SPIRONOLACTONE - Generic Drug Details
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What are the generic sources for spironolactone and what is the scope of freedom to operate?
Spironolactone
is the generic ingredient in three branded drugs marketed by Cmp Dev Llc, Amneal, Pfizer, Accord Hlthcare, Actavis Elizabeth, Amneal Pharms, Ascot, Aurobindo Pharma, Chartwell Rx, Ivax Pharms, Jubilant Generics, Lederle, Mutual Pharm, Mylan, Norvium Bioscience, Oxford Pharms, Purepac Pharm, Sun Pharm Industries, Superpharm, Upsher Smith, Vangard, Warner Chilcott, Watson Labs, and Zydus Pharms, and is included in twenty-six NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Spironolactone has four patent family members in four countries.
There are sixteen drug master file entries for spironolactone. Forty-three suppliers are listed for this compound.
Summary for SPIRONOLACTONE
International Patents: | 4 |
US Patents: | 8 |
Tradenames: | 3 |
Applicants: | 24 |
NDAs: | 26 |
Drug Master File Entries: | 16 |
Finished Product Suppliers / Packagers: | 43 |
Raw Ingredient (Bulk) Api Vendors: | 87 |
Clinical Trials: | 263 |
Patent Applications: | 6,730 |
Drug Prices: | Drug price trends for SPIRONOLACTONE |
Drug Sales Revenues: | Drug sales revenues for SPIRONOLACTONE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SPIRONOLACTONE |
What excipients (inactive ingredients) are in SPIRONOLACTONE? | SPIRONOLACTONE excipients list |
DailyMed Link: | SPIRONOLACTONE at DailyMed |
Recent Clinical Trials for SPIRONOLACTONE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
CMP Development, LLC | Phase 4 |
University of California, San Francisco | Phase 2 |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) | N/A |
Pharmacology for SPIRONOLACTONE
Drug Class | Aldosterone Antagonist |
Mechanism of Action | Aldosterone Antagonists |
Medical Subject Heading (MeSH) Categories for SPIRONOLACTONE
Anatomical Therapeutic Chemical (ATC) Classes for SPIRONOLACTONE
Paragraph IV (Patent) Challenges for SPIRONOLACTONE
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 SPIRONOLACTONE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jubilant Generics | SPIRONOLACTONE | spironolactone | TABLET;ORAL | 203253-003 | Apr 23, 2014 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Zydus Pharms | SPIRONOLACTONE | spironolactone | TABLET;ORAL | 205936-001 | Jul 18, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Mylan | SPIRONOLACTONE | spironolactone | TABLET;ORAL | 040424-001 | Aug 20, 2001 | AB | RX | No | No | ⤷ 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 SPIRONOLACTONE
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 SPIRONOLACTONE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 3003028 | COMPOSITIONS AQUEUSES DE SPIRONOLACTONE (SPIRONOLACTONE AQUEOUS COMPOSITIONS) | ⤷ Sign Up |
Morocco | 43132 | COMPOSITIONS AQUEUSES DE SPIRONOLACTONE | ⤷ Sign Up |
European Patent Office | 3368045 | COMPOSITIONS AQUEUSES DE SPIRONOLACTONE (SPIRONOLACTONE AQUEOUS COMPOSITIONS) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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