PRINIVIL Drug Patent Profile

When do Prinivil patents expire, and what generic alternatives are available?

Prinivil is a drug marketed by Merck and is included in one NDA.

The generic ingredient in PRINIVIL is lisinopril. There are twenty-one drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the lisinopril profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Prinivil

A generic version of PRINIVIL was approved as lisinopril by ASCENT PHARMS INC on July 1^st, 2002.

Summary for PRINIVIL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	12
Drug Prices:	Drug price information for PRINIVIL
What excipients (inactive ingredients) are in PRINIVIL?	PRINIVIL excipients list
DailyMed Link:	PRINIVIL at DailyMed

See drug prices for PRINIVIL

Recent Clinical Trials for PRINIVIL

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

Sponsor	Phase
St. Jude Children's Research Hospital	Phase 2
Memorial Health University Medical Center	Phase 1
Centre Hospitalier Universitaire de Saint Etienne	Phase 4

See all PRINIVIL clinical trials

US Patents and Regulatory Information for PRINIVIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck	PRINIVIL	lisinopril	TABLET;ORAL	019558-006	Jan 28, 1994		DISCN	No	No
Merck	PRINIVIL	lisinopril	TABLET;ORAL	019558-003	Dec 29, 1987		DISCN	No	No
Merck	PRINIVIL	lisinopril	TABLET;ORAL	019558-001	Dec 29, 1987		DISCN	No	No
Merck	PRINIVIL	lisinopril	TABLET;ORAL	019558-002	Dec 29, 1987		DISCN	No	No
Merck	PRINIVIL	lisinopril	TABLET;ORAL	019558-004	Oct 25, 1988		DISCN	No	No

Expired US Patents for PRINIVIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	PRINIVIL	lisinopril	TABLET;ORAL	019558-004	Oct 25, 1988	4,374,829*PED
Merck	PRINIVIL	lisinopril	TABLET;ORAL	019558-006	Jan 28, 1994	4,374,829*PED
Merck	PRINIVIL	lisinopril	TABLET;ORAL	019558-003	Dec 29, 1987	4,374,829*PED
Merck	PRINIVIL	lisinopril	TABLET;ORAL	019558-002	Dec 29, 1987	4,374,829*PED
Merck	PRINIVIL	lisinopril	TABLET;ORAL	019558-001	Dec 29, 1987	4,374,829*PED

International Patents for PRINIVIL

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

Country	Patent Number	Title	Estimated Expiration
Canada	1275349	DERIVES D'ACIDE AMINIQUE (AMINO ACID DERIVATIVES)
Zimbabwe	24479	AMINO ACID DERIVATIVES AS ANTIHYPERTENSIVES
Slovenia	7913000	PROCESS FOR OBTAINING DERIVATIVES OF CARBOXYALKYLDIPEPTIDES
Morocco	18664
Yugoslavia	43533
Canada	1262684	DERIVES AMINOACIDES ASSOCIES A DES AGENTS DIURETIQUES (AMINOACID DERIVATIVES COMPOSITION IN ASSOCIATION WITH DIURETIC AGENTS)

PRINIVIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lisinopril (Prinivil)

Introduction to Lisinopril (Prinivil)

Lisinopril, marketed under the brand name Prinivil among others, is an angiotensin-converting enzyme (ACE) inhibitor used primarily to treat hypertension, heart failure, and diabetic kidney disease. Understanding the market dynamics and financial trajectory of lisinopril is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Size and Growth

The global lisinopril market has been experiencing steady growth. As of 2023, the market size was valued at approximately USD 226.46 million and is projected to reach USD 317.15 million by 2031, with a compound annual growth rate (CAGR) of 4.30% during the forecast period[1][5].

Forecast Period Insights

• Base Year: 2023
• Forecast Year: 2031
• Market Size (Base Year): USD 226.46 million
• Market Size (Forecast Year): USD 317.15 million
• CAGR: 4.30%[1].

Drivers of Market Growth

Rising Prevalence of Hypertension and Cardiovascular Diseases

The increasing global burden of hypertension and cardiovascular diseases is a significant driver for the lisinopril market. As lifestyles become more sedentary and dietary habits less healthy, the demand for antihypertensive medications like lisinopril continues to rise. This trend is particularly pronounced in aging populations where cardiovascular issues are more prevalent[1].

Generic Versions and Cost-Effectiveness

The availability of generic lisinopril at more affordable prices enhances its market penetration. Generic versions offer a cost-effective solution for patients, healthcare providers, and payers, contributing significantly to the widespread adoption of lisinopril, especially in regions where cost considerations are critical in healthcare decisions[1][5].

Opportunities for Market Expansion

Growing Awareness and Early Diagnosis

Increasing public awareness campaigns and healthcare initiatives focused on hypertension and cardiovascular diseases create opportunities for the lisinopril market. Early diagnosis and intervention not only improve patient outcomes but also expand the market as healthcare professionals prescribe lisinopril as a front-line treatment for hypertension[1].

Combination Therapies

The exploration and development of combination therapies involving lisinopril offer a promising avenue for market growth. Combining lisinopril with other cardiovascular medications or complementary therapeutic agents could provide synergistic effects, addressing multiple aspects of cardiovascular health and potentially improving treatment efficacy and patient adherence[1].

Restraints and Challenges

Side Effects and Tolerability Issues

Despite its efficacy, lisinopril is associated with side effects such as cough, dizziness, and increased potassium levels, which can affect patient adherence and overall market growth. Managing these side effects and improving tolerability are critical challenges for pharmaceutical companies[1].

Market Segmentation

By Disease

The lisinopril market is segmented by disease, with hypertension expected to dominate due to the greater usage of lisinopril in controlling hypertension. Other segments include heart failure, heart attack, strokes, and diabetic kidney disease[1].

By Dosage and Dosage Strength

Lisinopril is available in various dosages, including tablets and liquids, with different dosage strengths such as 10mg/12.5mg, 20mg/12.5mg, and 20mg/25mg. These variations cater to different patient needs and contribute to the market's diversity[1].

By Brand

Key brands in the lisinopril market include Zestoretic, Prinivil, and Zestril. These brands have established market presence and contribute to the overall market size[1].

By Population Type and End-Users

The market is segmented by population type (children and adults) and end-users (hospitals, specialty clinics, home healthcare). This segmentation highlights the diverse user base and the various channels through which lisinopril is prescribed and consumed[1].

By Distribution Channel

The distribution channels for lisinopril include direct tender, hospital pharmacy, retail pharmacy, online pharmacy, and others. The rise of online pharmacies has expanded the reach of lisinopril, making it more accessible to a broader audience[1].

Financial Implications and Investment Strategies

Revenue and Profitability

The revenue from lisinopril is expected to grow significantly over the forecast period, driven by the increasing demand for antihypertensive medications. Pharmaceutical companies are likely to reinvest a portion of their profits into research and development to maintain a robust pipeline of future treatments[3].

Cost-Cutting and Mergers

The pharmaceutical industry, including companies involved in the lisinopril market, has been undergoing significant transformations. Cost-cutting measures and mergers are common strategies to maintain profitability. For instance, companies like Pfizer and Valeant have been leaders in cost-cutting and merger activities to enhance their financial positions[2].

Capital Allocation

Pharmaceutical companies must balance shareholder returns with reinvestment in the business. While share buybacks have been a short-term strategy to boost share prices, there is a growing need to reinvest in research and development to ensure long-term growth and competitiveness[2].

Impact of Generic Competition

The lisinopril market faces significant competition from generic versions, which are more affordable and widely available. This competition is expected to continue, influencing the market's financial trajectory. Despite this, the overall market is anticipated to grow due to the rising prevalence of hypertension and cardiovascular diseases[4].

Innovations and Patient-Centric Approaches

Innovations in drug delivery and patient-centric approaches are emerging trends in the lisinopril market. Companies are focusing on developing more effective and patient-friendly drug delivery methods, which could enhance market growth and patient adherence[5].

Key Players and Market Share

Major players in the lisinopril market include pharmaceutical companies that produce both branded and generic versions of the drug. Companies like Sun Pharmaceutical Industries Limited, which acquired Taro Pharmaceutical Industries Ltd, are expanding their portfolios to include lisinopril and other generic and specialty medicines[5].

Regional Market Analysis

The global lisinopril market is segmented geographically, with different regions experiencing varying growth rates. Developing countries, in particular, are expected to offer profitable opportunities due to increasing healthcare expenditure and growing awareness about cardiovascular diseases[1].

Regulatory Framework

The regulatory environment plays a crucial role in the lisinopril market. Pharmaceutical companies must comply with stringent regulations and guidelines set by health authorities to ensure the safety and efficacy of lisinopril. Changes in regulatory frameworks can impact market dynamics and the financial trajectory of the drug[1].

Patient Epidemiology and Pipeline Analysis

Patient epidemiology and pipeline analysis are essential for understanding the current and future market scenarios. The increasing prevalence of hypertension and cardiovascular diseases, coupled with a robust pipeline of new treatments, indicates a positive outlook for the lisinopril market[1].

Pricing Analysis

Pricing strategies are critical in the lisinopril market. The availability of generic versions has led to cost-effective options, which are attractive to both patients and healthcare providers. However, the pricing of branded versions remains a factor that influences market share and revenue[1].

"Drug companies must make significant profits on their best-selling drugs in one generation in order to reinvest in the next generation," highlighting the importance of profitability in driving future research and development[3].

Key Takeaways

• The global lisinopril market is expected to grow from USD 226.46 million in 2023 to USD 317.15 million by 2031, with a CAGR of 4.30%.
• The rising prevalence of hypertension and cardiovascular diseases is a primary driver for the market.
• Generic versions and cost-effectiveness are key factors in market penetration.
• Combination therapies and innovations in drug delivery are emerging trends.
• Side effects and tolerability issues remain significant challenges.
• Major players are expanding their portfolios through acquisitions and focusing on patient-centric approaches.

FAQs

What is the projected market size of lisinopril by 2031?

The global lisinopril market is projected to reach USD 317.15 million by 2031[1].

What are the primary drivers of the lisinopril market?

The primary drivers include the rising prevalence of hypertension and cardiovascular diseases, and the availability of generic versions at more affordable prices[1].

How does the availability of generic lisinopril impact the market?

The availability of generic lisinopril enhances market penetration by offering cost-effective solutions, which are attractive to patients, healthcare providers, and payers[1][5].

What are the emerging trends in the lisinopril market?

Emerging trends include the development of combination therapies and innovations in drug delivery to improve treatment efficacy and patient adherence[1][5].

How do side effects impact the lisinopril market?

Side effects such as cough, dizziness, and increased potassium levels can affect patient adherence and overall market growth, making it crucial to manage these side effects effectively[1].

Sources

1. Data Bridge Market Research: Global Lisinopril Market – Industry Trends and Forecast to 2031.
2. Mizuho Group: Restructuring the Pharmaceutical Industry Mizuho Industry Focus.
3. ITIF: The Link Between Drug Prices and Research on the Next Generation of Cures.
4. iHealthcareAnalyst: Global Antihypertensive Drugs Market $20.5 Billion by 2031.
5. GII Research: Lisinopril Global Market Report 2024.