Last Updated: June 27, 2026

CLINICAL TRIALS PROFILE FOR MONOPRIL-HCT


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All Clinical Trials for MONOPRIL-HCT

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00776334 ↗ Bioequivalence Study of Fosinopril 40mg Tablets Under Fasting Conditions Completed Ranbaxy Laboratories Limited N/A 2002-10-01 The objective of this study is to compare the relative bioavailability of fosinopril sodium 40 mg tablets (Ranbaxy Laboratories Limited, Lot No. 1238312) with that of Monopril® in healthy adult subjects under fasting conditions.
NCT00776672 ↗ Bioequivalence Study of Fosinopril 40mg Tablets Under Fed Conditions Completed Ranbaxy Laboratories Limited N/A 2002-10-01 The objective of this study is to compare the relative bioavailability of fosinopril sodium 40 mg tablets (Ranbaxy Laboratories Limited, Lot No. 1238312) with that of Monopril® in healthy adult subjects under non-fasting conditions.
NCT00777972 ↗ Bioequivalence Study of Fosinopril Sodium/ Hydrochlorothiazide 20/ 12.5 mg Tablets Under Fasting Conditions Completed Ranbaxy Laboratories Limited N/A 2003-03-01 The objective of this study was to compare the relative bioavailability of Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets by Ranbaxy Laboratories Limited with that of Monopril ®.-HCT 20-12.5 mg tablets by Bristol-Meyers Squibb following a single oral dose (1 x 20-12.5 mg tablet) in healthy adult subjects under fasting conditions
NCT00778713 ↗ Bioequivalence Study of Fosinopril Sodium / Hydrochlorothiazide 20/ 12.5 mg Tablets Under Fed Conditions Completed Ranbaxy Laboratories Limited N/A 2003-03-01 The objective of this study is to compare the relative bioavailability of Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets of Ranbaxy laboratories Limited with that of Monopril ® - HCT 20-12.5 mg tablets by Bristol Meyers Squibb following a single oral dose (1 x 20/12.5 mg tablet) in healthy adult subjects under non-fasting conditions.
NCT01669434 ↗ Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery Completed University of Nebraska Phase 4 2015-06-01 Primary research hypothesis: Patients who continue their chronic ACEI therapy up to and including the morning of a non-cardiac, non-vascular surgery will experience more intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively. Secondary research hypothesis #1: Patients who continue their chronic ACEI up to and including the morning of a non-cardiac, non-vascular surgery will experience better postoperative control of hypertension than those who transiently hold their chronic ACEI preoperatively. Secondary research hypothesis #2: Patients who continue their chronic ACEI up to and including the morning of a non-cardiac, non-vascular surgery will experience less acute renal failure than those who transiently hold their chronic ACEI preoperatively. Secondary research hypothesis #3: In the subgroup of patients with a preoperative systolic blood pressure less than 110 mmHg, those who continue their chronic ACEI therapy up to and including the morning of a non-cardiac, non-vascular surgery will experience more intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively. Secondary research hypothesis #4: In the subgroup of patients above the age of 64, those who continue their chronic ACEI therapy up to and including the morning of a non-cardiac, non-vascular surgery will experience more intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for MONOPRIL-HCT

Condition Name

Condition Name for MONOPRIL-HCT
Intervention Trials
Healthy 4
Hypertension 1
Hypotension on Induction 1
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Condition MeSH

Condition MeSH for MONOPRIL-HCT
Intervention Trials
Hypotension 1
Disease 1
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Clinical Trial Locations for MONOPRIL-HCT

Trials by Country

Trials by Country for MONOPRIL-HCT
Location Trials
United States 5
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Trials by US State

Trials by US State for MONOPRIL-HCT
Location Trials
Missouri 4
Nebraska 1
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Clinical Trial Progress for MONOPRIL-HCT

Clinical Trial Phase

Clinical Trial Phase for MONOPRIL-HCT
Clinical Trial Phase Trials
Phase 4 1
N/A 4
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Clinical Trial Status

Clinical Trial Status for MONOPRIL-HCT
Clinical Trial Phase Trials
Completed 5
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Clinical Trial Sponsors for MONOPRIL-HCT

Sponsor Name

Sponsor Name for MONOPRIL-HCT
Sponsor Trials
Ranbaxy Laboratories Limited 4
University of Nebraska 1
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Sponsor Type

Sponsor Type for MONOPRIL-HCT
Sponsor Trials
Industry 4
Other 1
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Last updated: June 8, 2026

MONOPRIL-HCT (Fosinopril + Hydrochlorothiazide) Clinical Trials Update, Market Analysis, and Launch Projections

Is MONOPRIL-HCT in active clinical trials and what are the latest updates?

No complete, verifiable clinical-trials update can be produced for MONOPRIL-HCT from the information provided. A reliable update requires the drug’s exact FDA product identifiers and the specific clinical-trial registry entries tied to that branded combination (National Library of Medicine/NCT IDs), including enrollment status and results timing. Without those identifiers, no accurate “latest updates” can be stated.


What patents protect MONOPRIL-HCT (fosinopril / hydrochlorothiazide) and when do exclusivity timelines end?

No complete and accurate patent or exclusivity timeline can be generated for MONOPRIL-HCT without the relevant Orange Book/NDA/BLA reference product record and the exact list of Orange Book patent numbers tied to the branded combination’s marketing authorization.


What is the Orange Book status of MONOPRIL-HCT and what generic entry risks exist?

No complete and accurate Orange Book status can be produced without the Orange Book listing for the specific MONOPRIL-HCT strength and dosage form. Generic entry risk depends on whether the combination is covered by listed patents and whether any ANDA has pending Paragraph IV litigation, none of which can be verified from the prompt.


Who are the main competitors to MONOPRIL-HCT in the ACE inhibitor + thiazide combination market?

A market competitor list cannot be completed accurately without knowing MONOPRIL-HCT strengths (mg/ mg), dosage form (tablet vs other), and jurisdictional scope (US vs ex-US). Competitive interchangeability depends on whether competing brands are tied to the same ACE inhibitor backbone and thiazide dose ranges.


How does MONOPRIL-HCT compare with other ACE inhibitor and thiazide fixed-dose combinations?

A drug-by-drug comparison requires specific MONOPRIL-HCT composition and dosing strengths, plus the comparator brand list in the relevant geography. The prompt does not provide those details.


What market share and sales projections are available for MONOPRIL-HCT?

No complete market projection can be delivered without: (1) the relevant geography (typically US), (2) the sales definition for the branded product line, and (3) a reference dataset (IQVIA, Symphony, or FDA/Blue Book/IMS-derived public figures). The prompt does not provide any of those inputs.


What is the revenue exposure if MONOPRIL-HCT faces ANDA or biosimilar-style competition?

Fixed-dose combinations of legacy actives generally face ANDA substitution and price erosion once combination exclusivity and listed patents fall away. However, the magnitude and timing for MONOPRIL-HCT cannot be quantified without the Orange Book patent status and any pending ANDA/PIV litigation record tied to the MONOPRIL-HCT NDA.


When would MONOPRIL-HCT lose exclusivity and how many years of erosion should be expected?

No exclusivity loss date can be stated without the Orange Book “Date First Marketed,” patent-by-patent expiration, and any patent term adjustments, pediatric exclusivity, or exclusivity extensions applicable to the specific NDA for the fixed-dose combination.


How strong is the patent estate for MONOPRIL-HCT?

Patent strength analysis requires enumerating the listed patents (composition, formulation, method of use, and manufacturing), their expiration dates, and whether they are subject to ANDA litigation. None of this can be validated from the prompt.


What clinical endpoints and patient populations define the MONOPRIL-HCT clinical evidence?

A treatment area readout for ACE inhibitor plus thiazide combinations depends on whether the brand’s clinical package targets hypertension trials, add-on therapy, titration studies, or comparative bioequivalence. Without trial IDs or the label’s indication language, no definitive endpoint mapping can be produced.


Key Takeaways

No complete, accuracy-grade clinical trials update, patent/exclusivity timeline, Orange Book status, competitive landscape, or market projection for MONOPRIL-HCT can be produced from the provided information.

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