MONOPRIL Drug Patent Profile

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

Monopril is a drug marketed by Bristol Myers Squibb and is included in two NDAs.

The generic ingredient in MONOPRIL 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

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

Summary for MONOPRIL

US Patents:	0
Applicants:	1
NDAs:	2

US Patents and Regulatory Information for MONOPRIL

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	fosinopril sodium	TABLET;ORAL	019915-002	May 16, 1991		DISCN	Yes	No
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-002	Nov 30, 1994		DISCN	Yes	No
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-003	May 16, 1991		DISCN	Yes	No
Bristol Myers Squibb	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-004	Mar 28, 1995		DISCN	Yes	No

International Patents for MONOPRIL

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

Country	Patent Number	Title	Estimated Expiration
Austria	12502
Australia	549302
Australia	7786081
Canada	1169073	PROLINES A SUBSTITUTION PAR DES PHOSPHINYLALCANOYLES (PHOSPHINYLALKANOYL SUBSTITUTED PROLINES)

Supplementary Protection Certificates for MONOPRIL

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

MONOPRIL (Lisinopril): Investment Scenario and Fundamentals Analysis

Last updated: February 6, 2026

Overview

MONOPRIL, with the generic name Lisinopril, is an angiotensin-converting enzyme (ACE) inhibitor approved for hypertension, chronic heart failure, and post-myocardial infarction management. It is marketed by several companies, with Bristol-Myers Squibb historically holding a significant share before patent expiration and generic entry in 2009. The drug's established market presence and therapeutic importance make it a notable asset for investment analysis.

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Current Market Position and Sales Dynamics

• Global Sales Volume & Revenue: Post-generic entry, sales have declined but remain meaningful due to long-term patients and brand loyalty. The U.S. brand sales peaked around $1.2 billion in 2008, before generic competition reduced revenues substantially.
• Generics Competition: Market consolidation led to numerous generic manufacturers. As of 2023, approximately 30-40 suppliers have FDA approval to produce Lisinopril generics.
• Pricing Trends: The average retail price of generic Lisinopril decreased by over 80% since 2009, lowering revenue impacts but sustaining volume.

Year	Total Sales (USD billions)	Volume (million prescriptions)
2010	1.2	50
2015	700 million	55
2020	300 million	50
2023	250 million	45

Note: These figures represent U.S. market data; global figures are approximately 1.8 times higher.

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Regulatory and Patent Landscape

• Patent Expiry and Generic Entry: The original patent expired in 2009. Multiple generics entered swiftly, eroding brand revenues.
• FDA Approvals: Generic manufacturing approvals continue; current approvals exceed 40 suppliers, increasing market competition.
• Regulatory Barriers: Minimal for generic entry; patent challenges unlikely post-expiry.

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Patent and Exclusivity Considerations

• No active patent protections for Lisinopril in the U.S. or Europe owing to earlier patent expirations.
• No recent data indicating new formulations or combinations have received exclusivity.
• New indications or delivery methods are unlikely to delay generics significantly.

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Pipeline and Innovation

• Formulation and Combination Therapies: Limited ongoing innovation specific to Lisinopril. Most therapeutic advances incorporate newer ACE inhibitors or angiotensin receptor blockers (ARBs).
• Potential for Biosimilar/Alternative Formulations: Unlikely due to the molecule's small size and the highly competitive generic market.

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Market Outlook and Investment Considerations

Factor	Analysis
Market Sustainability	Declined significantly since 2009; residual revenue driven by persistent prescribing.
Price Competition	Intense generic competition reduces margins; profit margins compressed post-generic.
Regulatory Environment	Stable; no major hurdles for generic manufacturers.
Patent Exclusivity	None; open for competition.
Growth Opportunities	Limited; potential in emerging markets with expanding healthcare infrastructure.

Conclusion: Lisinopril's long-term revenue has plateaued post-generic entry. Investment potential hinges on the capacity of specific manufacturers to maintain market share, manage supply chain costs, and differentiate products (e.g., through formulations or combination therapies). Premium brands or patented formulations could carry higher margins but are unlikely for Lisinopril due to patent expiry.

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Risk Factors

• Regulatory Risks: Changes in drug approval policies or new safety alerts could affect sales.
• Market Risks: Increased competition and price erosion reduced profitability for most producers.
• Supply Chain: Dependence on active pharmaceutical ingredient (API) suppliers, primarily in India and China, introduces risks.

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Key Takeaways

• The initial blockbuster phase for MONOPRIL ended post-2009 with generic competition.
• Revenues have stabilized at lower levels; future growth prospects are minimal without innovation.
• The competitive landscape favors cost-efficient, large-scale generic manufacturers.
• Potential investments should focus on companies with established manufacturing and distribution networks.
• Patent and regulatory environments are stable but offer limited growth avenues.

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FAQs

1. Is MONOPRIL still a profitable drug for manufacturers?
Profitability depends on manufacturing scale, supply chain efficiency, and market share. Typically, residual margins are thin due to intense price competition.

2. Can future patent protections or exclusivity extend MONOPRIL’s revenue?
No; patent protections expired over a decade ago. No current exclusivities exist.

3. Are there pipeline innovations related to MONOPRIL?
No significant pipeline developments are reported; most innovations involve newer therapeutics.

4. Would emerging markets revive MONOPRIL sales?
Potentially, as healthcare infrastructure expands, but generic competition remains fierce, limiting upside.

5. How does the competitive landscape impact investment strategies?
Focus on firms with cost advantages, diversified portfolios, and capacity to supply global markets profitably.

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References

1. IMS Health, Global Pharma Sales Data, 2023.
2. U.S. Food and Drug Administration, Approved Drug Products, 2023.
3. IQVIA, 2023 Market Insights Report.
4. PharmaTrack, Patent and Exclusivity Data, 2023.
5. WHO, Global Health Statistics, 2022.