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FUROSEMIDE

NDA

FUROSEMIDE | N018267 | HIKMA PHARMACEUTICALS USA 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

154 trials from ClinicalTrials.gov — 2 recruiting, 2 active, 96 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Kidney Sodium Content in Cardiorenal Patients NCT04170855	N/A	Active	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's	50	2020-10-20 → 2027-02-28
Salt-Sensitivity and Immunity Cell Activation NCT03753204	Phase 1/2	Active	Vanderbilt University Medical Center	20	2021-09-01 → 2026-09-15
Controlled Fluid Removal in Critical Ill Patients With Fluid Overload in the Intensive Care Unit.NCT04180397	Phase 4	Recruiting	Morten H. Bestle	1,000	2020-08-17 → 2028-04-15
Furosemide Stress Test Predicting Early Graft Function in Kidney Transplantation NCT03071536	N/A	Recruiting	King Chulalongkorn Memorial Hospital	180	2016-11-25 → 2027-05
Single Dose of Furosemide to Improve Respiratory Distress in Moderate to Severe Bronchiolitis NCT02469597	Phase 2	Completed	Northwell Health	46	2013-10 → 2016-04
Effects of Fluid Balance Control in Critically Ill Patients NCT02765009	N/A	Completed	Central Hospital, Nancy, France	1,411	2016-06-01 → 2020-05-25
Effect of Furosemide on Confirmation of Ureteral Patency During Routine Cystoscopy NCT02960412	Phase 4	Completed	University of South Florida	150	2017-05-01 → 2018-06-30
Nephropathy In Type 2 Diabetes and Cardio-renal Events NCT00535925	Phase 4	Completed	University of Campania Luigi Vanvitelli	850	2005-10 → 2019-05
Evaluation of Combined Action Between Natrecor and Furosemide on Kidney and Neurohormone Responses in Chronic Heart Failure: A Phase-IV study704.351 / DSS NCT00652652	Phase 4	Completed	Scios, Inc.	—	2003-03 → 2004-01
A Comparison of Hydrochlorothiazide and Metolazone in Combination With Furosemide in Congestive Heart Failure Patients NCT00690521	N/A	Completed	University of New Mexico	8	2004-10-26 → 2009-11-10

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

$0.4178

per ml

Lowest NADAC/Unit

$0.3189

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00143915525FUROSEMIDE 20 MG/2 ML VIAL	$0.4178	ML	Generic	—	2026-06-17
00143915801FUROSEMIDE 500 MG/50 ML VIAL	$0.4178	ML	Generic	—	2026-06-17
00143915710FUROSEMIDE 100 MG/10 ML VIAL	$0.3189	ML	Generic	—	2026-06-17
00143915901FUROSEMIDE 1,000 MG/100 ML VL	$0.3189	ML	Generic	—	2026-06-17

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

API Supply Chain9 active DMFs14 inactive

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

TAPI NL BVFUROSEMIDE USP

DMF 25651975

FIS FABBRICA ITALIANA SINTETICI SPAFUROSEMIDE

DMF 35131979

IPCA LABORATORIES LTDFUROSEMIDE USP

DMF 101091993

EUROAPI GERMANY GMBHFUROSEMIDE (BULK)

DMF 117851995

SRI KRISHNA PHARMACEUTICALS LTDFUROSEMIDE USP

DMF 233962009

CURIA INDIA PRIVATE LIMITEDFUROSEMIDE USP

DMF 302882016

KALINTIS HEALTHCARE PVT LTDFUROSEMIDE USP

DMF 330622018

SMS LIFESCIENCES INDIA LTDFUROSEMIDE USP

DMF 399602024

AMBITION PHARMAFUROSEMIDE IP/BP/EP/USP

DMF 437092026

HOECHST CELANESE CORPInactiveFUROSEMIDE

DMF 18341971

SOLMAG SPAInactiveFUROSEMIDE

DMF 26491976

PLANTEX LTD CHEMICAL AND PHARMACEUTICAL WORKSInactiveFUROSEMIDE USP

DMF 30331977

CIECH POLFAInactiveFUROSEMIDE

DMF 31341978

SCHARPER SPAInactiveFUROSEMIDE

DMF 32651978

CHINOIN PHARMACEUTCIAL AND CHEMICAL WORKS CO LTDInactiveFUROSEMIDE USP XIX, BULK

DMF 33311978

DINAMITE DIPHARMA SPAInactiveFUROSEMIDE USP

DMF 33641978

ORION CORP FARMOS CHEMICAL PLANTInactiveFUROSEMIDE

DMF 34351979

SELOC AGInactiveFUROSEMIDE

DMF 55471984

SALSBURY CHEMICALS INCInactiveFUROSEMIDE USP

DMF 59931985

INTERMEDI CHIMICI SINTETICI SPA ZONA INDUSTRIALEInactiveFUROSEMIDE USP

DMF 63231986

TRIFARMA SPAInactiveFUROSEMIDE

DMF 128961998

OLON SPAInactiveFUROSEMIDE

DMF 199752006

MANGALAM DRUGS AND ORGANICS LTDInactiveFUROSEMIDE USP

DMF 253182011

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Oct 3, 2024	SUPPL -29	View Letter (PDF)
May 11, 2023	SUPPL -27	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.