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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Hyzaar (2023)

Total Spending

$1.7M

Total Claims

4,632

Beneficiaries

995

Avg Cost/Unit

$5.79

Spending Trend

$494K(2021)→$1.9M(2022)→$1.7M(2023)

YoY Change:+9.5%

5yr CAGR:+7.7%

Source: CMS Medicare Part D Spending by Drug (2023). 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