	Completed	Stiefel, a GSK Company	744	2009-10 → 2010-11
Differin® Gel x12 Wks vs Tazorac® Cream x12 Wks vs Differin® x6 Wks Switched to Tazorac® x6 Wks for Treatment of Acne NCT00469755	Phase 4	Completed	Galderma R&D	302	2006-02 → 2006-09
Efficacy and Safety of Tazarotene Gel in Nail Psoriasis NCT02235480	Phase 2	Completed	Almirall, S.A.	66	2014-02 → 2015-05
A Study to Evaluate the Potential of Tazarotene Foam to Cause an Allergic Reaction When Applied to the Skin and Exposed to Light on Healthy Volunteers.NCT01119651	Phase 1	Completed	Stiefel, a GSK Company	59	2010-06-14 → 2010-06-26
Dose Range Study of CD5789 in Acne Vulgaris NCT01616654	Phase 2	Completed	Galderma R&D	304	2012-06-20 → 2014-06-12
Dapsone Gel 5% and Tazarotene Cream 0.1% Versus Tazarotene Cream 0.1% Monotherapy for Facial Acne Vulgaris NCT00834210	Phase 4	Completed	Allergan	171	2008-12 → 2009-09
A Study Comparing Tazarotene Cream 0.05% to TAZORAC® (Tazarotene) Cream 0.05% and Both to a Placebo Control in the Treatment of Plaque Psoriasis NCT02886702	Phase 3	Completed	Fougera Pharmaceuticals Inc.	855	2016-09-19 → 2017-08-02

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$346.57

Highest Price

$1227.21

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
16110-0833-30TAZORAC 0.05% GEL,TOP	$346.57	FSS	Almirall, LLC	05/14/2030
16110-0833-30TAZORAC 0.05% GEL,TOP	$346.57	Big4	Almirall, LLC	05/14/2030
16110-0042-10TAZORAC 0.1% GEL,TOP	$1227.21	Big4	Almirall, LLC	05/14/2030
16110-0042-10TAZORAC 0.1% GEL,TOP	$1227.21	FSS	Almirall, LLC	05/14/2030
16110-0042-30TAZORAC 0.1% GEL,TOP	$368.19	Big4	Almirall, LLC	05/14/2030
16110-0042-30TAZORAC 0.1% GEL,TOP	$368.19	FSS	Almirall, LLC	05/14/2030
16110-0833-10TAZORAC 0.05% GEL,TOP	$1154.96	Big4	Almirall, LLC	05/14/2030
16110-0833-10TAZORAC 0.05% GEL,TOP	$1154.96	FSS	Almirall, LLC	05/14/2030

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

Medicare Part D Spending

CMS annual spending data for Tazorac (2024)

Total Spending

$1.4M

Total Claims

1,572

Beneficiaries

770

Avg Cost/Unit

$15.76

Spending Trend

$1.3M(2020)→$2.1M(2021)→$2.1M(2022)→$1.7M(2023)→$1.4M(2024)

YoY Change:-2.9%

5yr CAGR:+2.5%

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

API Supply Chain4 active DMFs4 inactive

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

ALIVUS LIFE SCIENCES LTDTAZAROTENE

DMF 214222008

PCASTAZAROTENE

DMF 251612011

TARO PHARMACEUTICAL INDUSTRIES LTDTAZAROTENE, MICRONIZED

DMF 284702014

OLON SPATAZAROTENE

DMF 296002015

CARDINAL HEALTH PTS LLCInactiveTAZAROTENE 1.5 MG AND 4.5 MG CAPSULES

DMF 168642003

BASF SEInactiveTAZAROTENE

DMF 190892006

WATSON PHARMA PRIVATE LTDInactiveTAZAROTENE

DMF 200632006

PIRAMAL HEALTHCARE CANADA LTDInactiveTAZAROTENE

DMF 248742011

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Apr 17, 2018	SUPPL -10	View Letter (PDF)
Jul 25, 2017	SUPPL -9	View Letter (PDF)
Mar 2, 2011	SUPPL -8	View Letter (PDF)
Dec 8, 2003	SUPPL -5	View Letter (PDF)
Dec 8, 2003	SUPPL -3	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.05%

RLDAB

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: Jun 13, 1997

No patent or exclusivity listings for this strength.

#002 — 0.1%

RLDAB

0 patents0 exclusivities▾

GEL;TOPICAL | Approved: Jun 13, 1997