COREG CR Drug Patent Profile

Which patents cover Coreg Cr, and what generic alternatives are available?

Coreg Cr is a drug marketed by Waylis Therap and is included in one NDA. There is one patent protecting this drug and three Paragraph IV challenges.

This drug has twenty-four patent family members in fourteen countries.

The generic ingredient in COREG CR is carvedilol phosphate. There are thirty-seven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the carvedilol phosphate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Coreg Cr

A generic version of COREG CR was approved as carvedilol phosphate by SUN PHARM INDUSTRIES on October 25^th, 2017.

Summary for COREG CR

International Patents:	24
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	28
Patent Applications:	29
Drug Prices:	Drug price information for COREG CR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COREG CR
What excipients (inactive ingredients) are in COREG CR?	COREG CR excipients list
DailyMed Link:	COREG CR at DailyMed

See drug prices for COREG CR

See drug sales revenues for COREG CR

Pharmacology for COREG CR

Drug Class	alpha-Adrenergic Blocker beta-Adrenergic Blocker
Mechanism of Action	Adrenergic alpha-Antagonists Adrenergic beta1-Antagonists Adrenergic beta2-Antagonists

Paragraph IV (Patent) Challenges for COREG CR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COREG CR	Extended-release Capsules	carvedilol phosphate	10 mg and 20 mg	022012	1	2008-03-18
COREG CR	Extended-release Capsules	carvedilol phosphate	40 mg	022012	1	2007-12-21
COREG CR	Extended-release Capsules	carvedilol phosphate	80 mg	022012	1	2007-11-19

US Patents and Regulatory Information for COREG CR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-001	Oct 20, 2006	AB	RX	Yes	No	8,101,209*PED				Y
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-004	Oct 20, 2006	AB	RX	Yes	No	8,101,209*PED				Y
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-002	Oct 20, 2006	AB	RX	Yes	No	8,101,209*PED				Y
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-003	Oct 20, 2006	AB	RX	Yes	Yes	8,101,209*PED				Y

Expired US Patents for COREG CR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-004	Oct 20, 2006	RE40000*PED
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-002	Oct 20, 2006	6,022,562*PED
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-003	Oct 20, 2006	7,268,156*PED
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-004	Oct 20, 2006	6,022,562*PED
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-003	Oct 20, 2006	5,760,069*PED
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-001	Oct 20, 2006	7,268,156*PED

International Patents for COREG CR

See the table below for patents covering COREG CR around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2492060	SELS DE PHOSPATE DE CARVEDILOL ET/OU SOLVATES DE CELUI-CI, COMPOSITIONS ET/OU METHODES DE TRAITEMENT ASSOCIEES (CARVEDILOL PHOSPHATE SALTS AND/OR SOLVATES THEREOF, CORRESPONDINQ COMPOSITIONS, AND/OR METHODS OF TREATMENT)
Russian Federation	2197242	СПОСОБ СНИЖЕНИЯ СМЕРТНОСТИ В РЕЗУЛЬТАТЕ ЗАСТОЙНОЙ СЕРДЕЧНОЙ НЕДОСТАТОЧНОСТИ С ПРИМЕНЕНИЕМ КАРВЕДИЛОЛА (METHOD FOR DECREASING A LETHALITY RATE AS A RESULT OF A STATIC HEART FAILURE BY USING CARVEDILOL)
Norway	314830
China	103288714	Carvedilol phosphate salts and/or solvates thereof, corresponding compositions, and/or methods of treatment
Poland	321737
Spain	2140641

COREG CR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for COREG CR

Introduction to COREG CR

COREG CR, containing the active ingredient carvedilol, is a once-daily heart medication classified as a beta-blocker. It is used to treat conditions such as high blood pressure, heart failure, and heart attacks that have reduced the heart's pumping efficiency[3].

Market Growth Drivers

The global carvedilol drug market, which includes COREG CR, is poised for significant growth driven by several key factors:

Increasing Prevalence of Cardiovascular Diseases

Cardiovascular diseases (CVDs) are the leading cause of death worldwide, accounting for 17.9 million deaths annually. This high mortality rate, coupled with the rising incidence of CVDs, is a major driver for the carvedilol market[1][4].

Growing Cases of Hypertension

Hypertension affects over 1.28 billion adults globally, with two-thirds of these cases occurring in low- and middle-income countries. The increasing prevalence of hypertension is a significant factor driving the demand for carvedilol[1][4].

Rising Heart Failure Incidences

Heart failure, particularly congestive heart failure (CHF), is another key driver. CHF affects approximately 64.34 million people worldwide, resulting in substantial healthcare costs and lost productivity[4].

Unhealthy Lifestyles and Demographic Factors

Poor lifestyle choices, including high sugar intake, lack of exercise, stressful lifestyles, and consumption of processed foods, contribute to the increasing cases of hypertension and cardiovascular diseases. Additionally, the growing geriatric population is more susceptible to these conditions, further boosting market demand[1].

Geographical Market Analysis

The global carvedilol drug market is segmented into several regions:

Asia Pacific

This region is expected to witness noteworthy growth due to the increasing prevalence of hypertension and CVDs. In 2019, CVDs were the leading cause of mortality in Asia, accounting for 10.8 million deaths. The region's growing healthcare sector and increasing research and development activities also contribute to market growth[1][4].

North America

North America is anticipated to hold the largest market share during the forecast period. The high prevalence of heart-related diseases, hypertension, and obesity in this region, along with significant investments in R&D and the presence of key market players, drive this growth[1][4].

Segmentation by Application

The carvedilol drug market is segmented by application into:

High Blood Pressure

COREG CR is effective in lowering blood pressure and is particularly beneficial for patients with additional risk factors such as high cholesterol or high blood sugar[3].

Congestive Heart Failure (CHF)

The CHF segment is expected to hold a substantial market share due to the increasing prevalence of CHF. COREG CR helps in managing CHF by lowering the heart rate and improving the heart's pumping efficiency[1][4].

Ventricular Dysfunction and Other Conditions

COREG CR is also used to treat ventricular dysfunction and other heart-related conditions, further expanding its market scope[1][4].

Distribution Channels

The market is segmented by distribution channels into:

Hospitals

Hospitals are expected to hold a noteworthy market share due to the preference for treatment by highly skilled medical personnel and the large patient pool in these facilities[4].

Retail Pharmacies, Online Pharmacies, and Others

Retail and online pharmacies also play a significant role, especially with the increasing awareness and convenience of online healthcare services[4].

Financial Trajectory

The financial performance of the carvedilol drug market, including COREG CR, is robust and expected to grow significantly:

Market Size and Growth Rate

The market is projected to witness a lucrative growth rate between 2024 and 2036, driven by the increasing prevalence of cardiac diseases and hypertension[1][4].

Revenue Projections

The Asia Pacific region is expected to account for the largest revenue share by 2036, while North America will maintain a significant market share due to its high prevalence of heart-related diseases and efficient healthcare infrastructure[1][4].

Healthcare Expenditure

Global health spending has increased significantly, reaching $8.5 trillion in 2019, which is expected to further boost the market for carvedilol and other cardiovascular medications[4].

Challenges and Opportunities

While the market for COREG CR is growing, there are challenges and opportunities to consider:

Challenges

• The high cost of treating and managing cardiovascular diseases can be a barrier to access for some patients.
• The presence of generic alternatives can impact the market share of brand-name drugs like COREG CR[5].

Opportunities

• Increasing research and development in the healthcare sector offers opportunities for new and advanced medical technologies.
• Growing awareness about CVDs and hypertension among the general public can lead to higher demand for preventive and treatment medications[1][4].

Key Takeaways

• The carvedilol drug market, including COREG CR, is driven by the increasing prevalence of cardiovascular diseases and hypertension.
• The Asia Pacific and North America regions are key markets due to their high disease prevalence and advanced healthcare infrastructure.
• The market is segmented by application, with CHF being a significant segment.
• Hospitals and retail pharmacies are major distribution channels.
• The financial trajectory indicates significant growth, driven by increasing healthcare expenditure and R&D investments.

FAQs

What is COREG CR used for?

COREG CR is used to treat high blood pressure, heart failure, and heart attacks that have reduced the heart's pumping efficiency[3].

Why is the carvedilol drug market growing?

The market is growing due to the increasing prevalence of cardiovascular diseases, hypertension, and heart failure, along with rising healthcare expenditure and R&D investments[1][4].

Which region is expected to dominate the carvedilol drug market?

North America is expected to hold the largest market share, while the Asia Pacific region is anticipated to witness the most significant growth[1][4].

What are the main distribution channels for COREG CR?

The main distribution channels include hospitals, retail pharmacies, and online pharmacies[4].

How does COREG CR benefit patients with heart failure?

COREG CR helps in managing heart failure by lowering the heart rate and improving the heart's pumping efficiency, thereby reducing the risk of another heart attack and improving overall heart health[3].