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 eleven 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-one suppliers are listed for this compound.

Summary for lisinopril

International Patents:	10
US Patents:	11
Tradenames:	4
Applicants:	20
NDAs:	22
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	41
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	129
Patent Applications:	7,495
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
Medical College of Wisconsin	Early Phase 1
University of Rochester	Early Phase 1
Wake Forest University Health Sciences	Phase 4

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
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes	9,463,183		Y
Aurobindo	LISINOPRIL	lisinopril	TABLET;ORAL	077622-002	Feb 22, 2006	AB	RX	No	No
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes	10,940,177		Y

Expired US Patents for lisinopril

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Twi Pharms	ZESTRIL	lisinopril	TABLET;ORAL	019777-002	May 19, 1988	4,374,829*PED
Merck	PRINIVIL	lisinopril	TABLET;ORAL	019558-006	Jan 28, 1994	4,374,829*PED
Merck	PRINIVIL	lisinopril	TABLET;ORAL	019558-004	Oct 25, 1988	4,374,829*PED

International Patents for lisinopril

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3368012	FORMULATIONS DE LISINOPRIL (LISINOPRIL FORMULATIONS)
China	112972370
China	108472252

Lisinopril Market Dynamics and Financial Trajectory

Introduction to Lisinopril

Lisinopril, an angiotensin-converting enzyme (ACE) inhibitor, is a widely used medication for treating hypertension, heart failure, and other cardiovascular conditions. Its mechanism of action involves relaxing blood vessels, lowering blood pressure, and improving blood flow to the heart.

Market Size and Growth Projections

The lisinopril market has been experiencing steady growth and is projected to continue this trend. As of 2023, the market size was valued at approximately USD 1.5 billion to USD 1.66 billion, depending on the source[2][5].

• By 2031, the market is expected to reach USD 2.26 billion to USD 3.17 billion, with a compound annual growth rate (CAGR) of 4.3% to 6.4%[1][2][3].

Key Drivers of Market Growth

Several factors are driving the growth of the lisinopril market:

Rising Prevalence of Hypertension and Cardiovascular Diseases

The increasing global burden of hypertension and cardiovascular diseases is a primary driver. Hypertension affects approximately 1.28 billion adults worldwide, and cardiovascular diseases are among the leading causes of mortality globally[2][3][5].

Generic Versions and Cost-Effectiveness

The availability of generic lisinopril has significantly enhanced its market penetration. Generic versions are more affordable, making them a viable option for patients, healthcare providers, and payers, especially in regions where cost considerations are crucial[2][3].

Growing Awareness and Early Diagnosis

Public awareness campaigns and healthcare initiatives focused on hypertension and cardiovascular diseases are leading to earlier diagnosis and intervention. This increased awareness expands the market as healthcare professionals prescribe lisinopril more frequently[3].

Combination Therapies

The development of combination therapies involving lisinopril offers a promising avenue for market growth. These therapies can address multiple aspects of cardiovascular health, improving treatment efficacy and patient adherence[3].

Aging Population

The growing geriatric population is more susceptible to hypertension and cardiovascular diseases, presenting a significant opportunity for the lisinopril market. As the population ages, the demand for effective treatments like lisinopril is expected to rise[2][3].

Market Segmentation

The lisinopril market is segmented based on several criteria:

Type

• Tablets
• Oral Solutions
• Generic
• Branded
• Combination therapies[1][3].

Application

• Hypertension
• Congestive Heart Failure
• Post-Myocardial Infarction
• Diabetic Nephropathy
• Cardiovascular Risk Reduction[1][3].

Geographical Regions

• North America
• Europe
• Asia-Pacific
• South America
• Middle-East and Africa[1][2][3].

Regional Analysis

North America

North America is currently the largest region in the lisinopril market, driven by the high prevalence of hypertension and cardiovascular diseases among the population[2][3].

Asia-Pacific

The Asia-Pacific region is expected to be the fastest-growing due to the increasing geriatric population and growing healthcare expenditure in the region[2][3].

Challenges and Restraints

Despite the growth, the lisinopril market faces some challenges:

Side Effects and Tolerability Issues

While lisinopril is generally well-tolerated, it can have side effects such as cough, dizziness, and increased potassium levels. These issues can affect patient adherence and overall market growth[3].

Competition from Newer Drugs

The emergence of newer antihypertensive medications could pose a challenge to the market dominance of lisinopril. However, lisinopril's established efficacy and affordability continue to make it a preferred choice[1][2].

Financial Trajectory

The financial trajectory of the lisinopril market is positive, driven by the factors mentioned above.

• Revenue Growth: The market is expected to grow from USD 1.66 billion in 2023 to USD 2.26 billion by 2028, with a CAGR of 6.4%[2].
• Cost-Effectiveness: The availability of generic versions of lisinopril enhances its market penetration and contributes to its financial growth[2][3].

Illustrative Statistics

• The World Health Organization reported that around 1.28 billion adults aged 30-79 worldwide had hypertension in 2023[2].
• According to the Centers for Disease Control and Prevention, the prevalence of coronary heart disease among adults aged 18 and over increased slightly from 4.6% in 2020 to 4.9% in 2021[2].
• Coronary artery disease (CAD) accounts for approximately 610,000 deaths annually in the U.S. and is the leading cause of mortality, highlighting the critical need for medications like lisinopril[5].

Expert Insights

"Lisinopril's established efficacy and affordability compared to newer drugs position it well in the market," notes a market research report. "The growing geriatric population, susceptible to hypertension, presents a significant opportunity for the lisinopril market"[1].

Key Takeaways

• The lisinopril market is driven by the rising prevalence of hypertension and cardiovascular diseases.
• Generic versions and cost-effectiveness are key factors in market growth.
• Growing awareness and early diagnosis, along with combination therapies, are expanding the market.
• The aging population and increasing healthcare expenditure in developing regions are significant opportunities.
• Despite challenges, lisinopril remains a preferred choice due to its tolerability and minimal side effects.

FAQs

What is the primary use of lisinopril?

Lisinopril is primarily used to treat high blood pressure and heart failure by relaxing blood vessels and improving blood flow to the heart.

What are the key drivers of the lisinopril market?

The key drivers include the rising prevalence of hypertension and cardiovascular diseases, the availability of generic versions, growing awareness and early diagnosis, and the development of combination therapies.

Which region is expected to grow the fastest in the lisinopril market?

The Asia-Pacific region is expected to be the fastest-growing due to the increasing geriatric population and growing healthcare expenditure.

What are the common side effects of lisinopril?

Common side effects include cough, dizziness, and increased potassium levels.

How is the lisinopril market segmented?

The market is segmented by type (tablets, oral solutions, generic, branded, combination therapies), application (hypertension, heart failure, etc.), and geographical regions.

Cited Sources:

1. Market Research Intellect: Lisinopril Sales Market Size, Scope And Forecast Report[1].
2. The Business Research Company: Lisinopril Global Market Report 2024[2].
3. Data Bridge Market Research: Global Lisinopril Market – Industry Trends and Forecast to 2031[3].
4. Global Market Insights: Lisinopril Market Size - Global Market Insights[5].