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MICARDIS HCT

NDA

HYDROCHLOROTHIAZIDE; TELMISARTAN | N021162 | BOEHRINGER INGELHEIM

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

14 trials from ClinicalTrials.gov, 14 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
PROBE Parallel 6-week Treatment Comparing Telmisartan/Hydrochlorothiazide (HCT) (40/12.5 or 80/12.5) With Losartan/HCT (50/12.5) Using Ambulatory Blood Pressure Monitoring (ABPM)NCT00274638	Phase 4	Completed	Boehringer Ingelheim	805	2002-07
Randomized, Double-Blind, Placebo-Controlled, Forced-Titration, Comparing Telmisartan vs Valsartan. Taken Orally for Eight Weeks in Patients With Stage 1 and Stage 2 Hypertension NCT00168779	Phase 4	Completed	Boehringer Ingelheim	1,185	2005-09 → 2006-07
Evaluation of Effect of Combination With Telmisartan and Hydrochlorothiazide in Hypertensives Uncontrolled on Amlodipine NCT00509470	Phase 4	Completed	Tokyo University	75	2007-07 → 2012-10
A Comparison of Telmisartan + Hydrochlorothiazide With Amlodipine + Hydrochlorothiazide in the Control of Blood Pressure in Older Patients With Predominantly Systolic Hypertension (ATHOS Study)NCT00240474	Phase 4	Completed	Boehringer Ingelheim	1,000	2002-12 → 2004-03
A Randomized, Double-blind, Placebo Controlled Comparison of Telmisartan Hydrochlorothiazide (HCT) and Valsartan HCT in Hypertension (HTN) Stage I/II Patients NCT00240448	Phase 4	Completed	Boehringer Ingelheim	1,109	2003-09
Safety Evaluation of Telmisartan Plus Hydrochlorothiazide in Patients With Mild-to-Moderate Hypertension NCT02177487	Phase 3	Completed	Boehringer Ingelheim	100	1999-06
Efficacy and Safety of TAH Combination in Comparison With Telmisartan/Amlodipine Combination for Essential Hypertension Patients NCT02738632	Phase 3	Completed	IlDong Pharmaceutical Co Ltd	300	2015-05 → 2016-08
3 x 3 Factorial Trial of Telmisartan and Hydrochlorothiazide in Patients With Essential Hypertension NCT00153049	Phase 2	Completed	Boehringer Ingelheim	583	2004-06 → 2005-06
Open-label Follow-up Trial of Fixed Dose Combination of Telmisartan + Hydrochlorothiazide in Hypertensive Patients NCT00267943	Phase 3	Completed	Boehringer Ingelheim	639	2006-01 → 2007-01
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

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

$4.48

per ea

Lowest NADAC/Unit

$4.48

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00597004337MICARDIS HCT 40-12.5 MG TABLET	$4.48	EA	Brand	$0.3713	2026-06-17
00597004437MICARDIS HCT 80-12.5 MG TABLET	$4.48	EA	Brand	$0.3488	2026-06-17
00597004237MICARDIS HCT 80-25 MG TABLET	$4.48	EA	Brand	$0.3536	2026-01-21

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 (3 FSS, 3 Big4)

Lowest Price

$104.97

Highest Price

$139.55

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00597-0044-37MICARDIS HCT 80/12.5MG TAB	$139.55	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0044-37MICARDIS HCT 80/12.5MG TAB	$104.97	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0042-37MICARDIS HCT 80/25MG TAB	$139.55	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0042-37MICARDIS HCT 80/25MG TAB	$104.98	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0043-37MICARDIS HCT 40/12.5MG TAB	$139.55	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0043-37MICARDIS HCT 40/12.5MG TAB	$104.97	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027

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

Medicare Part D Spending

CMS annual spending data for Micardis HCT (2024)

Total Spending

$786K

Total Claims

2,874

Beneficiaries

614

Avg Cost/Unit

$4.42

Spending Trend

$2.5M(2019)→$2.0M(2020)→$1.8M(2021)→$1.1M(2022)→$947K(2023)→$786K(2024)

YoY Change:-6.1%

5yr CAGR:-10.8%

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
Dec 21, 2022	SUPPL -47	View Letter (PDF)
Aug 21, 2020	SUPPL -45	View Letter (PDF)
Feb 2, 2018	SUPPL -40	View Letter (PDF)
Jan 14, 2016	SUPPL -32	View Letter (PDF)
Dec 15, 2014	SUPPL -37	View Letter (PDF)
Oct 26, 2012	SUPPL -35	View Letter (PDF)
Jan 23, 2012	SUPPL -34	View Letter (PDF)
Jan 23, 2012	SUPPL -30	View Letter (PDF)
May 6, 2011	SUPPL -29	View Letter (PDF)
May 6, 2011	SUPPL -31	View Letter (PDF)
Nov 25, 2009	SUPPL -20	View Letter (PDF)
Nov 25, 2009	SUPPL -19	View Letter (PDF)
Mar 6, 2007	SUPPL -16	View Letter (PDF)
Sep 8, 2005	SUPPL -8	View Letter (PDF)
Apr 29, 2004	SUPPL -5	View Letter (PDF)
Nov 17, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 12.5MG;40MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 17, 2000

No patent or exclusivity listings for this strength.

#002 — 12.5MG;80MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 17, 2000

#003 — 25MG;80MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 19, 2004