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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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: | 3,945 |
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 |
Recent Clinical Trials for CAROSPIR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Mayo Clinic | Phase 2 |
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.
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 | |||
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 | ||
>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 |
---|---|---|---|
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 | |
Morocco | 43132 | COMPOSITIONS AQUEUSES DE SPIRONOLACTONE | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |