Telmisartan

Sold as Micardis. Every FDA application for this active ingredient: 1 branded and 18 generic.

As of Nov 14, 2026, FDA lists 19 applications for Telmisartan (sold as Micardis), first approved Nov 10, 1998, with 1 new use approved and 0 published complete response letters.

First approved: Nov 10, 1998
Applications: 19
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $42.3M
First approved in the EU: Dec 11, 1998

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Telmisartan	Part D	$42.1M	+11%	388,178
Micardis	Part D	$193K	-86%	386

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

TELMISARTAN 20 MG TABLET: $0.110 per unitGeneric · +2% in a year
TELMISARTAN 40 MG TABLET: $0.153 per unitGeneric · -15% in a year
TELMISARTAN 80 MG TABLET: $0.178 per unitGeneric · +15% in a year

Approvals in the EU (EMA)

First approved in the EU 1 month after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Telmisartan Teva Pharma, genericTeva B.V. · Oct 3, 2011
Telmisartan Actavis, genericActavis Group PTC ehf · Sep 29, 2010
Tolura, genericKRKA tovarna zdravil d.d. Novo mesto · Jun 4, 2010
Telmisartan Teva, genericTeva B.V. · Jan 25, 2010 · withdrawn
MicardisBoehringer Ingelheim International GmbH · Dec 16, 1998
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)Bayer AG · Dec 16, 1998 · withdrawn
Pritor, new substanceBayer AG · Dec 11, 1998 · withdrawn

Clinical Trials

18 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Early Mineralocorticoid Receptor Antagonist Therapy for Low-Renin Essential HypertensionHypertension (HTN), Low-Renin Essential Hypertension · China National Center for Cardiovascular Diseases	Phase 4	Not yet recruiting	Nov 12, 2026
A Clinical Trial to Evaluate the Drug-drug Interactions of Co-administered 'HUC2-744-A' and 'HUC2-744-B' in Healthy Adult VolunteersDrug-drug Interactions · Huons Co., Ltd.	Phase 1	Not yet recruiting	Aug 25, 2026
Relying on Pharmacotherapy to Improve Motor Gains in Chronic Stroke SurvivorsStroke · Spaulding Rehabilitation Hospital	Early phase 1	Recruiting	May 15, 2026
Impact of Medically Supervised Performance-Enhancing Substances (PES) on Elite AthletesSafety and Impact of Medically Supervised Performance Enhancing Substance Usage in Healthy Elite Athletes · Enhanced Emirates Limited	Not applicable	Enrolling by invitation	May 6, 2026
Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)Chronic Kidney Disease, Type 2 Diabetes · Baylor Research Institute	Phase 4	Enrolling by invitation	Apr 23, 2026
Safety and Efficacy of HB-1 for Post-Traumatic Stress DisorderPTSD, Mental Illness · HB BioTech, LLC	Phase 2	Recruiting	Mar 30, 2026
Telmisartan for Prevention of Doxorubicin-Induced Cardiotoxicity in Breast Cancer PatientsBreast Cancer, Doxorubicin Induced Cardiomyopathy · Tanta University	Phase 1 / Phase 2	Not yet recruiting	Jan 27, 2026
Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort StudyPost-stroke Pneumonia · First Teaching Hospital of Tianjin University of Traditional Chinese Medicine	—	Not yet recruiting	Dec 4, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Nov 10, 1998	MicardisNDA 20850 · New molecular entity	Boehringer Ingelheim	21	Discontinued
Jan 8, 2014	TelmisartanANDA 78710	Chartwell Rx	4	Marketed
Jul 7, 2014	TelmisartanANDA 90032	Glenmark Pharms Ltd	4	Marketed
Jul 7, 2014	TelmisartanANDA 202130	Alembic	3	Marketed
Jul 7, 2014	TelmisartanANDA 202397	Mylan	5	Marketed
Jul 7, 2014	TelmisartanANDA 203171	Torrent	5	Marketed
Aug 26, 2014	TelmisartanANDA 203325	Zydus Pharms	3	Marketed
Nov 3, 2014	TelmisartanANDA 203867	Sandoz	3	Marketed
Sep 3, 2015	TelmisartanANDA 206511	Aurobindo Pharma	4	Marketed
Sep 8, 2015	TelmisartanANDA 204415	Amneal Pharms	2	Marketed
Oct 30, 2015	TelmisartanANDA 205150	Adaptis	5	Marketed
Apr 22, 2016	TelmisartanANDA 205901	Hetero Labs Ltd V	3	Discontinued
Aug 22, 2016	TelmisartanANDA 204164	Jubilant Generics	2	Marketed
May 3, 2017	TelmisartanANDA 207882	Prinston	4	Marketed
Jul 25, 2017	TelmisartanANDA 208605	Cadila Pharms Ltd	2	Marketed
Oct 3, 2017	TelmisartanANDA 207016	Micro Labs	3	Discontinued
Feb 19, 2019	TelmisartanANDA 207843	Hisun Pharm Hangzhou	0	Discontinued
Oct 15, 2024	TelmisartanANDA 218157	Mankind Pharma	0	Marketed
Jan 15, 2025	TelmisartanANDA 203986	Macleods Pharms	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA