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LOTRIMIN

NDA

CLOTRIMAZOLE | N017613 | SCHERING PLOUGH HEALTHCARE PRODUCTS INC

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

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 Clotrimazole* (2023)

Total Spending

$24.5M

Total Claims

965,994

Beneficiaries

538,888

Avg Cost/Unit

$0.64

Spending Trend

$29.2M(2019)→$25.3M(2020)→$24.4M(2021)→$26.1M(2022)→$24.5M(2023)

YoY Change:-9.6%

5yr CAGR:-3.6%

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

API Supply Chain6 active DMFs6 inactive

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

ERREGIERRE SPACLOTRIMAZOLE USP-EP

DMF 63241986

FIS FABBRICA ITALIANA SINTETICI SPACLOTRIMAZOLE

DMF 75481988

OLON SPACLOTRIMAZOLE

DMF 98061992

CORDEN PHARMA BERGAMO SPACLOTRIMAZOLE

DMF 107131994

AMOLI ORGANICS PVT LTDCLOTRIMAZOLE USP

DMF 264832012

SNJ LABS PVT LTDCLOTRIMAZOLE USP

DMF 359022021

SIFAVITOR SPAInactiveCLOTRIMAZOLE USP XX

DMF 54891984

MILES PHARMACEUTICAL DIV MILES INCInactiveCLOTRIMAZOLE 250 MG ORAL TABLETS

DMF 55571984

CUTTER BIOLOGICAL DIV MILES LABORATORIES INCInactiveCLOTRIMAZOLE

DMF 67291986

BAYER AGInactiveCLOTRIMAZOLE

DMF 67711987

SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTDInactiveCLOTRIMAZOLE

DMF 197162006

JIANGSU YUNYANG GROUP PHARMACEUTICAL CO LTDInactiveCLOTRIMAZOLE

DMF 203972007

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

Products (1)

#001 — 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;TOPICAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.