Carvedilol phosphate - Generic Drug Details

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

Carvedilol phosphate is the generic ingredient in two branded drugs marketed by Impax Labs Inc, Sun Pharm Industries, and Waylis Therap, and is included in three NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Carvedilol phosphate has twenty-four patent family members in fourteen countries.

There are nine drug master file entries for carvedilol phosphate. Ten suppliers are listed for this compound.

Summary for carvedilol phosphate

International Patents:	24
US Patents:	1
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	5
Patent Applications:	191
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for carvedilol phosphate
What excipients (inactive ingredients) are in carvedilol phosphate?	carvedilol phosphate excipients list
DailyMed Link:	carvedilol phosphate at DailyMed

Recent Clinical Trials for carvedilol phosphate

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

Sponsor	Phase
GlaxoSmithKline	Phase 1
University of Minnesota - Clinical and Translational Science Institute	Phase 1/Phase 2
University of Minnesota	Phase 1/Phase 2

See all carvedilol phosphate clinical trials

Pharmacology for carvedilol phosphate

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 phosphate

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

Paragraph IV (Patent) Challenges for CARVEDILOL PHOSPHATE

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 carvedilol phosphate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax Labs Inc	CARVEDILOL PHOSPHATE	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	204717-004	May 7, 2018	AB	RX	No	No
Sun Pharm Industries	CARVEDILOL PHOSPHATE	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	090132-001	Oct 25, 2017	AB	RX	No	No
Impax Labs Inc	CARVEDILOL PHOSPHATE	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	204717-001	May 7, 2018	AB	RX	No	No

Expired US Patents for carvedilol phosphate

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
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-002	Oct 20, 2006
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-003	Oct 20, 2006

International Patents for carvedilol phosphate

Country	Patent Number	Title	Estimated Expiration
France	2830447	FORME GALENIQUE ORALE MICROPARTICULAIRE POUR LA LIBERATION RETARDEE ET CONTROLEE DE PRINCIPES ACTIFS PHARMACEUTIQUES (Microparticulate oral formulation for controlled, retarded release of drug absorbed from upper gastrointestinal tract, having combination of pH dependent and time dependent release mechanisms to guarantee absorption)
Spain	2661723
Japan	4718116

Carvedilol phosphate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Carvedilol Phosphate

Introduction to Carvedilol Phosphate

Carvedilol phosphate, a phosphate salt form of carvedilol, is a non-selective adrenergic blocker used primarily for the management of heart failure, left ventricular dysfunction following myocardial infarction, and hypertension. Its antihypertensive and anti-heart failure properties make it a crucial medication in the cardiovascular disease (CVD) treatment landscape[3][5].

Market Growth Drivers

The carvedilol phosphate market is driven by several key factors:

Increasing Prevalence of Cardiovascular Diseases

The rising incidence of heart failure, hypertension, and other cardiovascular diseases is a significant driver. According to the World Health Organization (WHO), cardiovascular diseases accounted for 17.9 million deaths in 2019, representing 32% of all global deaths[1][4].

Growing Geriatric Population

The increase in the geriatric population contributes to the rise in CVD cases, as older adults are more prone to these conditions. This demographic shift is expected to boost the demand for carvedilol phosphate[4].

Lifestyle Factors

Poor lifestyle choices, including high sugar intake, lack of exercise, stressful lifestyles, and consumption of processed foods, are primary causes of high blood pressure and cardiovascular diseases. These factors are prevalent globally and drive the need for effective treatments like carvedilol phosphate[1][4].

Advancements in Medical R&D and Technologies

The emergence of new and advanced medical technologies, along with increased medical research and development, is expected to enhance the market growth of carvedilol phosphate. Collaborations between pharmaceutical companies and research institutions are also pivotal in this regard[1][4].

Market Segmentation

The global carvedilol phosphate market is segmented based on several criteria:

Application

The market is segmented into high blood pressure, congestive heart failure (CHF), ventricular dysfunction, and other applications. The CHF segment is anticipated to hold a substantial share due to the increasing prevalence of CHF, which is often caused by fluid build-up in the heart and high levels of cholesterol[1].

Geographical Analysis

The market is divided into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America is expected to maintain a significant revenue share due to the high prevalence of heart failure and hypertension, along with the presence of efficient healthcare infrastructure. The Asia Pacific region is projected to grow rapidly, driven by the rising prevalence of hypertension in low and middle-income countries[1][4].

Challenges and Restraints

Despite the growth drivers, the carvedilol phosphate market faces several challenges:

Rigorous Regulations

Stringent regulatory requirements for pharmaceuticals can hamper market growth. The difficult regulatory clearance process for new medications can delay market entry and impact overall sales[4].

Side Effects and Adverse Reactions

Carvedilol phosphate is associated with several side effects, including bradycardia, hypotension, heart failure/fluid retention, and non-allergic bronchospasm. These adverse reactions can lead to discontinuation of therapy and affect market growth[2][5].

Patent Expirations

The patent expiration of several blockbuster medications, including those related to carvedilol, can lead to increased competition from generic drugs, potentially restraining market growth[4].

Financial Trajectory

The financial trajectory of the carvedilol phosphate market is expected to be lucrative over the forecast period (2024-2036):

Market Size and Growth Rate

The market is poised to witness a significant growth rate, driven by the increasing prevalence of cardiac diseases and hypertension. The Asia Pacific region is likely to account for the largest revenue share by 2036, while North America will continue to be a major contributor due to its well-established healthcare infrastructure[1].

Key Players and Strategies

Major pharmaceutical companies such as Novartis AG, AstraZeneca plc, GlaxoSmithKline plc, and others are key players in the carvedilol phosphate market. These companies are adopting strategies like mergers and acquisitions, product launches, and partnerships to maintain their market positions. For example, Sun Pharmaceutical Industries Limited and Ferring Pharmaceuticals have collaborated on commercializing new formulations, which can impact market dynamics[1][4].

Regional Performance

North America

North America is expected to dominate the market due to high awareness about cardiac problems, efficient healthcare infrastructure, and a large patient pool suffering from heart failure and hypertension. The U.S. is the largest market in this region, followed by Canada[4].

Asia Pacific

The Asia Pacific region is anticipated to grow rapidly, driven by the rising prevalence of hypertension in low and middle-income countries. The availability of trained personnel and less restrictive salaries are attracting pharmaceutical companies to establish R&D centers in this region[1][4].

Innovative Developments and Off-Label Uses

Carvedilol has shown potential in off-label uses such as stable angina, atrial fibrillation, and ventricular arrhythmias. Researchers have also explored its use in skin-targeted administration to reduce UV-induced skin damage and carcinogenesis, highlighting its versatile therapeutic potential[4].

Key Takeaways

• The carvedilol phosphate market is driven by the increasing prevalence of cardiovascular diseases and hypertension.
• The market is segmented by application and geography, with CHF and North America being significant segments.
• Challenges include rigorous regulations, side effects, and patent expirations.
• The financial trajectory is expected to be lucrative, with the Asia Pacific region showing rapid growth.
• Key players are adopting strategies like mergers and acquisitions to maintain market leadership.

Frequently Asked Questions (FAQs)

Q1: What are the primary indications for carvedilol phosphate? Carvedilol phosphate is indicated for the management of heart failure, left ventricular dysfunction following myocardial infarction, and hypertension[5].

Q2: What are the common side effects of carvedilol phosphate? Common side effects include bradycardia, hypotension, heart failure/fluid retention, and non-allergic bronchospasm[2][5].

Q3: Which region is expected to dominate the carvedilol phosphate market? North America is expected to dominate the market due to high awareness about cardiac problems and efficient healthcare infrastructure[4].

Q4: What are the key drivers of the carvedilol phosphate market? Key drivers include the increasing prevalence of cardiovascular diseases, growing geriatric population, poor lifestyle factors, and advancements in medical R&D and technologies[1][4].

Q5: How is the Asia Pacific region contributing to the carvedilol phosphate market? The Asia Pacific region is anticipated to grow rapidly due to the rising prevalence of hypertension in low and middle-income countries and the establishment of R&D centers by pharmaceutical companies[1][4].

Cited Sources:

1. Research Nester: Carvedilol Drug Market Size, Growth Forecasts 2036
2. FDA: COREG CR® (carvedilol phosphate) Extended-release Capsules
3. PubChem: Carvedilol Phosphate
4. BioSpace: Carvedilol Drug Market Analysis, Status and Business Outlook from 2021 to 2031
5. DailyMed: CARVEDILOL PHOSPHATE capsule, extended release