Viewing data from:

INZIRQO

NDA

HYDROCHLOROTHIAZIDE | N219141 | NOVITIUM PHARMA LLC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2026

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Today

11878022

Jan. 23, 2044

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

301 trials from ClinicalTrials.gov — 1 recruiting, 250 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Determinants of Warfarin Metabolism NCT00162474	N/A	Recruiting	Hadassah Medical Organization	1,000	2003-09 → 2030-12
Valsartan/Hydrochlorothiazide Combination vs Amlodipine in Patients With Hypertension, Diabetes, and Albuminuria.NCT00171561	Phase 4	Completed	Novartis	144	2003-03 → 2006-09
Effect of Licorice and Hydrochlorothiazide on Plasma Potassium NCT00605202	Phase 4	Completed	University of Oulu	10	2008-02 → 2009-01
Salt Loading and Thiazide Intervention Study NCT00896389	Phase 4	Completed	University of Maryland, Baltimore	124	2009-10 → 2013-03
Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Non-Fasting Conditions NCT01149473	Phase 1	Completed	Teva Pharmaceuticals USA	80	2004-03 → 2004-04
ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling NCT01176032	Phase 4	Completed	Novartis Pharmaceuticals	74	2010-06 → 2013-04
Clinical Assessment Of Association Pharmacokinetics Atorvastatin + Losartana + Hydrochlorothiazide NCT01692717	Phase 1	Completed	Azidus Brasil	90	2013-02-28 → 2013-05-31
Randomized, Open Labeled Clinical Trial to Compare the Effectiveness of Amlodipine/Valsartan vs Hydrochlorothiazide/Telmisartan on Glucose Tolerance in Patients With Hypertension With Metabolic Syndrome NCT01819220	Phase 4	Completed	Yonsei University	16	2009-04 → 2014-11
Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide (Double Doses)NCT01767298	N/A	Completed	Damanhour University	24	2012-10 → 2012-12
Telmisartan With or Without Hydrochlorothiazide in Patients With Mild-to-moderate Hypertension NCT02177435	Phase 3	Completed	Boehringer Ingelheim	491	1999-02

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$4.46

per ml

Lowest NADAC/Unit

$4.46

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
70954052210INZIRQO 10 MG/ML ORAL SUSP	$4.46	ML	Brand	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$271.81

Highest Price

$358.04

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
70954-0522-10HYDROCHLOROTHIAZIDE 10MG/ML SUSP,ORAL	$358.04	FSS	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
70954-0522-10HYDROCHLOROTHIAZIDE 10MG/ML SUSP,ORAL	$271.81	Big4	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain18 active DMFs10 inactive

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

CAMBREX PROFARMACO MILANO SRLHYDROCHLOROTHIAZIDE

DMF 8811965

TAPI NL BVHYDROCHLOROTHIAZIDE

DMF 21151973

TAPI NL BVHYDROCHLOROTHIAZIDE

DMF 40281980

UNICHEM LABORATORIES LTDHYDROCHLOROTHIAZIDE USP

DMF 162782002

IPCA LABORATORIES LTDHYDROCHLOROTHIAZIDE USP

DMF 167072003

CHANGZHOU PHARMACEUTICAL FACTORYHYDROCHLOROTHIAZIDE

DMF 167502003

ZAKLADY FARMACEUTYCZNE POLPHARMA SAHYDROCHLOROTHIAZIDE

DMF 175992004

APITORIA PHARMA PRIVATE LTDHYDROCHLOROTHIAZIDE USP

DMF 177282004

IPCA LABORATORIES LTDHYDROCHLOROTHIAZIDE USP, PROCESS II

DMF 185632005

VALENS MOLECULES PRIVATE LTDHYDROCHLOROTHIAZIDE USP

DMF 197212006

UNICHEM LABORATORIES LTDHYDROCHLOROTHIAZIDE USP - PROCESS #2

DMF 205342007

CTX LIFE SCIENCES PVT LTDHYDROCHLOROTHIAZIDE USP

DMF 210392007

ZYDUS LIFESCIENCES LTDHYDROCHLOROTHIAZIDE USP

DMF 220272008

ALEMBIC PHARMACEUTICALS LTDHYDROCHLOROTHIAZIDE USP

DMF 222532008

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDHYDROCHLOROTHIAZIDE USP

DMF 225412008

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)HYDROCHLOROTHIAZIDE USP

DMF 258492012

MACLEODS PHARMACEUTICALS LTDHYDROCHLOROTHIAZIDE USP

DMF 339232019

LAURUS LABS LTDHYDROCHLOROTHIAZIDE USP

DMF 418892025

MICRO CHEMS LTDInactiveHYDROCHLOROTHIAZIDE USP

DMF 10591967

SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORPInactiveHYDROCHLOROTHIAZIDE IN PHIL PA

DMF 44361982

LABORATORIOS JULIAN DE MEXICO SAInactiveHYDROCHLOROTHIAZIDE

DMF 44881982

ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVInactiveHYDROCHLOROTHIAZIDE

DMF 45081982

CHANGZHOU PHARMACEUTICAL FACTORYInactiveHYDROCHLOROTHIAZIDE

DMF 49241983

CHINOIN PHARMACEUTCIAL AND CHEMICAL WORKS CO LTDInactiveHYDROCHLOROTHIAZIDE

DMF 51251983

SMITHKLINE AND BECKMAN INCInactiveHYDROCHLOROTHIAZIDE

DMF 56141984

ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVInactiveHYDROCHLOROTHIAZIDE

DMF 60551985

UNICHEM LABORATORIES LTDInactiveHYDROCHLOROTHIAZIDE B.P.

DMF 62371985

SUZHOU LIXIN PHARMACEUTICAL CO LTDInactiveHYDROCHLOROTHIAZIDE

DMF 211812007

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 7, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/ML

RLD

1 patent0 exclusivities▴

FOR SUSPENSION;ORAL | Approved: Jan 28, 2025

Patents (1) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11878022	Jan 23, 2044	—	—	Yes		—