CARVEDILOL PHOSPHATE - Generic Drug Details

What are the generic drug sources for carvedilol phosphate and what is the scope of patent protection?

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. Nine 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:	9
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	5
Patent Applications:	94
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
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-004	Oct 20, 2006	AB	RX	Yes	No	8,101,209*PED				Y
Impax Labs Inc	CARVEDILOL PHOSPHATE	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	204717-003	May 7, 2018	AB	RX	No	No
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	090132-004	Oct 25, 2017	AB	RX	No	No
Sun Pharm Industries	CARVEDILOL PHOSPHATE	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	090132-003	Oct 25, 2017	AB	RX	No	Yes
Sun Pharm Industries	CARVEDILOL PHOSPHATE	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	090132-001	Oct 25, 2017	AB	RX	No	No
Sun Pharm Industries	CARVEDILOL PHOSPHATE	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	090132-002	Oct 25, 2017	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	4,503,067*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	022012-002	Oct 20, 2006	4,503,067*PED
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-004	Oct 20, 2006	5,902,821*PED
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-003	Oct 20, 2006	5,902,821*PED
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-002	Oct 20, 2006	RE40000*PED
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-001	Oct 20, 2006	4,503,067*PED

International Patents for CARVEDILOL PHOSPHATE

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1072898	Galenic microparticulate oral formulation for delayed and controlled release of pharmaceutical active principles
Israel	160795	GALENIC MICROPARTICULATE ORAL FORMULATION FOR DELAYED AND CONTROLLED RELEASE OF PHARMACEUTICAL ACTIVE PRINCIPLES
European Patent Office	1744729	FORME GALENIQUE ORALE MICROPARTICULAIRE POUR LA LIBERATION PROLONGEE ET CONTROLEE DE PRINCIPES ACTIFS PHARMACEUTIQUES (MICROPARTICULATE ORAL GALENICAL FORM FOR THE DELAYED AND CONTROLLED RELEASE OF PHARMACEUTICAL ACTIVE PRINCIPLES)
Japan	2007532689
Brazil	PI0213175	forma galênica oral macroparticulada para a liberação retardada e controlada de um princípios ativos farmacêuticos e uso de microcápsulas "reservatório"
Japan	2005506336
China	100341493

Market Dynamics and Financial Trajectory for Carvedilol Phosphate

Last updated: July 27, 2025

Introduction

Carvedilol phosphate, a beta-blocker with vasodilatory properties, has established itself as a vital therapeutic agent in managing hypertension, congestive heart failure (CHF), and left ventricular hypertrophy. Its multifaceted mechanism, combining beta-adrenergic blockade with alpha-1 antagonism, underscores its clinical utility. As the pharmaceutical landscape evolves, analyzing market dynamics and the financial trajectory for carvedilol phosphate unveils growth opportunities, competitive influences, and evolving treatment paradigms.

Market Landscape and Therapeutic Segment

The global cardiovascular therapeutics segment, characterized by high prevalence rates of hypertension and CHF, fundamentally propels carvedilol phosphate’s market. The drug benefits from widespread adoption in developed regions and increasing penetration in emerging markets. In 2022, hypertension affected approximately 1.28 billion adults worldwide, with a substantial share receiving beta-blockers like carvedilol as part of key treatment regimens [1].

Carvedilol phosphate’s unique formulation as a sustained-release or novel patented version amplifies its market position, especially when integrated with VIP (Vasoactive Intestinal Peptide) targeting therapies or in combination products. Its role in reducing mortality, improving exercise tolerance, and mitigating disease progression sustains demand.

Market Drivers

1. Rising Cardiovascular Disease Incidence
   The increasing prevalence of hypertension and heart failure globally fuels demand. Aging populations, sedentary lifestyles, and rising obesity rates contribute significantly to this trend, particularly in Asia-Pacific and Latin America [2].

2. Expanding Indication Portfolio
   Recent research suggests potential benefits of carvedilol phosphate in treating other conditions, such as diabetic cardiomyopathy and post-myocardial infarction remodeling, expanding its clinical application scope.

3. Patent Expiry and Formulation Innovations
   While some carvedilol formulations face patent expirations, new delivery platforms—liposomal, nanoparticle-based, or fixed-dose combinations—offer opportunities for sustained growth and premium pricing.

4. Growing Adoption in Developing Markets
   As healthcare infrastructure improves and awareness increases, emerging economies present lucrative markets. Governments’ focus on cardiovascular disease management enhances pharmacovigilance and prescription rates.

Market Challenges

1. Generic Competition
   Post patent expiry, generic carvedilol products flood markets, exerting downward pressure on prices and profit margins. The commoditization of beta-blockers challenges branded formulations' market share.

2. Regulatory and Safety Concerns
   Adverse effects such as bradycardia, hypotension, and bronchospasm require vigilant monitoring. Regulatory agencies’ strict approval processes can delay new formulations or indication extensions.

3. Competition from Alternative Therapies
   ACE inhibitors, ARBs, and newer agents like sacubitril/valsartan compete with carvedilol in heart failure management, influencing prescribing behaviors.

4. Technological and Pricing Pressures
   Healthcare systems’ emphasis on cost-effectiveness incentivizes formulary favorability toward cheaper generic options, gradually squeezing manufacturer margins.

Financial Trajectory and Revenue Projections

Analyzing revenue streams indicates carvedilol phosphate’s steady contribution to pharmaceutical portfolios, especially where it maintains a strong brand presence. While the global beta-blockers market was valued at approximately USD 3.2 billion in 2021, driven by carvedilol’s share, projections suggest a compound annual growth rate (CAGR) of approximately 2-4% over the next five years [3].

Future Growth Opportunities

• Novel Formulation and Delivery: Innovating with controlled-release, transdermal patches, or combination therapies can differentiate products and command premium pricing.

• Expanded Indication Approval: Gaining regulatory approval for additional conditions can open new revenue streams.

• Strategic M&A and Licensing: Partnerships with biotech firms or licensing agreements can accelerate access to emerging markets and technologies.

• Digital and Precision Medicine: Integration of pharmacogenomics for tailored therapy enhances efficacy and safety, encouraging premium pricing.

Impact of Regulatory and Patent Landscape

Patent expirations typically occur 10-12 years after initial filing, with many carvedilol formulations facing generic competition as early as 2014-2018. Manufacturers investing in patent prolongation through formulation patents or combination products can sustain revenue. For instance, a recent patent filing for a controlled-release carvedilol formulation extends exclusivity margins, impacting the financial trajectory favorably.

Market Entry and Competitive Strategies

Emerging players entering the carvedilol phosphate space often focus on voicing improved safety profiles, patient adherence, and cost-effectiveness. Differentiation strategies include developing innovative delivery systems, expanding indication labels, and targeting underrepresented patient subgroups.

Key Market Players and Their Strategies

Major pharmaceutical entities like GlaxoSmithKline, Pfizer, and Teva have historically dominated carvedilol markets. Their ongoing investments in R&D, strategic acquisitions, and geographical expansion shape pricing and market penetration strategies [4].

Economic Impact and Pricing Trends

Pricing for branded carvedilol phosphate remains relatively higher compared to generics, especially when tied to specific formulations or indications. Post-generic entry, prices tend to decline sharply, reducing revenue unless manufacturers innovate or secure new patents.

Market Outlook and Forecast

While near-term prospects are constrained by generic competition, long-term growth hinges on innovation, new indications, and market expansion. The evolving landscape suggests a moderate growth trajectory with CAGR projections of 2-3% through 2030, driven by healthcare infrastructure improvements and technological advancements.

Conclusion

Carvedilol phosphate’s market dynamics are characterized by a balance of clinical demand, patent challenges, technological innovation, and competitive pressures. Strategic focus on formulation innovation, indication expansion, and geographical diversification will be critical for stakeholders seeking to enhance financial trajectories in this mature yet evolving segment.

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Key Takeaways

• Global hypertension and CHF prevalence sustain steady demand for carvedilol phosphate, bolstering its market relevance.
• Patent expirations and generic competition pressure profit margins, prompting innovation-driven differentiation.
• Expanding indications and combination therapies present significant growth avenues.
• Emerging markets offer considerable opportunities, contingent upon effective regulatory and pricing strategies.
• Continuous technological innovation and strategic collaborations are vital to maintaining competitive advantage and ensuring positive financial trajectories.

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FAQs

1. What factors influence the market growth of carvedilol phosphate?
Market growth is primarily driven by rising cardiovascular disease prevalence, expanding indications, technological innovations, and increasing adoption in emerging economies. Conversely, patent expirations and intense generic competition constrain revenue growth.

2. How does patent expirability impact carvedilol phosphate’s financial prospects?
Patent expiry generally leads to generic entry, resulting in significant price reductions and revenue declines for brand-name formulations. Manufacturers mitigate this through formulation patents, combination therapies, and expanding indications.

3. What are the main challenges facing carvedilol phosphate market expansion?
Key challenges include rising generic competition, safety concerns, competitive therapies, and healthcare cost containment pressures which favor lower-cost alternatives.

4. Which regions present the most promising opportunities for carvedilol phosphate?
Emerging markets in Asia-Pacific, Latin America, and Africa exhibit high growth potential due to increasing cardiovascular disease rates and improving healthcare infrastructure.

5. What innovations are shaping the future of carvedilol phosphate?
Innovations include controlled-release formulations, transdermal patches, fixed-dose combinations, and utilization of pharmacogenomic data for personalized therapy, all aimed at enhancing efficacy and adherence.

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References

[1] World Health Organization. Hypertension Data. 2022.
[2] Global Heart Failure Market Analysis, 2022. MarketResearch.com.
[3] Grand View Research. Beta-Blockers Market Size & Trends. 2022.
[4] IQVIA. Pharmaceutical Market Reports, 2022.