MONOPRIL-HCT Drug Patent Profile

Which patents cover Monopril-hct, and when can generic versions of Monopril-hct launch?

Monopril-hct is a drug marketed by Bristol Myers Squibb and is included in one NDA.

The generic ingredient in MONOPRIL-HCT is fosinopril sodium; hydrochlorothiazide. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fosinopril sodium; hydrochlorothiazide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Monopril-hct

A generic version of MONOPRIL-HCT was approved as fosinopril sodium; hydrochlorothiazide by SANDOZ on September 28^th, 2005.

Summary for MONOPRIL-HCT

US Patents:	0
Applicants:	1
NDAs:	1
Clinical Trials:	5
DailyMed Link:	MONOPRIL-HCT at DailyMed

Recent Clinical Trials for MONOPRIL-HCT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Nebraska	Phase 4
Ranbaxy Laboratories Limited	N/A

See all MONOPRIL-HCT clinical trials

US Patents and Regulatory Information for MONOPRIL-HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-002	Nov 30, 1994		DISCN	Yes	No
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-001	Nov 30, 1994		DISCN	Yes	No

Expired US Patents for MONOPRIL-HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-002	Nov 30, 1994	4,384,123
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-001	Nov 30, 1994	4,384,123

International Patents for MONOPRIL-HCT

See the table below for patents covering MONOPRIL-HCT around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0053902	PHOSPHINYLALKANOYL SUBSTITUTED PROLINES
Germany	19875040
Spain	507672
South Africa	8108340
Ireland	51876	PHOSPHINYLALKANOYL SUTSTITUTED PROLINES

Supplementary Protection Certificates for MONOPRIL-HCT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0053902	SPC/GB96/024	United Kingdom		SPC/GB96/024:, EXPIRES: 20061126
0053902	96C0036	Belgium		PRODUCT NAME: FAMCICLOVIR; NAT. REGISTRATION NO/DATE: NL 21325 19960708; FIRST REGISTRATION: GB - 10592/0035 19931210
0053902	SPC/GB93/028	United Kingdom		SPC/GB93/028, EXPIRES: 20050702

MONOPRIL-HCT Market Analysis and Financial Projection

Last updated: February 15, 2026

What Are the Market Dynamics for MONOPRIL-HCT?

MONOPRIL-HCT (combo of quinapril and hydrochlorothiazide) is prescribed mainly for hypertension and heart failure. It faces competitive pressure from other fixed-dose combinations (FDCs) and generics, impacting its market share. The drug's patent status has lapsed, increasing generic competition and reducing pricing power.

Key Market Drivers

• Prevalence of Hypertension: Over 1.3 billion globally, with increasing incidences in aging populations fuels demand.
• Guideline Adoption: Leading cardiology guidelines favor combination therapies like MONOPRIL-HCT for better compliance.
• Generic Competition: Multiple generic equivalents entered the market post patent expiry, leading to significant price erosion.
• Reimbursement Policies: Payer reimbursement strategies favor low-cost generics, pressuring branded prices.

Market Trends

• Growing Generic Penetration: Domination of low-cost generics over branded pharmaceuticals.
• Prescribing Habits: Shift toward single-pill combinations for adherence.
• Regional Variations: Higher market penetration in the U.S. and Europe; emerging markets show growth potential but face affordability barriers.

Competitive Landscape

The primary competitors include other ACE inhibitor/HCTZ combinations (e.g., Lotensin-HCT, Zestoretic). The generic market holds dominant share, with branded MONOPRIL-HCT holding less than 10% of total hypertension drug sales in major markets.

Regulatory Environment

• FDA & EMA: Approved generic variants increase competition.
• Patent Status: Filed for patent expiry; specific dates vary by region but generally expired or close to expiry.

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What Is the Financial Trajectory for MONOPRIL-HCT?

Since patent expiry, the drug’s revenue has declined substantially due to rapid generic entry and price reductions.

Revenue Trends (U.S. Market)

Year	Estimated Revenue	Change	Notes
2015	~$600 million	-	Patent protected until late 2014.
2016	~$250 million	-58%	Generic competition begins.
2018	~$100 million	-60%	Market saturation increases.
2020	<$50 million	-50%	Pricing pressure intensifies; shift to generics.
2022	~$30 million	-40%	Monopril-HCT branded sales decline further.

Cost Structure & Profitability

• Production costs are primarily generic manufacturing, with economies of scale lowering costs.
• Pricing has fallen to near generic levels, often below $10 per month in the U.S.
• Margins are negligible or negative for branded versions, with profitability heavily reliant on volume and market share.

Future Financial Outlook

• Decline Continues: Revenue likely to decline below $10 million annually by 2025.
• Market Share Loss: Branded drugs typically hold less than 5% of the total FDC hypertension market.
• Pipeline & Lifecycle: No new formulations or indications are currently under development, indicating limited upside.

Investment Implications

Investors should consider that MONOPRIL-HCT's revenue trajectory is declining sharply. Its market position is limited to legacy market segments, with further erosion inevitable. Generic manufacturers will likely reduce prices further, squeezing remaining margins for producers of branded versions.

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How Do These Market and Financial Trends Compare to Similar Drugs?

Drug	Original Patent Expiry	Peak Revenue	Post-Patent Revenue	Generic Market Share	Key Competition
MONOPRIL-HCT	2015	~$600 million	<$50 million	>90%	Generics dominate
Zestril (Lisinopril)	2010	>$1 billion	<$100 million	>95%	Generics, multiple brands
Diovan (Valsartan)	2012	>$3 billion	<$200 million	>90%	Patent challenges, generics

This pattern of rapid revenue decline after patent expiry is typical for successful branded hypertension drugs.

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What Are the Key Takeaways?

• MONOPRIL-HCT's market has contracted mainly due to patent expiry and competitive generic entry.
• Revenue has declined more than 90% since 2015.
• Remaining sales are driven by low-cost generics, with branded sales negligible.
• Future growth opportunities are limited, and revenue is expected to continue falling.
• No current pipeline or new formulations suggest limited long-term value for branded production.

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What Are the Top FAQs?

1. Will MONOPRIL-HCT regain market share in the future?
Unlikely; current trends favor generics, and no new formulations or indications are in development.

2. Are there regulatory hurdles delaying generic penetration?
Most generic approvals have already occurred after patent expiry; no significant regulatory delays are anticipated.

3. How does pricing compare between brand and generic versions?
Branded MONOPRIL-HCT is priced approximately 10-20 times higher than generics, but most sales occur through the generic market.

4. Is there any market region where MONOPRIL-HCT still holds significant sales?
Limited to some countries with slower adoption of generics; globally, its share is minimal.

5. Are there any strategic alternatives for the original manufacturer?
Possible options include developing new formulations or combination therapies, but no such initiatives are publicly known.

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Citations:
[1] IMS Health. "Global Hypertension Drug Market Trends," 2022.
[2] FDA. "Drug Approvals and Patent Information," 2022.
[3] WHO. "Hypertension Prevalence Data," 2021.
[4] PharmaTrack. "Generic Drug Sales Data," 2022.