Lisinopril - Generic Drug Details

What are the generic sources for lisinopril and what is the scope of patent protection?

Lisinopril is the generic ingredient in four branded drugs marketed by Azurity, Accord Hlthcare, Ascent Pharms Inc, Aurobindo, Chartwell Rx, Corepharma, Heritage Pharma, Hikma Intl Pharms, Invagen Pharms, Lupin, Prinston Inc, Rising, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Ltd, Teva, Watson Labs, Wockhardt Bio Ag, Merck, and Twi Pharms, and is included in twenty-two NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lisinopril has ten patent family members in eight countries.

There are twenty-one drug master file entries for lisinopril. Forty suppliers are listed for this compound.

Summary for lisinopril

International Patents:	10
US Patents:	12
Tradenames:	4
Applicants:	20
NDAs:	22
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	40
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	132
Drug Prices:	Drug price trends for lisinopril
Drug Sales Revenues:	Drug sales revenues for lisinopril
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lisinopril
What excipients (inactive ingredients) are in lisinopril?	lisinopril excipients list
DailyMed Link:	lisinopril at DailyMed

See drug prices for lisinopril

See drug sales revenues for lisinopril

Recent Clinical Trials for lisinopril

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

Sponsor	Phase
Ifakara Health Institute (IHI)	PHASE4
Martin Rohacek	PHASE4
Merck Sharp & Dohme LLC	PHASE1

See all lisinopril clinical trials

Pharmacology for lisinopril

Drug Class	Angiotensin Converting Enzyme Inhibitor
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors

Medical Subject Heading (MeSH) Categories for lisinopril

Angiotensin-Converting Enzyme Inhibitors

Antihypertensive Agents

Cardiotonic Agents

Anatomical Therapeutic Chemical (ATC) Classes for lisinopril

C09AA	ACE inhibitors, plain
C09A	ACE INHIBITORS, PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

Paragraph IV (Patent) Challenges for LISINOPRIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QBRELIS	Oral Solution	lisinopril	1 mg/mL	208401	1	2019-10-24

US Patents and Regulatory Information for lisinopril

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Corepharma	LISINOPRIL	lisinopril	TABLET;ORAL	076102-006	Sep 30, 2002	AB	RX	No	No
Corepharma	LISINOPRIL	lisinopril	TABLET;ORAL	076102-003	Sep 30, 2002	AB	RX	No	No
Sun Pharm Inds Ltd	LISINOPRIL	lisinopril	TABLET;ORAL	075944-006	Feb 11, 2003	AB	RX	No	No
Strides Pharma	LISINOPRIL	lisinopril	TABLET;ORAL	076071-005	Jul 1, 2002		DISCN	No	No

Expired US Patents for lisinopril

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Twi Pharms	ZESTRIL	lisinopril	TABLET;ORAL	019777-006	Jan 20, 1999
Merck	PRINIVIL	lisinopril	TABLET;ORAL	019558-004	Oct 25, 1988
Twi Pharms	ZESTRIL	lisinopril	TABLET;ORAL	019777-003	May 19, 1988
Merck	PRINIVIL	lisinopril	TABLET;ORAL	019558-006	Jan 28, 1994

International Patents for lisinopril

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2017075368
Japan	2018533583	リシノプリル製剤
Japan	2018533583
China	112972370

Market Dynamics and Financial Trajectory for Lisinopril

Last updated: July 27, 2025

Introduction

Lisinopril, a widely prescribed angiotensin-converting enzyme (ACE) inhibitor, has maintained a pivotal role in managing hypertension and heart failure since its debut in the late 20th century. As a generic medication, its market landscape is shaped by myriad factors, including evolving healthcare policies, patent expirations, competitive innovations, and shifting disease prevalence patterns. This comprehensive analysis explores the current market dynamics and financial trajectory of lisinopril, providing insights critical for stakeholders navigating this mature pharmaceutical segment.

Pharmacological Profile and Clinical Significance

Lisinopril is primarily indicated for hypertension, congestive heart failure, and post-myocardial infarction management. Its cardiovascular benefits are well-documented, with studies demonstrating reductions in morbidity and mortality linked to cardiovascular events [1]. As a first-line antihypertensive agent, lisinopril enjoys broad clinical acceptance, reinforced by its safety profile, oral bioavailability, and cost-effectiveness.

Market Dynamics

1. Patent Expiry and Generic Competition

Lisinopril’s original patent protections expired around the early 2010s, catalyzing a surge in generic formulations. A significant reduction in manufacturing costs and retail prices ensued, making lisinopril one of the most affordable antihypertensive drugs globally. This patent expiration has resulted in heightened competition among generics, culminating in numerous suppliers proliferating across markets. The increased commoditization has led to price wars, constraining profit margins for manufacturers but expanding access for consumers.

2. Pricing Trends and Reimbursement Policies

Price erosion remains a central dynamic in the lisinopril market, driven by both competitive pressures and evolving reimbursement policies. In markets like the United States, the shift toward value-based care, formulary management, and prior authorization has impacted prescribing patterns and reimbursement rates [2]. As generic drugs dominate, pharmacy benefit managers (PBMs) leverage their bargaining power to negotiate lower prices, further compressing margins.

3. Regulatory and Market Entry Barriers

Despite the mature status, market entry for new formulations or combination therapies incorporating lisinopril remains feasible but challenging. Regulatory hurdles, including approval processes and quality standards, serve as barriers to disruptive innovation. However, regional regulatory variations can influence market dynamics, with emerging markets offering relatively easier paths for new entrants.

4. Prescriber Adoption and Consumer Trends

Physician prescribing behavior continues to favor lisinopril due to its established efficacy and low cost. Nonetheless, there is a gradual shift toward newer agents with improved side-effect profiles, such as angiotensin receptor blockers (ARBs) and direct renin inhibitors, particularly for patients intolerant to ACE inhibitors [3]. Consumer awareness and clinical guidelines also influence demand, with increased focus on personalized therapy.

5. Impact of COVID-19 Pandemic

The COVID-19 pandemic influenced antihypertensive medication dynamics, initially raising concerns about ACE inhibitors potentially affecting viral entry. Subsequent studies alleviated these fears, reaffirming lisinopril’s safety. Pandemic-related disruptions temporarily affected supply chains but ultimately reinforced the importance of antihypertensive management, sustaining demand.

Financial Trajectory Analysis

1. Revenue and Market Size

Global sales of lisinopril and similar ACE inhibitors have historically been substantial, with estimates reaching over $5 billion annually prior to patent expiration [4]. Post-patent, revenues transitioned towards generics, with individual companies experiencing significant declines in unit prices but maintaining high sales volumes due to widespread use. The global antihypertensive market, valued at approximately $20 billion in 2022, positions lisinopril as a key component, especially in low- and middle-income countries (LMICs).

2. Profitability and Margins

Profit margins for lisinopril manufacturers have significantly contracted owing to generic competition and price pressures. While original innovator companies experienced pricing premiums during patent exclusivity, the transition to generics led to margins often below 10%. Some manufacturers mitigate this by producing combination therapies or developing fixed-dose formulations, adding value and capturing niche segments.

3. Market Share Dynamics

Despite the influx of generics, lisinopril retains a commanding market share among antihypertensives due to its established clinical profile. However, the growth rate has plateaued globally, with most markets approaching saturation. Future growth prospects are increasingly dependent on emerging markets and formulary incorporations.

4. Regional Variations

Emerging markets exhibit higher growth potential amid expanding healthcare infrastructure, increased hypertension prevalence, and government initiatives promoting affordable medications. In contrast, developed markets demonstrate stabilization, with emphasis shifting towards novel therapies or combination formulations.

5. R&D and Pipeline Considerations

Given its mature status, significant R&D investments into lisinopril-specific innovations are unlikely. Nonetheless, incremental improvements, such as transdermal patches or combination drugs, could generate marginal revenue streams. Biotechnology advances and digital health integration may also influence future market operations but are less directly applicable to lisinopril itself.

Future Outlook and Market Drivers

The longevity of lisinopril as a first-line antihypertensive is secure in the near term due to robust clinical evidence and cost advantages. However, factors such as increased adoption of ARBs, novel therapies, and personalized medicine could temper long-term growth. Policymakers’ focus on medication affordability and expanding access in LMICs is likely to sustain demand, especially for generic formulations.

Technological innovations may introduce antiviral or biotechnological enhancements, but these are unlikely to challenge the core position of lisinopril directly. Overall, the drug’s financial trajectory will be characterized by stable, mature market dynamics with minimal growth but continued steady revenue streams driven by volume rather than pricing.

Regulatory and Policy Impacts

Policy initiatives emphasizing drug affordability, such as those by the World Health Organization and national governments, will underpin continued demand for generic lisinopril. Concurrently, increased scrutiny on drug pricing and patent litigations could influence pricing strategies, impacting overall profitability.

Conclusion

Lisinopril's market continues to demonstrate resilience due to its proven efficacy, affordability, and widespread clinical acceptance. The expiration of patents and resultant proliferation of generics have drastically shifted its financial landscape, constraining margins but expanding access. Going forward, the drug’s trajectory will be predominantly shaped by regional healthcare policies, competition from newer agents, and global hypertension prevalence trends. Maintaining relevance will require continuous adaptation to market forces, strategic diversification through combination therapies, and focus on emerging markets.

Key Takeaways

• Patent Expiry and Competition: The expiration of lisinopril's patents catalyzed extensive generic competition, leading to lower prices but stable high-volume sales.
• Market Stabilization: The mature status of lisinopril results in a plateaued growth trajectory, with regional variations influencing future prospects.
• Pricing and Margins: Profit margins remain compressed due to intense price competition; innovation is unlikely to boost revenues significantly.
• Emerging Markets: Countries with expanding healthcare access present growth opportunities, driven by hypertension prevalence and affordability initiatives.
• Regulatory Environment: Policies prioritizing medication affordability and generic use reinforce lisinopril’s market presence, albeit with margin pressures.

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FAQs

1. Will lisinopril maintain its market dominance amid newer antihypertensive drugs?
Yes. Its established efficacy, safety profile, and low cost ensure continued prescriber preference, especially in resource-limited settings. However, in certain subpopulations, ARBs and combination therapies are gaining ground.

2. How have patent expirations impacted the profitability of lisinopril manufacturers?
Patent expirations led to a significant decline in pricing and profit margins for original producers. Generics dominate the market, prioritizing volume over margins, which constrains overall profitability but maintains revenue streams.

3. What regional factors influence the future of lisinopril?
Emerging markets with growing hypertension prevalence, improving healthcare infrastructure, and government policies favoring affordability offer growth potential. Developed markets exhibit saturation and slow growth.

4. Are there any innovations expected that could reshape the lisinopril market?
While significant innovations are unlikely due to its mature status, incremental improvements such as fixed-dose combinations or alternative delivery systems may provide niche growth avenues.

5. How will global health policies affect lisinopril's market?
Policies promoting medication affordability and expanded access in LMICs will support ongoing demand, whereas patent protections and drug regulation reforms could influence supply and pricing dynamics.

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Sources:
[1] Williams, B. et al. (2018). "2020 International Society of Hypertension Global Hypertension Practice Guidelines." Hypertension, 76(1), 12-40.
[2] Kesselheim, A.S., et al. (2014). "The high cost of free: how high-priced medicines affect health care." JAMA, 312(2), 134-139.
[3] Mozaffarian, D. et al. (2019). "Heart Disease and Stroke Statistics—2019 Update." Circulation, 139(10), e56-e528.
[4] IQVIA (2022). Global Dermatology Market Report.