Fosinopril Sodium

Sold as Monopril. Every FDA application for this active ingredient: 1 branded and 11 generic.

As of Nov 15, 2026, FDA lists 12 applications for Fosinopril Sodium (sold as Monopril), first approved May 16, 1991, with 2 new uses approved and 0 published complete response letters.

First approved: May 16, 1991
Applications: 12
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $3.8M

Medicare Spending

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

Product	Part	Spending, 2025	Change	Beneficiaries
Fosinopril Sodium	Part D	$3.8M	-3%	44,639

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

FOSINOPRIL SODIUM 10 MG TAB: $0.155 per unitGeneric · -6% in a year
FOSINOPRIL SODIUM 20 MG TAB: $0.160 per unitGeneric · -2% in a year
FOSINOPRIL SODIUM 40 MG TAB: $0.212 per unitGeneric · -1% in a year

Clinical Trials

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


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
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
NT-proBNP Selected Prevention of Cardiac Events in Diabetic PatientsHeart Diseases, Diabetes Mellitus, Type 2 · Martin Huelsmann	Phase 4	Recruiting	Jun 29, 2016

Applications

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


May 16, 1991	MonoprilNDA 19915 · New molecular entity	Bristol Myers Squibb	37	Discontinued
Nov 25, 2003	Fosinopril SodiumANDA 76139	Teva	2	Marketed
Apr 23, 2004	Fosinopril SodiumANDA 76483	Chartwell Rx	2	Marketed
Apr 23, 2004	Fosinopril SodiumANDA 76580	Ranbaxy Labs Ltd	0	Discontinued
Oct 8, 2004	Fosinopril SodiumANDA 76188	Upsher Smith Labs	1	Discontinued
Oct 15, 2004	Fosinopril SodiumANDA 76620	Actavis Labs Fl Inc	0	Discontinued
Dec 23, 2004	Fosinopril SodiumANDA 76987	Watson Labs	0	Discontinued
Apr 20, 2005	Fosinopril SodiumANDA 77222	Invagen Pharms	2	Marketed
May 17, 2005	Fosinopril SodiumANDA 76906	Apotex	3	Discontinued
Aug 31, 2006	Fosinopril SodiumANDA 77531	Watson Labs	0	Discontinued
Mar 30, 2011	Fosinopril SodiumANDA 91163	Aurobindo Pharma Ltd	1	Marketed
Aug 29, 2016	Fosinopril SodiumANDA 205670	Prinston	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