Viewing data from:

CLOTIC

NDA

CLOTRIMAZOLE | N217628 | CARWIN PHARMACEUTICAL ASSOCIATES LLC

1 strength1 unique patent3 unique exclusivities

Patent Timeline

1 unique patent, 3 exclusivities by expiration date

Active (1)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

2043

Today

12246006

May. 26, 2042

Sep. 26, 2028

ODE-549

Sep. 26, 2032

GAIN

Sep. 26, 2037

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

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.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 30, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

RLD

1 patent3 exclusivities▴

SOLUTION/DROPS;OTIC | Approved: Sep 26, 2025

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
12246006	May 26, 2042	—	—	Yes		—

Exclusivities (3)

Code	Date	Status
GAIN	Sep 26, 2037	Active
NP	Sep 26, 2028	Active
ODE-549	Sep 26, 2032	Active

Change History (2)

Recent changes detected for this application.

ADDED7/1/2026

New: New record

MODIFIEDExclusivity Expiration7/1/2026

Old: Sep 26, 2033

New: Sep 26, 2037