Olmesartan Medoxomil

Treats hypertension. Sold as Benicar. Every FDA application for this active ingredient: 1 branded and 25 generic.

As of Nov 15, 2026, FDA lists 26 applications for Olmesartan Medoxomil (sold as Benicar), first approved Apr 25, 2002, with 1 new use approved and 0 published complete response letters.

First approved: Apr 25, 2002
Applications: 26
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $90.1M

Medicare Spending

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


Olmesartan Medoxomil	Part D	$77.0M	+11%	1,038,861
Benicar	Part D	$13.2M	-6%	3,492

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

OLMESARTAN MEDOXOMIL 20 MG TAB: $0.080 per unitGeneric · +4% in a year
OLMESARTAN MEDOXOMIL 40 MG TAB: $0.111 per unitGeneric · -7% in a year
OLMESARTAN MEDOXOMIL 5 MG TAB: $0.061 per unitGeneric · +7% in a year
BENICAR 20 MG TABLET: $12.32 per unitBrand · +9% in a year
BENICAR 40 MG TABLET: $17.24 per unitBrand · +10% in a year
BENICAR 5 MG TABLET: $10.13 per unitBrand · +10% in a year

Clinical Trials

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


Dalpiciclib Combined With Aromatase Inhibitors and Olmesartan as the First-line Treatment for HR+/HER2- Advanced Breast CancerHR+ / HER2- Advanced Breast Cancer · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Phase 2	Recruiting	Sep 9, 2026
Polypills Approach for Multiple Cardiovascular Risk FactorsHypertension, Dyslipidemia · China Medical University, China	Not applicable	Recruiting	Jul 1, 2026
A Study to Compare the Pharmacokinetics and Safety of the ATB-U101 and ATB-U1011+ATB-U1012 and ATB-1011+ATB-1012 in Healthy Caucasian ParticipantsDiabete Type 2, Hypertension · Autotelicbio	Phase 1	Not yet recruiting	May 15, 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
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
Reduction Efficacy of OLOMAX for Blood Pressure and Low-density Lipoprotein Cholesterol in Hypertensive Patients With DyslipidemiaHypertension, Dyslipidemias · Daewoong Pharmaceutical Co. LTD.	—	Active, not recruiting	Dec 21, 2022
Effect of Sacubitril/Valsartan on Cardiac Function in Hypertensive Patients Stratified by BMI: A Real World StudySacubitril/Valsartan, Hypertension · Beijing Friendship Hospital	—	Recruiting	Aug 12, 2022
Study to Evaluate the Effect of Improving Systolic BP and LDL-C Compared to Conventional Treatments and the Convenience of Taking Medication of Olostar TabHyperlipidemias, Hypertension · Daewoong Pharmaceutical Co. LTD.	—	Active, not recruiting	Jun 9, 2022

Applications

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


Apr 25, 2002	BenicarNDA 21286 · New molecular entity	Cosette	23	Marketed
Oct 26, 2016	Olmesartan MedoxomilANDA 78276	Rising	2	Discontinued
Apr 24, 2017	Olmesartan MedoxomilANDA 91079	Teva Pharms USA	0	Discontinued
Apr 24, 2017	Olmesartan MedoxomilANDA 202375	Torrent	1	Discontinued
Apr 24, 2017	Olmesartan MedoxomilANDA 203012	Alembic	1	Marketed
Apr 24, 2017	Olmesartan MedoxomilANDA 204798	Aurobindo Pharma	1	Marketed
Apr 24, 2017	Olmesartan MedoxomilANDA 204814	Macleods Pharms	1	Marketed
Apr 24, 2017	Olmesartan MedoxomilANDA 205192	Zydus Pharms	1	Marketed
Apr 24, 2017	Olmesartan MedoxomilANDA 205482	Jubilant Generics	1	Marketed
Apr 24, 2017	Olmesartan MedoxomilANDA 206763	Alkem Labs Ltd	0	Marketed
Apr 24, 2017	Olmesartan MedoxomilANDA 207662	Accord Hlthcare	0	Marketed
Apr 27, 2017	Olmesartan MedoxomilANDA 206631	Lupin	0	Discontinued
May 25, 2017	Olmesartan MedoxomilANDA 203281	Glenmark Pharms Ltd	2	Marketed
Jun 29, 2018	Olmesartan MedoxomilANDA 208130	Sciegen Pharms	1	Marketed
Jan 10, 2019	Olmesartan MedoxomilANDA 210552	Qilu	1	Marketed
Feb 22, 2019	Olmesartan MedoxomilANDA 211049	Sunshine	1	Marketed
Jul 18, 2019	Olmesartan MedoxomilANDA 207135	Pharmazone	1	Marketed
Sep 17, 2019	Olmesartan MedoxomilANDA 206372	Micro Labs	1	Discontinued
Apr 13, 2020	Olmesartan MedoxomilANDA 90237	Sandoz	0	Discontinued
May 18, 2020	Olmesartan MedoxomilANDA 208659	Adaptis	0	Marketed
Dec 2, 2022	Olmesartan MedoxomilANDA 206720	Prinston	0	Marketed
Jan 18, 2023	Olmesartan MedoxomilANDA 217399	Msn	0	Marketed
Jul 11, 2023	Olmesartan MedoxomilANDA 207480	Amneal	0	Discontinued
Jan 25, 2024	Olmesartan MedoxomilANDA 206227	Chartwell Rx	0	Marketed
Oct 31, 2024	Olmesartan MedoxomilANDA 205499	Hetero Labs Ltd V	0	Marketed
Nov 8, 2024	Olmesartan MedoxomilANDA 210682	Cadila Pharms Ltd	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