Viewing data from:

LUZU

NDA

LULICONAZOLE | N204153 | BAUSCH HEALTH US LLC

1 strength4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Active (4)Today

2027

2028

2029

2030

2031

2032

2033

2034

Today

Apr. 28, 2034

Sep. 6, 2033

Sep. 6, 2033

Sep. 6, 2033

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 Luzu (2023)

Total Spending

$18K

Total Claims

Beneficiaries

Avg Cost/Unit

$8.14

Spending Trend

$131K(2019)→$47K(2020)→$41K(2021)→$27K(2022)→$18K(2023)

YoY Change:-0.5%

5yr CAGR:+0.1%

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

API Supply Chain5 active DMFs2 inactive

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

HAMARI PFST LTDLULICONAZOLE

DMF 231962009

ALIVUS LIFE SCIENCES LTDLULICONAZOLE

DMF 299192015

TARO PHARMACEUTICAL INDUSTRIES LTDLULICONAZOLE

DMF 312172017

MAITHRI DRUGS PRIVATE LTDLULICONAZOLE

DMF 329352018

VIWIT PHARMACEUTICAL CO LTDLULICONAZOLE (DRUG SUBSTANCE)

DMF 363662021

KATAYAMA SEIYAKUSYO CO LTDInactiveLULICONAZOLE

DMF 281802014

VIWIT PHARMACEUTICAL CO LTDInactiveLULICONAZOLE

DMF 284092014

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Feb 26, 2018	SUPPL -4	View Letter (PDF)
Feb 26, 2018	SUPPL -5	View Letter (PDF)
Feb 9, 2017	SUPPL -2	View Letter (PDF)
Nov 15, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

RLD

4 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Nov 14, 2013

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8980931	Apr 28, 2034	—	—	Yes	—	—
9012484	Sep 6, 2033	—	Yes	Yes		—
9199977	Sep 6, 2033	—	Yes	Yes	—	—
9453006	Sep 6, 2033	—	Yes	—	—	—