COREG Drug Patent Profile

Which patents cover Coreg, and when can generic versions of Coreg launch?

Coreg is a drug marketed by Waylis Therap and is included in two NDAs. There is one patent protecting this drug.

The generic ingredient in COREG 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

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

Summary for COREG

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	145
Patent Applications:	4,511
Drug Prices:	Drug price information for COREG
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COREG
What excipients (inactive ingredients) are in COREG?	COREG excipients list
DailyMed Link:	COREG at DailyMed

See drug prices for COREG

See drug sales revenues for COREG

Pharmacology for COREG

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

US Patents and Regulatory Information for COREG

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	carvedilol	TABLET;ORAL	020297-004	May 29, 1997	AB	RX	Yes	No
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-003	Oct 20, 2006	AB	RX	Yes	Yes	8,101,209*PED				Y
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-001	Sep 14, 1995	AB	RX	Yes	No

Expired US Patents for COREG

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-002	Sep 14, 1995	5,760,069*PED
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-001	Sep 14, 1995	5,760,069*PED
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-003	Sep 14, 1995	4,503,067*PED

International Patents for COREG

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

Country	Patent Number	Title	Estimated Expiration
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
Poland	321737

COREG Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: COREG (Carvedilol)

Introduction to COREG (Carvedilol)

COREG, known generically as carvedilol, is a beta-blocker prescribed for the treatment of heart failure, high blood pressure, and certain heart problems following a heart attack. This medication has been a cornerstone in cardiovascular therapy, and its market dynamics are influenced by several key factors.

Market Size and Growth Projections

The carvedilol drug market is poised for significant growth over the coming years. Projections indicate that the market will experience a substantial surge from 2023 to 2031, and further into 2036, driven by the increasing prevalence of cardiac diseases such as heart failure and hypertension[1][4].

Key Drivers of Market Growth

Increasing Prevalence of Cardiac Diseases

The rising cases of heart failure and hypertension globally are major drivers of the carvedilol market. According to the World Health Organization (WHO), cardiovascular diseases accounted for 32% of all deaths globally in 2019, with hypertension affecting over 1.28 billion adults aged 30-79 years worldwide[4].

Lifestyle Factors

Poor lifestyle choices, including high sugar intake, lack of exercise, stressful lifestyles, and consumption of processed foods, contribute significantly to the incidence of high blood pressure and cardiovascular diseases. These factors are expected to continue driving the demand for carvedilol[4].

Medical R&D and Advanced Technologies

The growth of the carvedilol market is also supported by increasing medical research and development, as well as the emergence of new and advanced medical technologies. These advancements enhance the efficacy and safety of carvedilol, making it a preferred treatment option[4].

Market Segmentation

The carvedilol drug market is segmented by application into high blood pressure, congestive heart failure (CHF), ventricular dysfunction, and others. The CHF segment is anticipated to hold a substantial share in the global market due to the increasing prevalence of CHF, which is often caused by fluid build-up in the heart and high levels of cholesterol[4].

Geographical Analysis

Geographically, the global carvedilol drug market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. The Asia Pacific region is expected to account for the largest revenue share by 2036, driven by the rising prevalence of hypertension in low and middle-income countries. North America is also anticipated to gain a significant revenue share due to the high prevalence of heart failure and high blood pressure, along with the presence of efficient healthcare infrastructure[4].

Cost-Effectiveness and Financial Impact

Cost Savings

Studies have shown that carvedilol is not only effective in reducing mortality in patients with heart failure but also cost-saving. Data from the US Carvedilol Heart Failure Trials Program indicate that patients randomized to receive carvedilol had lower estimated costs of cardiovascular-related inpatient care compared to those receiving a placebo. The estimated cost per death averted was negative, suggesting that carvedilol can both increase survival and decrease healthcare costs[2].

Market Pricing and Financial Assistance

The cost of carvedilol can vary based on factors such as treatment plans, insurance coverage, and the pharmacy used. However, it is generally available as a generic drug, which makes it more affordable compared to brand-name medications. Financial assistance programs and savings options are also available to help reduce the cost of prescriptions[5].

Competitive Landscape

The carvedilol market is competitive, with several pharmaceutical companies involved in its production and distribution. For instance, Avadel Pharmaceuticals has been involved in the development and commercialization of various pharmaceutical products, including those that could potentially compete with or complement carvedilol in the market[3].

Challenges and Opportunities

Challenges

Despite the positive market dynamics, there are challenges such as competitive market pressures and the potential for new drug approvals that could impact the market share of carvedilol. Additionally, the need for continuous medical R&D to maintain and improve the drug's efficacy and safety is a ongoing challenge[4].

Opportunities

The increasing prevalence of cardiac diseases and the growing need for effective and cost-efficient treatments present significant opportunities for the carvedilol market. Partnerships and acquisitions, such as those seen in the pharmaceutical industry, can also enhance market presence and revenue growth[3][4].

Regulatory Environment

The regulatory environment plays a crucial role in the carvedilol market. Approvals from regulatory bodies such as the FDA are essential for the commercialization of carvedilol and its formulations. The transition from unapproved to approved drug products, as seen in Avadel's strategy, can provide near-term revenue growth and cash flows to fund further R&D and inorganic initiatives[3].

Key Takeaways

• The carvedilol drug market is expected to experience significant growth from 2023 to 2036 driven by increasing cardiac diseases and lifestyle factors.
• The market is segmented by application, with CHF being a major segment.
• Geographically, the Asia Pacific and North America regions are expected to be key markets.
• Carvedilol is cost-effective and can reduce healthcare costs while improving patient outcomes.
• The competitive landscape includes several pharmaceutical companies, and regulatory approvals are crucial for market success.

FAQs

What is carvedilol used for?

Carvedilol, known by the brand name COREG, is used for the treatment of heart failure, high blood pressure, and certain heart problems following a heart attack.

Is carvedilol cost-effective?

Yes, carvedilol has been shown to be cost-effective. It reduces the estimated costs of cardiovascular-related inpatient care and can decrease overall healthcare costs while improving patient survival rates[2].

What are the key drivers of the carvedilol market growth?

The key drivers include the increasing prevalence of cardiac diseases such as heart failure and hypertension, lifestyle factors, and advancements in medical R&D and technologies[4].

Which regions are expected to dominate the carvedilol market?

The Asia Pacific and North America regions are anticipated to be the dominant markets for carvedilol due to the rising prevalence of hypertension and the presence of efficient healthcare infrastructure[4].

Is carvedilol available as a generic drug?

Yes, carvedilol is available as a generic drug, which makes it more affordable compared to brand-name medications. Financial assistance programs and savings options are also available to help reduce the cost of prescriptions[5].

Sources

1. Market Research Intellect: Carvedilol Drug Market Size, Scope And Forecast Report.
2. PubMed: Cost-effectiveness results from the US Carvedilol Heart Failure Trials.
3. Avadel Pharmaceuticals: AVADEL PHARMACEUTICALS PLC.
4. Research Nester: Carvedilol Drug Market Size, Growth Forecasts 2036.
5. Medical News Today: Carvedilol cost 2024: Coupons and more.