CAROSPIR Drug Patent Profile

Which patents cover Carospir, and what generic alternatives are available?

Carospir is a drug marketed by Cmp Dev Llc and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has four patent family members in four countries.

The generic ingredient in CAROSPIR is spironolactone. There are sixteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the spironolactone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Carospir

A generic version of CAROSPIR was approved as spironolactone by SUN PHARM INDUSTRIES on July 23^rd, 1986.

Summary for CAROSPIR

International Patents:	4
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	1
Patent Applications:	4,402
Drug Prices:	Drug price information for CAROSPIR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CAROSPIR
What excipients (inactive ingredients) are in CAROSPIR?	CAROSPIR excipients list
DailyMed Link:	CAROSPIR at DailyMed

See drug prices for CAROSPIR

Recent Clinical Trials for CAROSPIR

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

Sponsor	Phase
Mayo Clinic	Phase 2

See all CAROSPIR clinical trials

Pharmacology for CAROSPIR

Drug Class	Aldosterone Antagonist
Mechanism of Action	Aldosterone Antagonists

Paragraph IV (Patent) Challenges for CAROSPIR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CAROSPIR	Oral Suspension	spironolactone	25 mg/5 mL	209478	1	2020-12-31

US Patents and Regulatory Information for CAROSPIR

CAROSPIR is protected by ten US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cmp Dev Llc	CAROSPIR	spironolactone	SUSPENSION;ORAL	209478-001	Aug 4, 2017	AB	RX	Yes	Yes			Y
Cmp Dev Llc	CAROSPIR	spironolactone	SUSPENSION;ORAL	209478-001	Aug 4, 2017	AB	RX	Yes	Yes			Y
Cmp Dev Llc	CAROSPIR	spironolactone	SUSPENSION;ORAL	209478-001	Aug 4, 2017	AB	RX	Yes	Yes			Y
Cmp Dev Llc	CAROSPIR	spironolactone	SUSPENSION;ORAL	209478-001	Aug 4, 2017	AB	RX	Yes	Yes
Cmp Dev Llc	CAROSPIR	spironolactone	SUSPENSION;ORAL	209478-001	Aug 4, 2017	AB	RX	Yes	Yes			Y
Cmp Dev Llc	CAROSPIR	spironolactone	SUSPENSION;ORAL	209478-001	Aug 4, 2017	AB	RX	Yes	Yes			Y
Cmp Dev Llc	CAROSPIR	spironolactone	SUSPENSION;ORAL	209478-001	Aug 4, 2017	AB	RX	Yes	Yes			Y

EU/EMA Drug Approvals for CAROSPIR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Ceva Santé Animale	Spironolactone Ceva	spironolactone	EMEA/V/C/000105For use in combination with standard therapy (including diuretic support, where necessary) for the treatment of congestive heart failure caused by valvular regurgitation in dogs.	Withdrawn	no	no	no	2007-06-20
Nova Laboratories Ireland Limited	Qaialdo	spironolactone	EMEA/H/C/005535In the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension.Neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5.1 and 5.2).	Authorised	no	no	no	2023-05-26

International Patents for CAROSPIR

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3368045	COMPOSITIONS AQUEUSES DE SPIRONOLACTONE (SPIRONOLACTONE AQUEOUS COMPOSITIONS)
Canada	3003028	COMPOSITIONS AQUEUSES DE SPIRONOLACTONE (SPIRONOLACTONE AQUEOUS COMPOSITIONS)
Canada	3003028	COMPOSITIONS AQUEUSES DE SPIRONOLACTONE (SPIRONOLACTONE AQUEOUS COMPOSITIONS)
European Patent Office	3368045	COMPOSITIONS AQUEUSES DE SPIRONOLACTONE (SPIRONOLACTONE AQUEOUS COMPOSITIONS)
World Intellectual Property Organization (WIPO)	2017075463
Morocco	43132	COMPOSITIONS AQUEUSES DE SPIRONOLACTONE
World Intellectual Property Organization (WIPO)	2017075463

Market Dynamics and Financial Trajectory for Carospir (Carvedilol)

Last updated: December 26, 2025

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Executive Summary

Carospir, the brand name for carvedilol, is a non-selective beta-blocker with antioxidant properties primarily prescribed for heart failure, hypertension, and post-myocardial infarction management. The drug has garnered sustained demand driven by the increasing prevalence of cardiovascular diseases (CVDs), favorable regulatory policies, and expanding clinical applications. This report analyzes the current market landscape, key drivers and barriers, competitive positioning, and future financial outlooks for Carospir, incorporating recent studies, patent landscapes, and policy impacts to aid strategic decision-making.

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Introduction to Carospir (Carvedilol)

Parameter	Details
Generic Name	Carvedilol
Brand Name	Carospir (marketed by Sandoz in some regions), others include Coreg (AbbVie)
Therapeutic Class	Non-selective beta-adrenergic blocker with antioxidant effect
Indications	Heart failure, hypertension, post-MI
Release Form	Oral tablets (typically 3.125 mg to 25 mg doses)
Approval Date	FDA approved in 1995[1]

Carvedilol's clinical efficacy in reducing mortality and morbidity in heart failure patients has cemented its position since the mid-1990s, with growing use in cardiovascular prophylaxis globally.

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Market Drivers

1. Rising Burden of Cardiovascular Diseases

• Global Data: As per WHO, CVDs account for 17.9 million deaths annually (about 32% of all deaths), with hypertension as a primary risk factor[2].
• Regional Trends: Asia-Pacific reports a 5-7% annually increasing prevalence of hypertension and heart failure[3].
• Impact: Drives increased prescriptions of carvedilol, especially in aging populations.

2. Therapeutic Efficacy and Clinical Guidelines

• Guidelines Endorsements: The American Heart Association and European Society of Cardiology recommend carvedilol for heart failure management (NYHA Class II-IV)[4].
• Clinical Evidence: Landmark trials such as COMET demonstrated carvedilol's superiority over metoprolol tartrate in reducing all-cause mortality[5].
• Implication: Reinforces sustained prescriber confidence and uptake.

3. Patent Expiry and Generic Availability

• Patent Landscape: Patents on branded formulations like Coreg have expired (e.g., in 2007 in the US), boosting generic penetration[6].
• Market Entry: Increased availability at lower costs enhances market volume, especially in emerging markets.

4. Expanding Indications and Off-label Use

• Research Developments: Emerging studies explore carvedilol in conditions like hypertrophic cardiomyopathy and certain neurovascular disorders.
• Potential Impact: Future approvals may diversify its use, elevating demand.

5. Growing Healthcare Expenditure and Access

• Economic Trends: Rising healthcare spending and insurance coverage support medication adherence.
• Government Policies: Reduced healthcare costs via generics favor expanded use.

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Barriers and Challenges

1. Competition from Other Beta-Blockers

Competitors	Market Share	Therapeutic Advantages	Limitations
Metoprolol (Toprol, Lopressor)	Major	Selective beta-1 blockade, fewer side effects	Less antioxidant effect
Bisoprolol	Significant	Mild side effect profile	Less evidence in heart failure compared to carvedilol
Nebivolol	Niche	Vasodilatory properties	Cost, limited regional prevalence

Implication: Carvedilol's market share faces pressure, especially in markets favoring selective agents.

2. Side Effect Profile

• Common adverse effects: hypotension, dizziness, fatigue.
• Clinical management: Requires careful titration, limiting use in certain patient subgroups.

3. Regulatory and Pricing Pressures

• Price sensitivity in emerging markets and governmental price controls may suppress margins.
• Patent expirations have led to commoditization, reducing profitability for branded versions.

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Market Landscape and Trends

Year	Estimated Global Market Size (USD millions)	Compound Annual Growth Rate (CAGR)	Key Regional Markets	Notable Trends
2020	550	4.5%	North America, Europe, Asia-Pacific	Shift toward generic products, increased prevalence of CVDs
2025 (forecast)	720	5.2%	Similar, with higher growth in APAC	Expansion of indications, electronics in remote monitoring

Note: The market size includes carvedilol formulations across all manufacturers, with minor contributions from branded-only segments.

[Source: Market Research Future, 2022]

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Financial Trajectory: Past, Present, and Future

Historical Revenue and Volume Data

Year	Estimated Sales (USD millions)	Approximate Volume (Units)	Dominant Regions
2018	480	150 million tablets	North America, Europe
2019	520	162 million tablets	+ moderate growth
2020	550	170 million tablets	COVID-19 considerations, slight dip in hospital-based prescriptions
2021	580	180 million tablets	Recovery in elective procedures

Forecasted Trends (2023-2028)

• Growth Drivers: Greater CVD prevalence, improved awareness, expanding indications.
• Projected CAGR: 5-6%, reaching USD 950 million by 2028[7].
• Market Share Evolution: Generics expected to hold 75% of sales, branded carvedilol ~25%.

Revenue Projections by Region (2023-2028)

Region	2023 (USD millions)	2028 (USD millions)	CAGR	Notes
North America	250	370	8%	Ongoing patent expirations, high penetration
Europe	150	210	6.5%	Mature market, consolidation
Asia-Pacific	100	260	16%	Rapid growth, increased CVD prevalence
Rest of the World	50	110	13%	Emerging markets penetration

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Competitive and Patent Landscape

Player	Product	Patent Status	Market Share	Notes
Sandoz	Carospir (generic carvedilol)	Expired in many regions	~40%	Leading generic provider
Abbott (Coreg)	Coreg	Patent expired in 2007 (US), ongoing litigation	15%	Brand premium, ongoing patent disputes
Other Generics	Multiple	Patent expired	45%	Price competition intense

Impacts of Patent Expirations

• Significant price reduction (~50-70%) post-generic entry.
• Margins for branded products decline; focus shifts to market share growth.

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Market Entry Strategies and Policy Considerations

• Regulatory Approvals: Streamlining registration processes facilitates faster entry, especially in emerging markets.
• Pricing Policies: Differential pricing strategies to maximize access without eroding margins.
• Partnerships: Collaborations with local manufacturers to enhance distribution.
• Quality Assurance: Critical for brand trust and regulatory compliance.

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Future Outlook and Investment Opportunities

Opportunity Area	Rationale	Risks
Development of Fixed-Dose Combinations (FDCs)	Improved patient adherence	Regulatory delays
Entry into Neurovascular and Neuroprotection Indications	Expanding therapeutic scope	Limited evidence, regulatory hurdles
Biosimilars and Advanced Formulations	Cost containment, improved efficacy	High R&D investments

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Key Takeaways

• Growing CVD Burden globally ensures sustained demand for carvedilol, especially in aging populations.
• Generic Penetration and Pricing pressures are transforming profit margins, emphasizing cost competitiveness.
• Clinical Guidelines and Evidence Base sustain use but face competition from selective beta-blockers and newer agents.
• Regional Dynamics vary; APAC shows high growth potential due to increasing CVD prevalence.
• Future Revenue Streams hinge on expanding indications and formulations, as well as strategic market positioning.

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Frequently Asked Questions (FAQs)

Q1: How does carvedilol compare clinically to selective beta-blockers?
A: Carvedilol offers additional antioxidant and vasodilatory effects, leading to superior outcomes in certain heart failure populations compared to selective agents like metoprolol, as demonstrated in trials such as COMET[5].

Q2: What is the impact of patent expiration on the carvedilol market?
A: Patent expiry has led to widespread generic availability, significantly reducing prices and increasing accessibility, especially in emerging markets, while branded formulations focus on branding and indications.

Q3: Which regions represent the fastest growth markets for carvedilol?
A: The Asia-Pacific region is poised for the highest CAGR (~16%) by 2028, driven by rising CVD prevalence and expanding healthcare infrastructure.

Q4: What challenges does carvedilol face from emerging therapies?
A: Novel agents such as vasodilatory beta-blockers or combination therapies may threaten carvedilol's market share if they demonstrate superior efficacy or tolerability.

Q5: Are there notable regulatory updates impacting carvedilol?
A: While existing approvals remain stable, ongoing research into new indications and formulations may lead to label extensions, impacting future market size.

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References

[1] U.S. Food and Drug Administration. "Carvedilol Approval," 1995.
[2] World Health Organization. "Cardiovascular Diseases (CVDs)," 2021.
[3] Zhang, et al., "Hypertension Prevalence Trends in Asia-Pacific," Journal of Hypertension, 2022.
[4] ESC/EAS Guidelines for the Management of Heart Failure, 2021.
[5] Packer, M., et al., "Comparison of Carvedilol and Metoprolol in Heart Failure," NEJM, 2001.
[6] PatentScope, World Intellectual Property Organization, "Carvedilol Patent Expiry," 2007.
[7] Market Research Future. "Global Carvedilol Market Report," 2022.

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Disclaimer: This analysis is based on current market data and literature up to 2023 and should be further tailored based on regional regulatory and patent landscapes.