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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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Tazorac (2023)

Total Spending

$1.7M

Total Claims

1,983

Beneficiaries

908

Avg Cost/Unit

$16.23

Spending Trend

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

YoY Change:+4.8%

5yr CAGR:+4.4%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain3 active DMFs4 inactive

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

ALIVUS LIFE SCIENCES LTDTAZAROTENE

DMF 214222008

PCASTAZAROTENE

DMF 251612011

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