Carvedilol - Generic Drug Details

What are the generic sources for carvedilol and what is the scope of freedom to operate?

Carvedilol is the generic ingredient in four branded drugs marketed by Aurobindo Pharma, Beximco Usa, Chartwell Molecular, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hikma, Lupin, MLV, Mylan, Pliva Hrvatska Doo, Rubicon, Sandoz, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Taro, Teva, Zydus Pharms Usa Inc, Waylis Therap, Impax Labs Inc, and Sun Pharm Industries, and is included in twenty-one NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are thirty-seven drug master file entries for carvedilol. Forty-five suppliers are listed for this compound.

Summary for carvedilol

US Patents:	1
Tradenames:	4
Applicants:	20
NDAs:	21
Drug Master File Entries:	37
Finished Product Suppliers / Packagers:	45
Raw Ingredient (Bulk) Api Vendors:	145
Clinical Trials:	188
Patent Applications:	6,756
Drug Prices:	Drug price trends for carvedilol
Drug Sales Revenues:	Drug sales revenues for carvedilol
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for carvedilol
What excipients (inactive ingredients) are in carvedilol?	carvedilol excipients list
DailyMed Link:	carvedilol at DailyMed

See drug prices for carvedilol

See drug sales revenues for carvedilol

Recent Clinical Trials for carvedilol

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

Sponsor	Phase
VA Office of Research and Development	Phase 3
Tanta University	Early Phase 1
West China Hospital	N/A

See all carvedilol clinical trials

Pharmacology for carvedilol

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

Anatomical Therapeutic Chemical (ATC) Classes for carvedilol

C07AG	Alpha and beta blocking agents
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for carvedilol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Ltd	CARVEDILOL	carvedilol	TABLET;ORAL	076649-003	Sep 5, 2007	AB	RX	No	No
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-002	Sep 14, 1995	AB	RX	Yes	Yes
Zydus Pharms Usa Inc	CARVEDILOL	carvedilol	TABLET;ORAL	077614-004	Sep 5, 2007	AB	RX	No	No
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-004	May 29, 1997	AB	RX	Yes	No
Dr Reddys Labs Ltd	CARVEDILOL	carvedilol	TABLET;ORAL	076649-002	Sep 5, 2007	AB	RX	No	No
Aurobindo Pharma	CARVEDILOL	carvedilol	TABLET;ORAL	078332-004	Sep 5, 2007	AB	RX	No	No

Expired US Patents for carvedilol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-002	Sep 14, 1995
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-001	Sep 14, 1995
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-003	Sep 14, 1995
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-002	Sep 14, 1995
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-004	May 29, 1997
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-001	Sep 14, 1995

Carvedilol Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Carvedilol

Introduction

Carvedilol, a nonselective adrenergic blocker, has been a cornerstone in the treatment of heart failure, hypertension, and left ventricular dysfunction following myocardial infarction. The market for carvedilol is influenced by a complex interplay of factors, including demographic trends, regulatory environments, and competitive dynamics.

Market Size and Forecast

The carvedilol market is projected to experience significant growth over the next few years. The market size is expected to increase at a CAGR of 3 to 5 percent from its estimated valuation by 2031. This growth is driven by the expanding patient pool for cardiovascular diseases (CVDs) and the increasing awareness about cardiac health globally[1][4].

Drivers of the Market

Increasing Prevalence of Cardiovascular Diseases

The global rise in cardiovascular diseases, which are the leading cause of death worldwide, is a major driver for the carvedilol market. According to the World Health Organization, CVDs accounted for 17.9 million deaths in 2019, making them the primary factor boosting the demand for carvedilol[4].

Aging Population

The increase in the geriatric population also contributes significantly to the growth of the carvedilol market. Older adults are more prone to heart failure and hypertension, which are key indications for carvedilol[4].

Government Initiatives and R&D Spending

Government initiatives to improve awareness about cardiovascular diseases and increased R&D spending for innovative cardiovascular medicines are additional drivers. These efforts enhance the market's potential by promoting better treatment options and encouraging the development of new products[4].

Restraints of the Market

Rigorous Regulations

The pharmaceutical industry is heavily regulated, and the approval process for new medications is stringent. This regulatory environment can slow down the introduction of new carvedilol formulations and limit market growth[4].

Side Effects and Adverse Reactions

Carvedilol, like other cardiovascular medications, has potential side effects and adverse reactions. These can include severe hypotension, second or third-degree AV block, and other conditions that may necessitate caution or alternative therapies. These factors can hamper market growth by reducing patient compliance and physician prescriptions[5].

Patent Expirations

The patent expiration of several blockbuster medications, including some formulations of carvedilol, can lead to increased competition from generic versions. This competition can reduce the market share of branded carvedilol products[4].

Cost-Effectiveness and Financial Impact

Cost Savings and Life-Year Gains

Studies have shown that carvedilol is cost-effective in the treatment of heart failure. For instance, a study using a Markov model estimated that the cost per life-year saved for carvedilol was $29,477 and $12,799 under limited and extended benefits assumptions, respectively. This indicates that carvedilol not only improves survival rates but also offers significant cost savings over time[2].

Reduction in Healthcare Costs

Data from the US Carvedilol Heart Failure Trials Program suggest that carvedilol reduces the costs of cardiovascular-related inpatient care. Patients receiving carvedilol had lower estimated costs of inpatient care compared to those receiving placebo, highlighting the financial benefits of using carvedilol in heart failure treatment[3].

Regional Market Analysis

North America

North America, particularly the U.S., dominates the global carvedilol market due to higher awareness about cardiac problems and a larger patient pool. Canada also contributes significantly to the regional market[4].

Europe

European countries such as Germany, the U.K., Spain, Italy, and France are major markets for carvedilol. The region's well-established healthcare system and high awareness of cardiovascular diseases support the market's growth[4].

Asia Pacific

The Asia Pacific region is anticipated to grow rapidly in the next few years. The presence of R&D centers, less restrictive salaries, and the availability of trained personnel attract manufacturers to invest in this region. Increasing awareness about cardiovascular diseases also drives the market growth in Asia Pacific[4].

Key Players and Competitive Landscape

The global carvedilol market is characterized by the presence of several key players, including Novartis AG, AstraZeneca plc, GlaxoSmithKline plc, Bristol-Myers Squibb, Mylan N.V., Johnson & Johnson, Bayer AG, Merck & Co., Inc., Sanofi, and Ranbaxy. These companies adopt strategies such as mergers and acquisitions, product launches, and partnerships to maintain their market positions[4].

Mechanism of Action and Therapeutic Benefits

Carvedilol's unique mechanism of action, which includes nonselective beta-blocking and alpha-1 adrenergic receptor antagonist properties, provides therapeutic benefits beyond traditional beta blockers. It improves blood flow, reduces afterload, and has antioxidant effects, making it a preferred choice for treating heart failure and hypertension[5].

Pharmacokinetics and Administration

Carvedilol exhibits rapid absorption, extensive distribution into tissues, and significant first-pass metabolism. It is primarily excreted into the bile and eliminated via feces. Understanding its pharmacokinetics is crucial for optimizing therapeutic outcomes and managing potential side effects[5].

Off-Label Uses and Future Potential

Carvedilol has several off-label uses, including stable angina, atrial fibrillation, and prophylaxis against cirrhotic esophageal variceal bleeding. These additional indications expand its market potential and highlight its versatility as a therapeutic agent[5].

Regulatory and Clinical Trials Landscape

The regulatory landscape for carvedilol involves stringent clinical trials and approval processes. Key trials such as the COPERNICUS and COMET trials have established carvedilol's efficacy in reducing mortality and hospitalizations for heart failure. Ongoing research and new clinical studies continue to shape the market and expand carvedilol's therapeutic applications[5].

Conclusion

The carvedilol market is poised for significant growth driven by increasing prevalence of cardiovascular diseases, government initiatives, and R&D spending. While regulatory challenges and side effects present restraints, the cost-effectiveness and therapeutic benefits of carvedilol make it a valuable treatment option. Understanding the market dynamics, regional trends, and competitive landscape is crucial for stakeholders to navigate and capitalize on the opportunities in this market.

Key Takeaways

• The carvedilol market is expected to grow at a CAGR of 3 to 5 percent from 2023 to 2031.
• Increasing prevalence of cardiovascular diseases and the aging population are key drivers.
• Rigorous regulations and side effects are significant restraints.
• Carvedilol is cost-effective in treating heart failure, reducing healthcare costs.
• North America and Europe are major markets, with Asia Pacific showing rapid growth potential.
• Key players adopt strategies like mergers and acquisitions to maintain market positions.
• Carvedilol's unique mechanism of action provides therapeutic benefits beyond traditional beta blockers.

FAQs

Q: What are the primary indications for carvedilol?

A: Carvedilol is primarily indicated for the chronic therapy of heart failure with reduced ejection fraction (HFrEF), hypertension, and left ventricular dysfunction following myocardial infarction[5].

Q: How cost-effective is carvedilol in treating heart failure?

A: Carvedilol is highly cost-effective, with a cost per life-year saved estimated at $29,477 and $12,799 under different assumptions. It also reduces the costs of cardiovascular-related inpatient care[2][3].

Q: What are the off-label uses of carvedilol?

A: Carvedilol has off-label uses in stable angina, atrial fibrillation, and prophylaxis against cirrhotic esophageal variceal bleeding[5].

Q: Which regions dominate the global carvedilol market?

A: North America, particularly the U.S., and Europe are the dominant regions, with the Asia Pacific region showing rapid growth potential[4].

Q: What are the key factors driving the growth of the carvedilol market?

A: The growth is driven by the increasing prevalence of cardiovascular diseases, the aging population, government initiatives, and increased R&D spending for innovative cardiovascular medicines[4].

Sources

1. Market Research Intellect, "Carvedilol Market Size And Forecast".
2. PubMed, "Cost effectiveness of carvedilol for heart failure".
3. PubMed, "Cost-effectiveness results from the US Carvedilol Heart Failure Trials Program".
4. BioSpace, "Carvedilol Drug Market Analysis, Status and Business Outlook from 2021 to 2031".
5. NCBI Bookshelf, "Carvedilol - StatPearls".