Viewing data from:

HYZAAR

NDA

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | N020387 | ORGANON LLC A SUB OF ORGANON AND CO

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

41 trials from ClinicalTrials.gov — 1 recruiting, 30 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Determinants of Warfarin Metabolism NCT00162474	N/A	Recruiting	Hadassah Medical Organization	1,000	2003-09 → 2030-12
Tarka vs. Hyzaar in Patients With Metabolic Syndrome (STAR)NCT00234858	Phase 4	Completed	Abbott	280	2004-03
Bioequivalence Study of Losartan Potassium and Hydrochlorothiazide (100 mg / 25 mg Tablet) [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Hyzaar® (100 mg / 25 mg Tablet) [Reference Formulation, Merck & Co., Inc., USA] in Healthy Human Volunteers Under Fasting Conditions.NCT01218711	Phase 1	Completed	Torrent Pharmaceuticals Limited	—	—
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
Clinical Assessment Of Association Pharmacokinetics Atorvastatin + Losartana + Hydrochlorothiazide NCT01692717	Phase 1	Completed	Azidus Brasil	90	2013-02-28 → 2013-05-31
A 52 Week Study to Evaluate the Effects of Losartan With or Without HCTZ on Plasma Glucose, Metabolic Parameters, Blood Pressure in Hypertensive Patients With Metabolic Syndrome (0954A-331)NCT00546052	Phase 3	Completed	Organon and Co	1,738	2005-09-01 → 2008-01-01
Bioequivalency Study of Losartan Potassium/Hydrochlorothiazide 100 mg /25 mg Tablet Under Fed Conditions NCT01102465	N/A	Completed	Roxane Laboratories	25	2005-02 → 2005-03
Pharmacokinetic Drug Interactions Between Single and Concomitant Administrations of Amlodipine, Losartan, and Hydrochlorothiazide in Subjects With (Pre)Hypertension NCT01198249	Phase 1	Completed	Yonsei University	23	2010-09 → 2011-03
Pharmacokinetic Interactions of Losartan and Hydrochlorothiazide NCT01858623	N/A	Completed	Damanhour University	18	2013-02 → 2013-03
MK-0954E Study in Participants With Hypertension (MK-0954E-357)NCT01302691	Phase 3	Completed	Merck Sharp & Dohme LLC	327	2011-01-01 → 2012-04-01

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 6 NDCs

Highest NADAC/Unit

$6.82

per ea

Lowest NADAC/Unit

$5.01

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
78206014002HYZAAR 100-12.5 TABLET	$6.82	EA	Brand	$0.0755	2026-01-01
78206014001HYZAAR 100-12.5 TABLET	$6.82	EA	Brand	$0.0755	2026-01-01
78206014101HYZAAR 100-25 TABLET	$6.82	EA	Brand	$0.0798	2026-01-01
78206014102HYZAAR 100-25 TABLET	$6.82	EA	Brand	$0.0798	2026-01-01
78206013901HYZAAR 50-12.5 TABLET	$5.01	EA	Brand	$0.0621	2026-01-01
78206013902HYZAAR 50-12.5 TABLET	$5.01	EA	Brand	$0.0621	2026-01-01

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

VA Federal Supply Schedule

Government-negotiated contract prices | 12 NDCs (6 FSS, 6 Big4)

Lowest Price

$107.53

Highest Price

$599.91

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
78206-0140-02HYZAAR 100-12.5MG TAB	$599.91	FSS	Organon LLC	01/14/2027
78206-0140-02HYZAAR 100-12.5MG TAB	$441.91	Big4	Organon LLC	01/14/2027
78206-0139-01HYZAAR 50-12.5MG TAB	$146.41	FSS	Organon LLC	01/14/2027
78206-0139-01HYZAAR 50-12.5MG TAB	$107.53	Big4	Organon LLC	01/14/2027
78206-0139-02HYZAAR 50-12.5MG TAB	$439.22	FSS	Organon LLC	01/14/2027
78206-0139-02HYZAAR 50-12.5MG TAB	$321.06	Big4	Organon LLC	01/14/2027

Showing 6 of 12 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Hyzaar (2024)

Total Spending

$1.4M

Total Claims

3,947

Beneficiaries

883

Avg Cost/Unit

$5.50

Spending Trend

$494K(2021)→$1.9M(2022)→$1.7M(2023)→$1.4M(2024)

YoY Change:-5.0%

5yr CAGR:+3.3%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

27 letters from Drugs@FDA

Date	Submission	Document
Jun 25, 2025	SUPPL -76	View Letter (PDF)
Mar 28, 2023	SUPPL -71	View Letter (PDF)
Aug 24, 2020	SUPPL -67	View Letter (PDF)
Nov 12, 2019	SUPPL -64	View Letter (PDF)
Oct 17, 2018	SUPPL -63	View Letter (PDF)
Dec 15, 2015	SUPPL -47	View Letter (PDF)
Oct 1, 2014	SUPPL -60	View Letter (PDF)
Jan 21, 2014	SUPPL -59	View Letter (PDF)
Mar 29, 2013	SUPPL -57	View Letter (PDF)
Oct 3, 2012	SUPPL -56	View Letter (PDF)
Nov 21, 2011	SUPPL -54	View Letter (PDF)
Aug 31, 2011	SUPPL -55	View Letter (PDF)
Aug 18, 2011	SUPPL -52	View Letter (PDF)
Jun 17, 2011	SUPPL -50	View Letter (PDF)
Sep 27, 2010	SUPPL -48	View Letter (PDF)
Jun 17, 2009	SUPPL -45	View Letter (PDF)
Jan 8, 2007	SUPPL -40	View Letter (PDF)
Sep 18, 2006	SUPPL -41	View Letter (PDF)
Apr 25, 2006	SUPPL -38	View Letter (PDF)
Oct 25, 2005	SUPPL -37	View Letter (PDF)
Apr 13, 2005	SUPPL -35	View Letter (PDF)
Apr 13, 2005	SUPPL -34	View Letter (PDF)
Apr 12, 2005	SUPPL -33	View Letter (PDF)
Sep 30, 2003	SUPPL -15	View Letter (PDF)
Sep 30, 2003	SUPPL -27	View Letter (PDF)
Sep 30, 2003	SUPPL -13	View Letter (PDF)
Nov 7, 2002	SUPPL -24	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 12.5MG;50MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 28, 1995

No patent or exclusivity listings for this strength.

#002 — 25MG;100MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 10, 1998

#003 — 12.5MG;100MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 20, 2005