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	4,337,201*PED
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-001	Nov 30, 1994	5,006,344*PED
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-001	Nov 30, 1994	4,337,201*PED
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-001	Nov 30, 1994	4,384,123
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-002	Nov 30, 1994	5,006,344*PED
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-002	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
Germany	3169744
Netherlands	930144
Australia	549302
European Patent Office	0053902	PHOSPHINYLALKANOYL SUBSTITUTED PROLINES
Portugal	74079	PHOSPHINYLALKANOYL SUBSTITUTED PROLINES
Australia	7786081

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

Market Dynamics and Financial Trajectory for MONOPRIL-HCT

Last updated: August 2, 2025

Introduction

MONOPRIL-HCT, a fixed-dose combination of ramipril and hydrochlorothiazide, occupies a prominent position in the antihypertensive treatment landscape. Its formulation synergizes an ACE inhibitor with a thiazide diuretic, offering a dual mechanism for managing hypertension and reducing cardiovascular risk. This analysis examines the evolving market dynamics, competitive landscape, regulatory factors, and future financial trajectory of MONOPRIL-HCT, providing critical insights for stakeholders, investors, and pharmaceutical strategists.

Market Overview

Hypertension affects over 1.2 billion people worldwide, representing a lucrative and expanding market segment for antihypertensive agents[1]. Fixed-dose combinations (FDCs) like MONOPRIL-HCT appeal due to improved patient adherence, simplified regimens, and potentially enhanced efficacy.

The global antihypertensive drug market was valued at approximately $24 billion in 2022, with a compound annual growth rate (CAGR) of 4-5% projected through 2030[2]. Within this market, ACE inhibitors and thiazide diuretics constitute core therapeutic classes. MONOPRIL-HCT, marketed by various pharmaceutical firms (originally by AstraZeneca and later generic manufacturers), leverages these classes' extensive clinical use and established safety profiles.

Market Dynamics

1. Demand Drivers

• Rising Hypertension Prevalence: Increasing prevalence driven by aging populations, lifestyle factors, and urbanization intensifies demand[3]. Countries like China, India, and parts of Latin America experience surging hypertension rates, expanding the potential patient pool.

• Adherence and Simplification: Fixed-dose combination therapies like MONOPRIL-HCT improve adherence by reducing pill burden. Higher adherence correlates with better blood pressure control and fewer cardiovascular events, reinforcing the product’s clinical utility[4].

• Guideline Endorsements: Leading guidelines (e.g., JNC 8, ESC/ESH) recommend ACE inhibitors with diuretics for specific hypertensive populations, bolstering prescribing rates[5].

2. Competitive Landscape

• Generics and Patent Expiry: MONOPRIL-HCT’s original formulations face declining patent protection across key markets, leading to a proliferation of generic alternatives. Generics constitute over 70% of antihypertensive prescriptions in mature markets[6].

• New Fixed-Dose Combinations: Emerging combination therapies involving ARBs or other classes challenge MONOPRIL-HCT's market share. Patent protections for newer drugs (e.g., azilsartan-based FDCs) threaten its dominance.

• Brand vs. Generic: Brand name MONOPRIL-HCT commands premium pricing, but generics' entry exerts downward price pressure, impacting revenue margins for original manufacturers.

3. Regulatory Environment

• Approval Pathways: Monopril-HCT formulations have long-standing regulatory acceptance in major markets like the U.S., Europe, and Japan. However, evolving regulatory standards emphasize bioequivalence and safety, requiring ongoing compliance.

• Manufacturing and Quality Standards: Stringent Good Manufacturing Practice (GMP) standards influence manufacturing costs and supply stability, impacting profitability and market continuity.

4. Pricing and Reimbursement

• Pricing Strategies: Price sensitivity in both developed and emerging markets influences revenue. Governments and insurers increasingly favor cost-effective generics, squeezing margins on branded formulations.

• Reimbursement Policies: Reimbursement coverage directly impacts uptake; positive coverage accelerates adoption, especially in public healthcare settings.

5. Market Entry Barriers

• Supply Chain Constraints: Raw material availability, particularly for active pharmaceutical ingredients (APIs), can disrupt production.

• Patent Litigation and Exclusivity: Patent protections delay generic entry; once expired, market share shifts swiftly.

Financial Trajectory

1. Historical Performance

Recent data indicates that branded MONOPRIL-HCT experienced a decline in sales post-patent expiry, aligning with the global generic boom. Conversely, generic manufacturers have seen rapid sales growth, capturing significant market share[7].

2. Forecasting Future Revenue

• Increased Generic Adoption: As patents lapse, sales are expected to decline for branded versions but rebound through volume sales of generics.

• Emerging Market Opportunities: Growth in hypertension prevalence in Asia-Pacific and Latin America offers expansion avenues, albeit at lower price points.

• Pipeline and Formulation Innovations: Incorporation into combination regimens with newer antihypertensive agents or reformulation into once-daily dosing could rejuvenate interest.

3. Profitability Outlook

Original patent holders face margin erosion; however, diversification into biosimilars, biosimilar-like formulations, or novel combination variants can mitigate revenue decline[8].

• Cost Reduction: Manufacturing efficiencies and sourcing strategies can offset competitive price pressures.

• Pricing Strategies: Tiered pricing aligned with market income levels maximizes revenue while maintaining market share.

4. Potential Risks

• Market Saturation: Once generics dominate, incremental revenue may plateau.

• Regulatory Challenges: Stringent approval processes for reformulated or new combinations pose hurdles.

• Competitive Innovation: Faster de-risking and innovation by competitors threaten existing market positioning.

Strategic Implications

Stakeholders must adopt a dual approach: defend existing market share through lifecycle management and innovation, while exploring untapped markets and formulations. Alliances with emerging market manufacturers, investment in formulation development, and adherence to evolving regulatory standards are critical.

Key Takeaways

• Market growth is driven primarily by hypertension prevalence and improved adherence through fixed-dose combinations.
• Patent expiries prompt a shift from branded to generic formulation sales, significantly impacting revenue trajectories.
• Emerging markets present substantial growth opportunities, albeit at lower profit margins.
• Innovative formulations, new combination therapies, and pipeline development are vital to counteract market saturation.
• Regulatory compliance, supply chain resilience, and strategic pricing are crucial for sustained profitability.

FAQs

1. How does patent expiration affect MONOPRIL-HCT sales?
Patent expiry typically leads to a sharp decline in branded sales as generic equivalents enter the market, forcing original manufacturers to compete primarily on price or innovate with new formulations.

2. What are the key competitors to MONOPRIL-HCT?
Generic versions of ramipril and hydrochlorothiazide, along with newer fixed-dose combinations involving ARBs or calcium channel blockers, represent primary competition.

3. Can MONOPRIL-HCT regain market share through reformulation?
Potentially, reformulation into once-daily fixed-dose regimens with additional drug classes or novel delivery systems could renew market interest and extend patent life.

4. What role do regulatory policies play in the future of MONOPRIL-HCT?
Stringent bioequivalence and safety standards, along with approval pathways for combination therapies, influence product standing and market viability.

5. What are the prospects of MONOPRIL-HCT in emerging markets?
High hypertension prevalence and cost-sensitive healthcare systems favor generic absorption, offering growth prospects despite lower margins.

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References

[1] World Health Organization. Hypertension Fact Sheet. 2022.

[2] MarketsandMarkets. Antihypertensive Drugs Market Report. 2023.

[3] Kearney PM, et al. Global Burden of Hypertension. Lancet. 2021.

[4] Osterberg L, et al. Adherence to Medication. N Engl J Med. 2005.

[5] James PA, et al. 2014 Evidence-Based Guideline for the Management of High Blood Pressure. JAMA. 2014.

[6] IMS Health. The Impact of Generics on Pharmacoeconomics. 2022.

[7] IQVIA. Global Cardiovascular Therapeutics Market Analysis. 2023.

[8] Deloitte. Biopharma Innovation and Competitive Strategy. 2022.