Viewing data from:

COZAAR

NDA

LOSARTAN POTASSIUM | N020386 | 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

285 trials from ClinicalTrials.gov — 5 recruiting, 2 active, 197 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Hearing Outcomes Using Fractionated Proton Radiation Therapy for Vestibular Schwannoma NCT01199978	Phase 2	Active	Massachusetts General Hospital	30	2011-03-08 → 2026-11
Losartan and Nivolumab in Combination With FOLFIRINOX and SBRT in Localized Pancreatic Cancer NCT03563248	Phase 2	Active	Massachusetts General Hospital	168	2018-08-10 → 2027-04
Role of Sympathetic Overactivity and Angiotensin II in PTSD and CV NCT02560805	Phase 2	Recruiting	Emory University	134	2015-10 → 2027-03-30
Determinants of Warfarin Metabolism NCT00162474	N/A	Recruiting	Hadassah Medical Organization	1,000	2003-09 → 2030-12
NT-proBNP Selected Prevention of Cardiac Events in Diabetic Patients NCT02817360	Phase 4	Recruiting	Martin Huelsmann	2,400	2016-02 → 2026-12
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia NCT02735707	Phase 3	Recruiting	UMC Utrecht	20,000	2016-04-11 → 2028-02
Losartan + Sunitinib in Treatment of Osteosarcoma NCT03900793	Phase 1	Recruiting	University of Colorado, Denver	41	2019-08-26 → 2029-08-01
ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling NCT01176032	Phase 4	Completed	Novartis Pharmaceuticals	74	2010-06 → 2013-04
A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan NCT01197001	Phase 1	Completed	Hanmi Pharmaceutical Company Limited	72	2010-08 → 2010-11
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

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 5 NDCs

Highest NADAC/Unit

$6.15

per ea

Lowest NADAC/Unit

$3.36

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
78206012301COZAAR 100 MG TABLET	$6.15	EA	Brand	$0.0435	2026-06-17
78206012302COZAAR 100 MG TABLET	$6.15	EA	Brand	$0.0435	2026-06-17
78206012201COZAAR 50 MG TABLET	$4.49	EA	Brand	$0.0337	2026-06-17
78206012202COZAAR 50 MG TABLET	$4.49	EA	Brand	$0.0337	2026-06-17
78206012101COZAAR 25 MG TABLET	$3.36	EA	Brand	$0.0215	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 | 10 NDCs (5 FSS, 5 Big4)

Lowest Price

$96.71

Highest Price

$542.05

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
78206-0121-01COZAAR 25MG TAB	$296.74	FSS	Organon LLC	01/14/2027
78206-0121-01COZAAR 25MG TAB	$216.51	Big4	Organon LLC	01/14/2027
78206-0122-01COZAAR 50MG TAB	$132.46	FSS	Organon LLC	01/14/2027
78206-0122-01COZAAR 50MG TAB	$96.71	Big4	Organon LLC	01/14/2027
78206-0122-02COZAAR 50MG TAB	$396.91	FSS	Organon LLC	01/14/2027
78206-0122-02COZAAR 50MG TAB	$289.95	Big4	Organon LLC	01/14/2027

Showing 6 of 10 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Cozaar (2024)

Total Spending

$4.4M

Total Claims

12,050

Beneficiaries

2,903

Avg Cost/Unit

$4.53

Spending Trend

$1.5M(2021)→$4.9M(2022)→$4.8M(2023)→$4.4M(2024)

YoY Change:-3.8%

5yr CAGR:+3.2%

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

API Supply Chain30 active DMFs18 inactive

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

TAPI NL BVLOSARTAN POTASSIUM

DMF 169962003

LUPIN LTDLOSARTAN POTASSIUM USP (AMORPHOUS)

DMF 192952006

APITORIA PHARMA PRIVATE LTDLOSARTAN POTASSIUM USP DRUG SUBSTANCE

DMF 196712006

HETERO LABS LTDLOSARTAN POTASSIUM (FORM 1)

DMF 199882006

DR REDDYS LABORATORIES LTDLOSARTAN POTASSIUM FORM-1

DMF 203582007

JUBILANT BIOSYS LTDLOSARTAN POTASSIUM USP

DMF 211772007

CALYX CHEMICALS AND PHARMACEUTICALS LTDLOSARTAN POTASSIUM USP

DMF 219112008

ORCHID PHARMA LTDLOSARTAN POTASSIUM (NON-STERILE BULK API)

DMF 219142008

ALEMBIC PHARMACEUTICALS LTDLOSARTAN POTASSIUM USP

DMF 221162008

ZYDUS LIFESCIENCES LTDLOSARTAN POTASSIUM USP

DMF 223642008

UNICHEM LABORATORIES LTDLOSARTAN POTASSIUM USP

DMF 225562009

GRANULES INDIA LTDLOSARTAN POTASSIUM USP

DMF 227112009

SUVEN LIFE SCIENCES LTDLOSARTAN POTASSIUM USP

DMF 246542011

MICRO LABS LTDLOSARTAN POTASSIUM USP

DMF 246882010

TAPI NL BVLOSARTAN POTASSIUM

DMF 256542012

LUPIN LTDLOSARTAN POTASSIUM USP (CRYSTALLINE)

DMF 258792012

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDLOSARTAN POTASSIUM USP

DMF 271982013

ZHEJIANG TIANYU PHARMACEUTICAL CO LTDLOSARTAN POTASSIUM

DMF 283462014

VASUDHA PHARMA CHEM LTDLOSARTAN POTASSIUM USP

DMF 325302018

MACLEODS PHARMACEUTICALS LTDLOSARTAN POTASSIUM

DMF 331672018

AURORE LIFE SCIENCES PRIVATE LTDLOSARTAN POTASSIUM USP

DMF 350762020

MSN LIFE SCIENCES PRIVATE LTDLOSARTAN POTASSIUM USP

DMF 356852021

ZHEJIANG TIANYU PHARMACEUTICAL CO LTDLOSARTAN POTASSIUM (L-3)

DMF 362262021

DR REDDYS LABORATORIES LTDLOSARTAN POTASSIUM (FORM-1)

DMF 363872021

IOL CHEMICALS AND PHARMACEUTICALS LTDLOSARTAN POTASSIUM USP

DMF 371062022

ATUL BIOSCIENCE LTDLOSARTAN POTASSIUM USP

DMF 378932022

VIYASH LIFE SCIENCES PRIVATE LTDLOSARTAN POTASSIUM USP

DMF 385312024

SYNERGENE ACTIVE INGREDIENTS PVT LTDLOSARTAN POTASSIUM USP

DMF 389542023

DIVIS LABORATORIES LTDLOSARTAN POTASSIUM USP

DMF 405522024

IPCA LABORATORIES LTDLOSARTAN POTASSIUM USP (LB4 PROCESS)

DMF 407602024

MAPRIMED SAInactiveLOSARTAN POTASSIUM

DMF 163112002

IPCA LABORATORIES LTDInactiveLOSARTAN POTASSIUM

DMF 165262003

IPCA LABORATORIES LTDInactiveLOSARTAN POTASSIUM USP (PROCESS II)

DMF 174602004

MEDICHEM SAInactiveLOSARTAN POTASSIUM

DMF 178332004

LEK PHARMACEUTICALS DDInactiveLOSARTAN POTASSIUM

DMF 178672004

CADILA HEALTHCARE LTDInactiveLOSARTAN POTASSIUM USP

DMF 181532005

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveLOSARTAN POTASSIUM USP

DMF 186922005

ZHEJIANG TIANYU PHARMACEUTICAL CO LTDInactiveLOSARTAN POTASSIUM

DMF 187802005

CADILA PHARMACEUTICALS LTDInactiveLOSARTAN POTASSIUM USP

DMF 205092007

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDInactiveLOSARTAN POTASSIUM, USP

DMF 207162007

CIPLA LTDInactiveLOSARTAN POTASSIUM USP

DMF 209672007

MYLAN LABORATORIES LTDInactiveLOSARTAN POTASSIUM USP

DMF 210462007

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDInactiveLOSARTAN POTASSIUM USP

DMF 220732008

WANBURY LTDInactiveLOSARTAN POTASSIUM

DMF 221502008

IPCA LABORATORIES LTDInactiveLosartan Potassium USP (LB5 Process)

DMF 222192009

FLAMMA SPAInactiveLOSARTAN POTASSIUM

DMF 233022009

POLYDRUG LABORATORIES PVT LTDInactiveLOSARTAN POTASSIUM

DMF 249152011

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDInactiveLOSARTAN POTASSIUM

DMF 257372011

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

Approval Letters

22 letters from Drugs@FDA

Date	Submission	Document
Jun 25, 2025	SUPPL -69	View Letter (PDF)
Oct 21, 2021	SUPPL -64	View Letter (PDF)
Oct 17, 2018	SUPPL -62	View Letter (PDF)
Dec 15, 2015	SUPPL -54	View Letter (PDF)
Oct 1, 2014	SUPPL -61	View Letter (PDF)
Jan 21, 2014	SUPPL -60	View Letter (PDF)
Mar 29, 2013	SUPPL -58	View Letter (PDF)
Oct 3, 2012	SUPPL -57	View Letter (PDF)
Nov 21, 2011	SUPPL -56	View Letter (PDF)
Jun 17, 2011	SUPPL -53	View Letter (PDF)
Sep 27, 2010	SUPPL -52	View Letter (PDF)
Jun 16, 2009	SUPPL -49	View Letter (PDF)
Sep 25, 2006	SUPPL -46	View Letter (PDF)
Sep 25, 2006	SUPPL -43	View Letter (PDF)
Sep 18, 2006	SUPPL -45	View Letter (PDF)
Apr 7, 2006	SUPPL -42	View Letter (PDF)
Apr 13, 2005	SUPPL -40	View Letter (PDF)
Apr 13, 2005	SUPPL -39	View Letter (PDF)
Mar 16, 2004	SUPPL -19	View Letter (PDF)
Mar 16, 2004	SUPPL -29	View Letter (PDF)
Mar 28, 2003	SUPPL -32	View Letter (PDF)
Sep 17, 2002	SUPPL -28	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 25MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 14, 1995

No patent or exclusivity listings for this strength.

#002 — 50MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 14, 1995

#003 — 100MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 13, 1998