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Last Updated: October 14, 2024

CAROSPIR Drug Patent Profile


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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 23rd, 1986.

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Drug patent expirations by year for CAROSPIR
Drug Prices for CAROSPIR

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Recent Clinical Trials for CAROSPIR

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

SponsorPhase
Mayo ClinicPhase 2

See all CAROSPIR clinical trials

Pharmacology for CAROSPIR
Drug ClassAldosterone Antagonist
Mechanism of ActionAldosterone 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.

Patents protecting CAROSPIR

Spironolactone aqueous compositions
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Spironolactone aqueous compositions
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Spironolactone aqueous compositions
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Spironolactone aqueous compositions
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Spironolactone aqueous compositions
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Spironolactone aqueous compositions
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Patented Use: CAROSPIR IS INDICATED FOR TREATMENT OF NYHA CLASS III-IV HEART FAILURE AND REDUCED EJECTION FRACTION TO INCREASE SURVIVAL, MANAGE EDEMA, AND TO REDUCE THE NEED FOR HOSPITALIZATION FOR HEART FAILURE

Spironolactone aqueous compositions
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Patented Use: CAROSPIR IS INDICATED AS AN ADD-ON THERAPY FOR THE TREATMENT OF HYPERTENSION, TO LOWER BLOOD PRESSURE IN ADULT PATIENTS WHO ARE NOT ADEQUATELY CONTROLLED ON OTHER AGENTS

Spironolactone aqueous compositions
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Patented Use: CAROSPIR IS INDICATED FOR THE MANAGEMENT OF EDEMA IN ADULT CIRRHOTIC PATIENTS WHEN EDEMA IS NOT RESPONSIVE TO FLUID AND SODIUM RESTRICTION


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Spironolactone aqueous formulations
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Patented Use: CAROSPIR IS INDICATED FOR TREATMENT OF NYHA CLASS III-IV HEART FAILURE AND REDUCED EJECTION FRACTION TO INCREASE SURVIVAL, MANAGE EDEMA, AND TO REDUCE THE NEED FOR HOSPITALIZATION FOR HEART FAILURE

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

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for CAROSPIR

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

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

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