CAROSPIR Drug Patent Profile

Which patents cover Carospir, and when can generic versions of Carospir launch?

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-three 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:	87
Clinical Trials:	1
Patent Applications:	4,006
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

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/000105 For 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/005535 In 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
Morocco	43132
Morocco	43132	COMPOSITIONS AQUEUSES DE SPIRONOLACTONE
World Intellectual Property Organization (WIPO)	2017075463

CAROSPIR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CAROSPIR

Introduction

CAROSPIR, an FDA-approved oral suspension of spironolactone, has entered the market with a unique value proposition, addressing the needs of adult patients with specific medical conditions and swallowing difficulties. Here, we delve into the market dynamics and financial trajectory of CAROSPIR.

Market Need and Target Population

CAROSPIR is designed for patients who have difficulty swallowing tablets or capsules, a condition known as dysphagia. This includes patients with heart failure, hypertension, and edema associated with cirrhosis. The drug's liquid formulation eliminates the need for crushing or compounding, which can be inconsistent and hazardous[1][2][4].

Competitive Landscape

The market for spironolactone is dominated by traditional tablet forms, such as Aldactone. However, CAROSPIR stands out as the first and only FDA-approved oral suspension of spironolactone. This differentiation is crucial, especially given the inconsistencies and safety concerns associated with crushed or compounded spironolactone preparations[2].

Regulatory Approval and Compliance

CAROSPIR has received FDA approval, which is a significant milestone. The drug is manufactured in GMP-compliant facilities, ensuring consistency and potency in dosing. This regulatory backing enhances its credibility and market acceptance[1][2][4].

Indications and Usage

CAROSPIR is indicated for several critical conditions:

• Treatment of NYHA Class III-IV heart failure and reduced ejection fraction
• Add-on therapy for hypertension
• Management of edema in adult cirrhotic patients These indications position CAROSPIR as a versatile treatment option within the cardiovascular and hepatology markets[1][2][4].

Dosage and Administration

The dosing regimen for CAROSPIR is straightforward and varies based on the condition being treated. For heart failure, the initial dose is 20 mg once daily. For hypertension, it ranges from 20 to 75 mg daily, and for edema associated with cirrhosis, the initial dose is 75 mg in a hospital setting. This clarity in dosing helps in patient compliance and reduces the risk of adverse reactions[2][4].

Safety and Efficacy

CAROSPIR has been tested to ensure potency and consistency in dosing, unlike compounded preparations which can exhibit wide variations in potency. The most common adverse reaction is gynecomastia in men, but overall, CAROSPIR has shown a favorable safety profile. It is contraindicated in patients with hyperkalemia, Addison’s disease, and those using eplerenone[1][2][4].

Market Penetration and Adoption

Given its unique formulation and FDA approval, CAROSPIR is likely to gain significant market penetration. Healthcare providers are more likely to prescribe an FDA-approved liquid suspension over compounded alternatives due to the consistency and safety it offers. This could lead to a steady increase in prescriptions and market share over time.

Financial Trajectory

Pricing Strategy

CAROSPIR's pricing strategy is critical to its financial success. While the exact pricing is not detailed in the sources, it is likely to be competitive with other spironolactone products on the market. The drug's unique benefits, such as consistency and ease of administration, may justify a premium pricing strategy.

Revenue Projections

With its broad indications and the growing need for safe and consistent spironolactone formulations, CAROSPIR is poised for significant revenue growth. As more healthcare providers become aware of its benefits, prescriptions are likely to increase, driving revenue upwards.

Cost Savings

For patients and payers, CAROSPIR could offer cost savings by reducing the need for hospitalizations due to heart failure and managing edema more effectively. This long-term cost savings can make CAROSPIR a more attractive option despite any potential higher upfront costs.

Market Trends

The pharmaceutical market is subject to various trends, including increasing prices for drugs post-launch. However, CAROSPIR's unique position as an FDA-approved oral suspension may shield it from some of these price pressures, especially if it demonstrates clear clinical and economic benefits[3].

Patient Access and Affordability

To enhance patient access, CMP Pharma offers a co-pay program that can reduce the out-of-pocket costs for patients. This program is subject to terms and conditions but can make CAROSPIR more affordable for those who need it[2].

Conclusion

CAROSPIR has entered the market with a strong value proposition, addressing critical needs in patient care. Its FDA approval, consistent potency, and ease of administration make it a compelling option for healthcare providers and patients alike. As the market continues to evolve, CAROSPIR is well-positioned for significant market penetration and revenue growth.

Key Takeaways

• Unique Formulation: CAROSPIR is the first and only FDA-approved oral suspension of spironolactone.
• Consistent Potency: Ensures consistent dosing, unlike compounded preparations.
• Broad Indications: Used for heart failure, hypertension, and edema associated with cirrhosis.
• Safety Profile: Favorable safety profile with common adverse reactions managed effectively.
• Market Penetration: Likely to gain significant market share due to its unique benefits.
• Financial Trajectory: Poised for revenue growth driven by increasing prescriptions and cost savings.

FAQs

What is CAROSPIR used for?

CAROSPIR is used for the treatment of NYHA Class III-IV heart failure, as an add-on therapy for hypertension, and for the management of edema in adult cirrhotic patients[1][2][4].

Why is CAROSPIR preferred over compounded spironolactone?

CAROSPIR is preferred due to its consistent potency and safety profile, which is not guaranteed with compounded preparations[1][2].

What are the common adverse reactions associated with CAROSPIR?

The most common adverse reaction is gynecomastia in men. Other potential side effects include hyperkalemia, hypotension, and worsening renal function[1][2][4].

Is CAROSPIR therapeutically equivalent to Aldactone tablets?

No, CAROSPIR is not therapeutically equivalent to Aldactone tablets and has shown 15 to 37% higher bioavailability[2].

Are there any contraindications for CAROSPIR?

Yes, CAROSPIR is contraindicated in patients with hyperkalemia, Addison’s disease, and those using eplerenone[1][2][4].

Sources

1. CaroSpir® Spironolactone - CaroSpir.com
2. CaroSpir Digital Sell Sheet - CaroSpir.com
3. Steady Increase In Prices For Oral Anticancer Drugs After ... - PubMed
4. CAROSPIR suspension - DailyMed