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TRIVAGIZOLE 3

NDA

CLOTRIMAZOLE | N021143 | SUN PHARMA CANADA 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

31 trials from ClinicalTrials.gov, 22 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Comparative Efficacy Study of 10 mg Dequalinium Chloride (Fluomizin) in the Treatment of Vulvovaginal Candidiasis NCT02242695	Phase 4	Completed	Medinova AG	150	2014-11 → 2016-04
Phase I/II Randomized Study of Hydroxyurea With or Without Clotrimazole in Patients With Sickle Cell Anemia NCT00004492	Phase 1/2	Completed	University of North Carolina	20	1999-10 → 2001-09
Clinical Study to Assess the Efficacy and Safety of G238 Compared to Clotrimazole Otic Solution in the Treatment of Otomycosis NCT01993823	Phase 3	Completed	Salvat	190	2013-05 → 2014-11
Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.NCT03005353	Phase 2/3	Completed	Assiut University	100	2018-03-01 → 2020-01-31
A Comparison of the Safety and Effectiveness of Fluconazole or Clotrimazole in the Treatment of Fungal Infections of the Mouth and Throat in Patients With AIDS NCT00002282	N/A	Completed	Pfizer	—	—
Study of Clotrimazole and Hydroxyurea in Patients With Sickle Cell Syndromes NCT00004404	N/A	Completed	Boston Children's Hospital	20	1997-04 → 2002-09
Effectiveness Study of Ketoconazole and Betamethasone to Treat Fungal Infection and Dermatophytosis NCT02582177	Phase 3	Completed	Ache Laboratorios Farmaceuticos S.A.	125	2019-06-11 → 2020-03-24
Effectiveness of 3% Boric Acid in 70% Alcohol Versus 1% Clotrimazole Solution in Otomycosis Patients NCT01547221	N/A	Completed	Khon Kaen Hospital	120	2012-03 → 2015-04
Comparison of Two Topical Formulations Containing Clindamycin and Clotrimazole in Patients With Vaginal Infections NCT01697826	Phase 4	Completed	Dr Bharti Daswani	73	2011-04 → 2011-09
Efficacy of Slow Release Clotrimazole Varnish Treating Denture Stomatitis Comparing to Traditional Treatment of Troches NCT00835029	Phase 2	Completed	Hadassah Medical Organization	13	2009-03 → 2012-02

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs

Highest NADAC/Unit

$0.3026

per gm

Lowest NADAC/Unit

$0.3026

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
516722062003-DAY VAGINAL CREAM	$0.3026	GM	Generic	—	2026-06-17
24385011009CLOTRIMAZOLE-3 2% CREAM	$0.3026	GM	Generic	—	2026-06-17
70677123101FT CLOTRIMAZOLE-3 2% CREAM	$0.3026	GM	Generic	—	2026-06-17
49348037954SM 3-DAY VAGINAL CREAM	$0.3026	GM	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain5 active DMFs7 inactive

5 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

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

CORDEN PHARMA BERGAMO SPAInactiveCLOTRIMAZOLE

DMF 107131994

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

2 letters from Drugs@FDA

Date	Submission	Document
Aug 25, 2016	SUPPL -12	View Letter (PDF)
Apr 12, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2%

0 patents0 exclusivities▴

CREAM;VAGINAL | Approved: Apr 12, 2000

No patent or exclusivity listings for this strength.