Viewing data from:

MICARDIS

NDA

TELMISARTAN | N020850 | 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Unichem Pharmaceuticals (USA), Inc. FDA-2025-P-7054 · 7 docket documents Unichem Pharmaceuticals (USA), Inc. filed this citizen petition requesting that the FDA determine whether MICARDIS (Telmisartan Tablets, 20 mg and 80 mg) under NDA N020850, held by Boehringer Ingelheim, was voluntarily withdrawn for safety or effectiveness reasons. The petitioner seeks confirmation	505(q)	2025-12-15	Granted	Unichem Pharmaceuticals (USA), Inc.

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

Clinical Trials

201 trials from ClinicalTrials.gov — 1 recruiting, 168 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia NCT02735707	Phase 3	Recruiting	UMC Utrecht	20,000	2016-04-11 → 2028-02
The Effect of Various Types of the Renin-angiotensin-aldosterone System Blockade on Proteinuria NCT01541267	Phase 4	Completed	Medical University of Gdansk	20	2009-12 → 2011-11
Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial NCT02699645	Phase 3	Completed	The George Institute	1,671	2017-09-28 → 2025-08-27
Trial of COVID-19 Outpatient Treatment in Individuals With Risk Factors for Aggravation NCT04356495	Phase 2/3	Completed	University Hospital, Bordeaux	412	2020-07-29 → 2021-10-22
The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Male Volunteers Volunteers NCT03247140	Phase 1	Completed	Jeil Pharmaceutical Co., Ltd.	40	2017-06-10 → 2017-11-27
Telmisartan With or Without Hydrochlorothiazide in Patients With Mild-to-moderate Hypertension NCT02177435	Phase 3	Completed	Boehringer Ingelheim	491	1999-02
Telmisartan Plus Hydrochlorothiazide in Subjects With Mild-to-moderate Hypertension Who Failed to Respond to Telmisartan Monotherapy NCT02177500	Phase 3	Completed	Boehringer Ingelheim	327	2000-01
Bioavailability of Lacidipine and Telmisartan Fixed Dose Combination Tablets Relative to Separate Tablets in Healthy Subjects NCT02209649	Phase 1	Completed	Boehringer Ingelheim	12	1999-10
CKD-828 (80/5mg) Pharmacokinetic Study NCT02250833	Phase 1	Completed	Chong Kun Dang Pharmaceutical	69	2014-09 → 2014-12
Telmisartan Plus Exercise to Improve Functioning in Peripheral Artery Disease NCT02593110	N/A	Completed	Northwestern University	114	2016-01-04 → 2022-06-15

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$104.93

Highest Price

$139.55

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00597-0040-37MICARDIS 40MG TAB	$139.55	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0040-37MICARDIS 40MG TAB	$104.93	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0041-37MICARDIS 80MG TAB	$139.55	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0041-37MICARDIS 80MG TAB	$108.03	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 (2024)

Total Spending

$1.4M

Total Claims

4,348

Beneficiaries

1,210

Avg Cost/Unit

$4.40

Spending Trend

$4.7M(2019)→$4.3M(2020)→$3.8M(2021)→$2.2M(2022)→$2.0M(2023)→$1.4M(2024)

YoY Change:-6.0%

5yr CAGR:-10.7%

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

API Supply Chain28 active DMFs18 inactive

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

CIPLA LTDTELMISARTAN USP

DMF 199872006

MATRIX PHARMACORP PRIVATE LTDTELMISARTAN USP

DMF 201092007

ALEMBIC PHARMACEUTICALS LTDTELMISARTAN USP

DMF 202852007

AMINO CHEMICALS LTDTELMISARTAN

DMF 208822007

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDTELMISARTAN USP

DMF 214662007

TAPI NL BVTELMISARTAN

DMF 221232008

ZYDUS LIFESCIENCES LTDTELMISARTAN USP

DMF 226892009

MSN PHARMACHEM PRIVATE LTDTELMISARTAN USP [ROUTE CODE - TM]

DMF 227312009

DR REDDYS LABORATORIES LTDTELMISARTAN (PROCESS-II) USP

DMF 234722010

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTDTELMISARTAN API

DMF 238292010

JUBILANT BIOSYS LTDTELMISARTAN

DMF 240522010

MACLEODS PHARMACEUTICALS LTDTELMISARTAN

DMF 245642011

TORRENT PHARMACEUTICALS LTDTELMISARTAN USP

DMF 247202011

APITORIA PHARMA PRIVATE LTDTELMISARTAN USP (NON-STERILE DRUG SUBSTANCE)

DMF 258102012

SHARON BIO MEDICINE LTDTELMISARTAN USP

DMF 261232012

MICRO LABS LTDTELMISARTAN USP

DMF 275382013

ALIVUS LIFE SCIENCES LTDTELMISARTAN USP (D297 PROCESS)

DMF 278042014

IPCA LABORATORIES LTDTELMISARTAN USP

DMF 279462014

TOPHARMAN SHANDONG CO LTDTELMISARTAN

DMF 283092014

HOLIDAY LABS MEXICO SA DE CVTELMISARTAN

DMF 317062017

UNICHEM LABORATORIES LTDTELMISARTAN USP

DMF 326212018

CHROMO LABORATORIES INDIA PRIVATE LTDTELMISARTAN USP

DMF 339892019

MANKIND PHARMA LTDTELMISARTAN USP

DMF 368072022

GLOCHEM INDUSTRIES PRIVATE LTDTELMISARTAN

DMF 387722023

VASUDHA PHARMA CHEM LTDTELMISARTAN USP

DMF 388402023

KP MANISH GLOBAL INGREDIENTS PVT LTDTELMISARTAN USP

DMF 398212024

CTX LIFESCIENCES PVT LTDTELMISARTAN USP

DMF 399262024

ZHEJIANG JINGSHENG PHARMACEUTICAL CO LTDTELMISARTAN

DMF 417562025

GLENMARK PHARMACEUTICALS LTDInactiveTELMISARTAN

DMF 187592005

DR REDDYS LABORATORIES LTDInactiveTELMISARTAN

DMF 197592006

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveTELMISARTAN

DMF 205712007

GLENMARK LIFE SCIENCES LTDInactiveTELMISARTAN USP

DMF 205752007

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveTELMISARTAN USP (NON-STERILE BULK)

DMF 223522008

CADILA PHARMACEUTICALS LTDInactiveTELMISARTAN

DMF 224432009

SEQUEL PHARMACHEM PRIVATE LTDInactiveTELMISARTAN EP

DMF 227682009

JIANGXI SYNERGY PHARMACEUTICAL CO LTDInactiveTELMISARTAN

DMF 242112010

TORRENT PHARMACEUTICALS LTDInactiveTELMISARTAN

DMF 243622010

IND SWIFT LABORATORIES LTDInactiveTELMISARTAN

DMF 244722011

LUPIN LTDInactiveTELMISARTAN USP

DMF 246382011

COSMA SPAInactiveTELMISARTAN

DMF 247032011

HETERO LABS LTDInactiveTELMISARTAN, USP (FORM A)

DMF 250292011

ZHEJIANG TIANYU PHARMACEUTICAL CO LTDInactiveTELMISARTAN METHYL ESTER

DMF 255522011

SIGNA SA DE CVInactiveTELMISARTAN USP/EP

DMF 257422012

DIVIS LABORATORIES LTDInactiveTELMISARTAN, USP

DMF 260282012

AMOLI ORGANICS PVT LTDInactiveTELMISARTAN USP

DMF 265362012

FDC LTDInactiveTELMISARTAN USP

DMF 318232017

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

Approval Letters

16 letters from Drugs@FDA

Date	Submission	Document
Dec 21, 2022	SUPPL -45	View Letter (PDF)
Feb 2, 2018	SUPPL -40	View Letter (PDF)
Dec 15, 2014	SUPPL -38	View Letter (PDF)
Oct 26, 2012	SUPPL -36	View Letter (PDF)
Sep 24, 2012	SUPPL -33	View Letter (PDF)
Jan 23, 2012	SUPPL -35	View Letter (PDF)
Jan 23, 2012	SUPPL -31	View Letter (PDF)
Jul 7, 2011	SUPPL -32	View Letter (PDF)
Nov 20, 2009	SUPPL -25	View Letter (PDF)
Nov 19, 2009	SUPPL -23	View Letter (PDF)
Nov 19, 2009	SUPPL -22	View Letter (PDF)
Mar 6, 2007	SUPPL -19	View Letter (PDF)
Sep 8, 2005	SUPPL -13	View Letter (PDF)
Apr 7, 2004	SUPPL -11	View Letter (PDF)
Oct 31, 2003	SUPPL -5	View Letter (PDF)
Nov 10, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 40MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 10, 1998

No patent or exclusivity listings for this strength.

#002 — 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 10, 1998

#003 — 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 4, 2000