QBRELIS Drug Patent Profile

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

Qbrelis is a drug marketed by Azurity and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

This drug has ten patent family members in eight countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Qbrelis

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

Summary for QBRELIS

International Patents:	10
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	2
Drug Prices:	Drug price information for QBRELIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QBRELIS
What excipients (inactive ingredients) are in QBRELIS?	QBRELIS excipients list
DailyMed Link:	QBRELIS at DailyMed

See drug prices for QBRELIS

Recent Clinical Trials for QBRELIS

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2
St. Jude Children's Research Hospital	Phase 2
Mayo Clinic	Phase 2

See all QBRELIS clinical trials

Pharmacology for QBRELIS

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

Paragraph IV (Patent) Challenges for QBRELIS

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 QBRELIS

QBRELIS is protected by twenty-nine US patents.

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	12,186,360		Y
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes	12,128,083		Y
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes	9,616,096
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes	11,179,434		Y
Azurity	QBRELIS	lisinopril	SOLUTION;ORAL	208401-001	Jul 29, 2016		RX	Yes	Yes	10,406,199

International Patents for QBRELIS

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20180069907	리시노프릴 제제
China	112972370	赖诺普利制剂 (LISINOPRIL FORMULATIONS)
Japan	2018533583	リシノプリル製剤
China	108472252	赖诺普利制剂 (LISINOPRIL FORMULATIONS)
European Patent Office	3960156	FORMULATIONS DE LISINOPRIL (LISINOPRIL FORMULATIONS)

Market Dynamics and Financial Trajectory for QBRELIS

Overview of QBRELIS

QBRELIS is an oral solution of lisinopril, an angiotensin-converting enzyme (ACE) inhibitor, used for the treatment of hypertension, systolic heart failure, and reduction of mortality in patients with acute myocardial infarction[2][4].

Market Size and Growth

The global market for lisinopril, which includes QBRELIS, has been growing steadily. In 2023, the lisinopril market size was valued at $1.66 billion and is projected to grow to $1.76 billion in 2024 at a compound annual growth rate (CAGR) of 6.0%. By 2028, the market is expected to reach $2.26 billion, driven by a CAGR of 6.4% during the forecast period[3].

Drivers of Market Growth

Several factors are driving the growth of the QBRELIS market:

Increasing Prevalence of Hypertension and Cardiovascular Diseases

The rising prevalence of hypertension and cardiovascular diseases, particularly among the aging population, is a significant driver. These conditions are more common in older adults, and the global population is aging, leading to increased demand for effective treatments like QBRELIS[1][3].

Availability of Generic Versions

The availability of generic versions of lisinopril, including QBRELIS, has made the drug more accessible and cost-effective. This has improved patient adherence and expanded the market reach[3].

Innovations in Drug Delivery

Innovations in drug delivery systems, such as the oral liquid formulation of QBRELIS, have enhanced patient compliance and treatment efficacy. These advancements are particularly beneficial for patients who have difficulty swallowing tablets, a common issue among the elderly[2][3].

Expanding Healthcare Coverage

Increasing healthcare expenditures and expanding healthcare coverage in both developed and developing countries are enabling greater access to treatments like QBRELIS. This is particularly evident in regions like North America and Europe, where robust healthcare infrastructure supports early disease detection and improved patient management[1].

Market Segmentation

Geographic Markets

North America, particularly the U.S., has been the largest market for lisinopril, including QBRELIS, due to a large geriatric population, high disease burden, and extensive healthcare coverage. However, the Asia-Pacific region is expected to be the fastest-growing market in the forecast period, driven by a burgeoning population and increasing life expectancy[1][3].

Distribution Channels

Hospital pharmacies currently dominate the market, accounting for 55.6% of the share in 2023, due to their ability to handle complex drug regimens. However, retail pharmacies are projected to grow at a CAGR of 15.3% as CHF management shifts towards outpatient settings, making retail pharmacies more crucial for patient access[1].

Product Formulations

QBRELIS is available as an oral liquid solution, which is a preferred formulation for many patients, especially the elderly. This formulation offers ease of administration and improved bioavailability compared to traditional tablets. The tablets segment, however, still dominates the market with 38.2% of the revenue share in 2023, but the injection segment is anticipated to grow significantly due to the need for rapid onset of action in acute cases[1].

Competitive Landscape

ACE inhibitors, including QBRELIS, held the largest share of the congestive heart failure drugs market in 2023, with 28.6% of the market share. Angiotensin 2 receptor blockers (ARBs) are also significant competitors, offering an alternative for patients who cannot tolerate ACE inhibitors due to side effects like cough or angioedema[1].

Financial Trajectory

The financial trajectory for QBRELIS is positive, driven by the growing demand for effective treatments for hypertension and heart failure. Here are some key financial indicators:

• Market Size: The lisinopril market, which includes QBRELIS, is expected to grow from $1.66 billion in 2023 to $2.26 billion by 2028[3].
• Revenue Growth: The market is projected to grow at a CAGR of 6.4% from 2023 to 2028, indicating steady and consistent revenue growth[3].
• Regional Contribution: North America, particularly the U.S., contributes significantly to the revenue, but the Asia-Pacific region is expected to drive future growth[1][3].

Challenges and Considerations

While the market for QBRELIS is growing, there are several challenges and considerations:

• Side Effects: QBRELIS can cause symptomatic hypotension, renal function changes, and other side effects, which require close medical supervision[2][4].
• Drug Interactions: The use of QBRELIS with other drugs that affect the renin-angiotensin system (RAS) can increase the risk of hypotension, hyperkalemia, and changes in renal function[2].
• Regulatory Environment: The pharmaceutical industry is heavily regulated, and any changes in regulatory policies can impact the market dynamics and financial trajectory of QBRELIS[4].

Key Takeaways

• The market for QBRELIS is driven by the increasing prevalence of hypertension and cardiovascular diseases.
• Innovations in drug delivery and expanding healthcare coverage are key growth drivers.
• North America is the largest market, but the Asia-Pacific region is expected to grow rapidly.
• ACE inhibitors, including QBRELIS, dominate the congestive heart failure drugs market.
• The financial trajectory is positive, with a projected CAGR of 6.4% from 2023 to 2028.

FAQs

What is QBRELIS used for?

QBRELIS is an ACE inhibitor used for the treatment of hypertension, systolic heart failure, and reduction of mortality in patients with acute myocardial infarction[2].

What are the key drivers of the QBRELIS market?

The key drivers include the increasing prevalence of hypertension and cardiovascular diseases, availability of generic versions, innovations in drug delivery, and expanding healthcare coverage[1][3].

Which region is expected to be the fastest-growing market for QBRELIS?

The Asia-Pacific region is expected to be the fastest-growing market for QBRELIS due to its burgeoning population and increasing life expectancy[1][3].

What are the potential side effects of QBRELIS?

QBRELIS can cause symptomatic hypotension, changes in renal function, and other side effects, which require close medical supervision[2][4].

How does QBRELIS compare to other ACE inhibitors in the market?

QBRELIS, as an oral liquid solution, offers ease of administration and improved bioavailability, making it a preferred choice for many patients, especially the elderly[1][2].

What is the projected market size for lisinopril, including QBRELIS, by 2028?

The market size for lisinopril, including QBRELIS, is projected to reach $2.26 billion by 2028[3].

Sources

1. Grand View Research: Congestive Heart Failure Drugs Market Size Report, 2030.
2. QBRELIS: Dosing and Administration.
3. GII Research: Lisinopril Global Market Report 2024.
4. FDA: QBRELIS Label.