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ZAROXOLYN

NDA

METOLAZONE | N017386 | I3 PHARMACEUTICALS LLC

3 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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Zydus Pharmaceuticals (USA) Inc. FDA-2015-P-4946 · 4 docket documents Zydus Pharmaceuticals (USA) Inc. filed this citizen petition requesting that the FDA determine whether UCB Inc.'s ZAROXOLYN (metolazone) Tablets at 5 mg and 10 mg strengths, approved under NDA 017386, were voluntarily withdrawn for safety or effectiveness reasons. If the FDA determines the product w	505(q)	2015-12-23	Withdrawn	Zydus Pharmaceuticals (USA) Inc.
Citizen Petition from Lachman Consultant Services FDA-2015-P-3540 · 5 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client requesting that the FDA determine whether UCB Inc.'s ZAROXOLYN (metolazone) Tablets, 10 mg, approved under NDA 017386, were voluntarily withdrawn for safety or effectiveness reasons, and if not, to designate an appro	505(q)	2015-10-09	Withdrawn	Lachman Consultant Services

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

15 trials from ClinicalTrials.gov, 6 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
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
Comparison of Oral or Intravenous Thiazides vs Tolvaptan in Diuretic Resistant Decompensated Heart Failure NCT02606253	Phase 4	Completed	Vanderbilt University	60	2016-02 → 2018-10-31
Fasting Study of Metolazone Tablets 5 mg and Zaroloxyn® Tablets 5 mg NCT00649181	Phase 1	Completed	Mylan Pharmaceuticals Inc	52	2003-10 → 2003-11
AiDing Diuresis wIth Tolvaptan (ADD-IT)NCT02646540	Phase 1	Completed	Emory University	14	2016-01 → 2018-12-30
Fasting Study of Metolazone Tablets 10 mg and Zaroloxyn® Tablets 10 mg NCT00650195	Phase 1	Completed	Mylan Pharmaceuticals Inc	56	2004-02 → 2004-03
Fasting Study of Metolazone Tablets 2.5 mg and Zaroloxyn® Tablets 2.5 mg NCT00649051	Phase 1	Completed	Mylan Pharmaceuticals Inc	52	2002-12 → 2003-01
Coronavirus (COVID-19) ACEi/ARB Investigation NCT04330300	Phase 4	Suspended	National University of Ireland, Galway, Ireland	2,414	2020-04-30 → 2021-12-01
Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure (MELT-HF)--A Single Center Pilot Study.NCT02620384	Phase 3	Terminated	Aultman Health Foundation	147	2015-10-01 → 2017-12-29
Oral Metolazone and Intermittent Intravenous Furosemide Versus Continuous Infusion Furosemide in Acute Heart Failure NCT00904488	Phase 4	Terminated	University of North Carolina, Chapel Hill	11	2008-10 → 2017-11-14
Prospective Comparison of Metolazone Versus Chlorothiazide for Acute Decompensated Heart Failure With Diuretic Resistance NCT03574857	Phase 4	Terminated	University of Virginia	5	2018-06-01 → 2021-01-01

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

API Supply Chain5 active DMFs6 inactive

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

SIEGFRIED EVIONNAZ SAMETOLAZONE

DMF 57481985

CURIA NEW YORK INCMETOLAZONE, USP

DMF 119581996

CENTAUR PHARMACEUTICALS PRIVATE LTDMETOLAZONE USP

DMF 303102016

BIOPHORE INDIA PHARMACEUTICALS PVT LTDMETOLAZONE USP

DMF 328682018

MSN LIFE SCIENCES PRIVATE LTDMETOLAZONE USP

DMF 336982019

EASTMAN KODAK COInactiveMETOLAZONE (ZAROXOLYN)

DMF 46551982

SUMIKA FINE CHEMICALS CO LTDInactiveMETOLAZONE

DMF 64381986

HEXAGON LABORATORIES INCInactiveMETOLAZONE

DMF 64871986

DIOSYNTH BVInactiveMETOLAZONE

DMF 75291988

HOECHST MARION ROUSSEL SAInactiveMETOLAZONE

DMF 84211990

XIAN LIBANG PHARMACEUTICAL CO LTDInactiveMETOLAZONE USP

DMF 160012002

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jul 21, 2020	SUPPL -43	View Letter (PDF)
Aug 25, 2003	SUPPL -36	View Letter (PDF)
Oct 29, 2002	SUPPL -34	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#003 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982