Viewing data from:

FUROSEMIDE

NDA

FUROSEMIDE | N018823 | HIKMA PHARMACEUTICALS USA INC

2 strengths0 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

169 trials from ClinicalTrials.gov — 8 recruiting, 4 active, 103 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
Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib NCT06899061	Phase 1	Active	AstraZeneca	41	2025-03-25 → 2028-05-19
Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma NCT05470283	Phase 1	Active	M.D. Anderson Cancer Center	21	2022-09-07 → 2027-04-01
ACetazolamide in Patients With Heart Failure, to Decrease Weight and relIEVE Symptoms.NCT07737964	Phase 3	Not Yet Recruiting	University Hospital, Montpellier	366	2026-10 → 2029-01
The Impact of Intraoperative Diuretic Use on Delayed Graft Function Following Deceased Donor Renal Transplantation NCT07726134	N/A	Not Yet Recruiting	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's	160	2026-08 → 2028-12
Outpatient Hypertonic Saline and Loop Diuretic Combination Therapy in Cardiorenal NCT07596329	Phase 3	Not Yet Recruiting	University of Monastir	60	2026-09-01 → 2027-12-30
DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure NCT05276219	Phase 4	Recruiting	Rigshospitalet, Denmark	1,041	2023-09-14 → 2027-06-30
Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury NCT06229990	Phase 4	Recruiting	Chiang Mai University	80	2024-01-01 → 2028-12-31
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

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 6 NDCs

Highest NADAC/Unit

$0.0293

per ea

Lowest NADAC/Unit

$0.0268

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00054429925FUROSEMIDE 40 MG TABLET	$0.0293	EA	Generic	—	2026-08-19
00054429931FUROSEMIDE 40 MG TABLET	$0.0293	EA	Generic	—	2026-08-19
00054829925FUROSEMIDE 40 MG TABLET	$0.0293	EA	Generic	—	2026-08-19
00054429725FUROSEMIDE 20 MG TABLET	$0.0268	EA	Generic	—	2026-08-19
00054429731FUROSEMIDE 20 MG TABLET	$0.0268	EA	Generic	—	2026-08-19
00054829725FUROSEMIDE 20 MG TABLET	$0.0268	EA	Generic	—	2026-08-19

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

API Supply Chain8 active DMFs14 inactive

8 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

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

1 letter from Drugs@FDA

Date	Submission	Document
Jul 17, 2017	SUPPL -44	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 20MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 10, 1983

No patent or exclusivity listings for this strength.

#002 — 40MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 10, 1983