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-four 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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 |
| World Intellectual Property Organization (WIPO) | 2017075463 | ⤷ Sign Up | |
| Morocco | 43132 | COMPOSITIONS AQUEUSES DE SPIRONOLACTONE | ⤷ Sign Up |
| Canada | 3003028 | COMPOSITIONS AQUEUSES DE SPIRONOLACTONE (SPIRONOLACTONE AQUEOUS COMPOSITIONS) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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