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BENICAR HCT

NDA

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | N021532 | COSETTE PHARMACEUTICALS INC

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Apotex Inc v. Daiichi Sankyo, Inc. et al 1:2015cv03695 2 patentsANDA 204261olmesartan medoxomil/hydrochlorothiazide	N.D. Ill.	2015-04-27	Terminated 2016-01-08	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Public Citizen FDA-2017-P-6513 · 14 docket documents Public Citizen, a consumer advocacy organization, filed this petition on November 15, 2017 under Section 355(e) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA immediately remove from the market all medications containing olmesartan medoxomil (marketed as Benicar, Benicar HCT, Az	Other	2017-11-16	Denied	Public Citizen

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

Clinical Trials

24 trials from ClinicalTrials.gov, 23 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Elderly Patients With Hypertension NCT00412932	Phase 4	Completed	Daiichi Sankyo	178	2006-12 → 2008-04
Long-Term Safety of Azilsartan Medoxomil and Chlorthalidone Compared to Olmesartan Medoxomil and Hydrochlorothiazide in Participants With Hypertension and Kidney Disease NCT01309828	Phase 3	Completed	Takeda	153	2011-03 → 2012-10
Use of the Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension NCT00430508	Phase 3	Completed	Daiichi Sankyo	972	2007-02 → 2008-05
An Examination of the Safety and Blood Pressure Lowering Effect of Increasing Doses of Benicar® and Benicar® HCT in Patients With Hypertension NCT00185068	Phase 4	Completed	Daiichi Sankyo	110	2004-03 → 2004-10
Efficacy and Safety of Azilsartan Medoxomil Plus Chlorthalidone in Participants With Moderate to Severe Hypertension NCT00846365	Phase 3	Completed	Takeda	1,085	2009-03 → 2010-06
An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Patients With Type II Diabetes NCT00403481	Phase 4	Completed	Daiichi Sankyo	192	2006-11 → 2007-12
Fasting Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg and Benicar HCT® Tablets 40 mg/25 mg NCT01020214	Phase 1	Completed	Mylan Pharmaceuticals Inc	36	2006-11 → 2006-11
Bioequivalence Study of Torrent's Olmesartan Medoxomil, Amlodipine and Hydrochloride Tablets Under Fasting Conditions.NCT02962336	Phase 1	Completed	Torrent Pharmaceuticals Limited	34	2011-05 → 2011-06
Lowering Blood Pressure in Primary Care in Vienna NCT02377661	Phase 4	Completed	Wilhelminenspital Vienna	229	2015-03 → 2017-05-30
Olmesartan in Essential Hypertension NCT00185172	Phase 3	Completed	Sankyo Pharma Gmbh	2,333	2002-01 → 2005-06

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$17.20

per ea

Lowest NADAC/Unit

$11.32

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00713086430BENICAR HCT 40-12.5 MG TABLET	$17.20	EA	Brand	$0.2379	2026-07-01
00713086530BENICAR HCT 40-25 MG TABLET	$15.65	EA	Brand	$0.2317	2026-06-17
00713086330BENICAR HCT 20-12.5 MG TABLET	$11.32	EA	Brand	$0.1817	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 | 6 NDCs (6 FSS)

Lowest Price

$32.75

Highest Price

$508.37

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00713-0865-30BENICAR HCT 40MG/25MG TAB	$262.57	FSS	Cosette Pharmaceutical, Inc.	08/14/2027
42291-0925-90HYDROCHLOROTHIAZIDE 12.5MG/OLMESARTAN 40MG TA	$472.14	FSS	AvKare, LLC	06/14/2028
42291-0924-90HYDROCHLOROTHIAZIDE 12.5MG/OLMESARTAN 20MG TA	$368.36	FSS	AvKare, LLC	06/14/2028
42291-0926-90HYDROCHLOROTHIAZIDE 25MG/OLMESARTAN 40MG TA	$508.37	FSS	AvKare, LLC	06/14/2028
00713-0863-30BENICAR HCT 20MG/12.5MG TAB	$32.75	FSS	Cosette Pharmaceutical, Inc.	08/14/2027
00713-0864-30BENICAR HCT 40MG/12.5MG TAB	$92.78	FSS	Cosette Pharmaceutical, Inc.	08/14/2027

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

Medicare Part D Spending

CMS annual spending data for Benicar HCT (2024)

Total Spending

$6.1M

Total Claims

8,866

Beneficiaries

1,781

Avg Cost/Unit

$12.09

Spending Trend

$11.0M(2019)→$11.5M(2020)→$9.7M(2021)→$8.0M(2022)→$7.3M(2023)→$6.1M(2024)

YoY Change:+2.6%

5yr CAGR:+5.7%

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

Approval Letters

16 letters from Drugs@FDA

Date	Submission	Document
Apr 16, 2025	SUPPL -38	View Letter (PDF)
Aug 21, 2020	SUPPL -37	View Letter (PDF)
Feb 12, 2016	SUPPL -15	View Letter (PDF)
Sep 24, 2014	SUPPL -26	View Letter (PDF)
Jun 30, 2014	SUPPL -25	View Letter (PDF)
Jun 17, 2014	SUPPL -24	View Letter (PDF)
Jul 5, 2013	SUPPL -22	View Letter (PDF)
Dec 11, 2012	SUPPL -21	View Letter (PDF)
Sep 24, 2012	SUPPL -20	View Letter (PDF)
Jan 20, 2012	SUPPL -16	View Letter (PDF)
May 5, 2011	SUPPL -13	View Letter (PDF)
May 5, 2011	SUPPL -14	View Letter (PDF)
Nov 19, 2007	SUPPL -8	View Letter (PDF)
Jul 15, 2005	SUPPL -4	View Letter (PDF)
Nov 16, 2004	SUPPL -1	View Letter (PDF)
Jun 8, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#002 — 12.5MG;20MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 5, 2003

No patent or exclusivity listings for this strength.

#003 — 12.5MG;40MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 5, 2003

#005 — 25MG;40MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 5, 2003