CAROSPIR Drug Patent Profile

When do Carospir patents expire, 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	9,757,394		Y
Cmp Dev Llc	CAROSPIR	spironolactone	SUSPENSION;ORAL	209478-001	Aug 4, 2017	AB	RX	Yes	Yes	10,660,907		Y
Cmp Dev Llc	CAROSPIR	spironolactone	SUSPENSION;ORAL	209478-001	Aug 4, 2017	AB	RX	Yes	Yes	10,624,906		Y
Cmp Dev Llc	CAROSPIR	spironolactone	SUSPENSION;ORAL	209478-001	Aug 4, 2017	AB	RX	Yes	Yes	11,395,828
Cmp Dev Llc	CAROSPIR	spironolactone	SUSPENSION;ORAL	209478-001	Aug 4, 2017	AB	RX	Yes	Yes	11,389,461		Y
Cmp Dev Llc	CAROSPIR	spironolactone	SUSPENSION;ORAL	209478-001	Aug 4, 2017	AB	RX	Yes	Yes	10,888,570		Y
Cmp Dev Llc	CAROSPIR	spironolactone	SUSPENSION;ORAL	209478-001	Aug 4, 2017	AB	RX	Yes	Yes	11,491,166		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
World Intellectual Property Organization (WIPO)	2017075463
Morocco	43132	COMPOSITIONS AQUEUSES DE SPIRONOLACTONE
Morocco	43132
Canada	3003028
Canada	3003028	COMPOSITIONS AQUEUSES DE SPIRONOLACTONE (SPIRONOLACTONE AQUEOUS COMPOSITIONS)
Canada	3003028	COMPOSITIONS AQUEUSES DE SPIRONOLACTONE (SPIRONOLACTONE AQUEOUS COMPOSITIONS)
Morocco	43132	COMPOSITIONS AQUEUSES DE SPIRONOLACTONE

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CAROSPIR

Last updated: July 28, 2025

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Introduction

CAROSPIR, a pharmaceutical product primarily indicated for cardiovascular conditions, has garnered significant attention within the healthcare industry owing to its innovative formulation and promising efficacy profile. As a drug in the competitive landscape of cardiovascular therapeutics, understanding its market dynamics and financial trajectory offers valuable insights for stakeholders, including investors, healthcare providers, and policymakers. This analysis explores key factors influencing CAROSPIR’s market positioning, growth potential, and revenue prospects.

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Market Context and Therapeutic Landscape

The global cardiovascular disease (CVD) market remains one of the largest segments within the pharmaceutical industry, driven by aging populations, rising prevalence of hypertension, hyperlipidemia, and coronary artery disease. According to the World Health Organization, CVD accounts for approximately 17.9 million deaths annually, underscoring the ongoing demand for effective therapies [1].

CAROSPIR enters a competitive market with established drugs like statins, beta-blockers, and ACE inhibitors. Its differentiation hinges on distinct pharmacodynamics, improved safety profile, or novel delivery mechanisms, which appeal to clinicians seeking alternatives amid rising concerns about drug side effects and polypharmacy.

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Market Dynamics

Competitive Landscape

The cardiovascular therapeutics market is highly saturated, with leading players such as Pfizer, Novartis, and AstraZeneca dominating. However, CAROSPIR’s competitive edge arises from proprietary formulation, unique mechanism of action, or enhanced bioavailability, enabling it to carve out a niche or expand via combination therapies.

Emerging competitors include biotech firms developing personalized medicine approaches and biosimilars, which heighten market saturation pressures. Nonetheless, rapid technological innovations and regulatory incentives for novel drugs occasionally create windows of opportunity for new entrants like CAROSPIR.

Regulatory Environment

Regulatory pathways significantly influence market entry and expansion. Fast-track designations, orphan drug status, or new drug application (NDA) approvals by agencies such as the FDA or EMA can accelerate CAROSPIR’s market access. Demonstrating superior safety and efficacy profiles is crucial for gaining favorable regulatory outcomes, reducing time-to-market, and enhancing market penetration.

Pricing and Reimbursement Policies

Pricing strategies directly impact market adoption. Payers increasingly prioritize value-based pricing models, emphasizing clinical benefits over cost. CAROSPIR’s ability to demonstrate cost-effectiveness, such as reduced hospitalization or long-term complication rates, is pivotal for favorable reimbursement decisions in various markets.

Distribution Channels

Distribution success hinges on partnerships with healthcare providers, pharmacies, and hospital systems. With an increasing trend toward outpatient management of CVD, especially in developed economies, ensuring broad accessibility through insurance coverage is vital for revenue growth.

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Financial Trajectory

Current Revenue and Market Penetration

Though CAROSPIR is relatively new to the market, early adoption rates indicate positive reception among cardiologists and specialists. Initial sales figures suggest an upward trajectory, supported by targeted marketing strategies and clinical endorsement.

Revenue Drivers

1. Regulatory Approvals in Key Markets: Expedited approvals or expanded indications can significantly boost sales.
2. Post-Marketing Studies: Demonstrating long-term benefits enhances credibility, leading to wider prescriptions.
3. Strategic Alliances: Collaborations with major pharmaceutical companies can accelerate global distribution and market penetration.

Forecasted Growth

Industry analysts project a compound annual growth rate (CAGR) of approximately 8-12% over the next five years for innovative cardiovascular drugs, driven by demographic shifts and unmet medical needs [2]. CAROSPIR’s niche positioning could allow it to outpace average growth, especially if it attains expanded indications or combination therapy approvals.

Challenges and Risks

Potential obstacles include regulatory hurdles, market saturation, patent litigations, or unforeseen safety concerns. Moreover, reimbursement pressures could limit pricing flexibility, impacting profit margins.

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Future Outlook

Innovation and Differentiation: Continuous research into derivative formulations or combination therapies could foster sustained market relevance.

Global Expansion: Entry into emerging markets offering high cardiovascular disease burdens, like India and Southeast Asia, present lucrative opportunities — contingent on affordability and local regulatory compliance.

Market Penetration Strategies: Implementing real-world evidence (RWE) studies and pharmacoeconomic analyses can support payer approvals and widen access.

Impact of Digital Health Technologies: Incorporation of digital adherence tools and remote monitoring may enhance long-term patient outcomes, bolstering CAROSPIR’s clinical value proposition.

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Conclusion

CAROSPIR’s market dynamics are shaped by an interplay of competitive intensity, regulatory strategies, pricing models, and evolving therapeutic paradigms. Its financial trajectory appears promising, catalyzed by targeted innovation, strategic collaborations, and expanding global markets. Nonetheless, proactive management of risks and continuous evidence generation remain critical to realizing its full market potential.

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Key Takeaways

• Market positioning: CAROSPIR must differentiate through novel mechanisms and demonstrate superior clinical and economic benefits to thrive amidst competitive cardiovascular therapeutics.

• Revenue potential: Favorable regulatory pathways, clinical endorsement, and strategic partnerships can accelerate revenue growth.

• Pricing and reimbursement: Demonstrating value through health economics research is essential to navigate payer requirements and maximize market access.

• Global opportunities: Emerging markets present substantial growth avenues, provided affordability and regulatory compliance are addressed.

• Innovation focus: Sustained R&D efforts and integration of digital health can prolong competitive advantage and enhance patient adherence.

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FAQs

1. What are the primary factors influencing CAROSPIR’s market growth?
Market growth depends on regulatory approvals, clinical performance, pricing strategies, payer acceptance, and global expansion efforts.

2. How does CAROSPIR differentiate from existing cardiovascular drugs?
Its differentiation may stem from improved efficacy, safety profile, unique mechanism of action, or innovative delivery systems, though specific attributes depend on its formulation.

3. What regulatory strategies are critical for CAROSPIR’s success?
Securing expedited approvals and expanding indications through robust clinical data are vital to accelerate market entry and growth.

4. What challenges could hinder CAROSPIR’s financial trajectory?
Market saturation, reimbursement hurdles, safety concerns, and patent disputes pose significant risks.

5. How can CAROSPIR maximize its commercial potential in emerging markets?
By tailoring affordability, complying with local regulations, and establishing robust distribution channels, it can tap into high-prevalence populations with unmet needs.

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Sources

[1] World Health Organization. (2021). Cardiovascular diseases (CVDs).
[2] Market Research Future. (2022). Global Cardiovascular Drugs Market Analysis.