SPIRONOLACTONE Drug Patent Profile
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Which patents cover Spironolactone, and what generic alternatives are available?
Spironolactone is a drug marketed by Amneal, Accord Hlthcare, Actavis Elizabeth, Amneal Pharms, Ascot, Aurobindo Pharma, Chartwell Rx, Ivax Pharms, Jubilant Generics, Lederle, Mutual Pharm, Mylan, Oxford Pharms, Purepac Pharm, Sun Pharm Industries, Superpharm, Upsher Smith, Vangard, Warner Chilcott, Watson Labs, Zydus Pharms, Parke Davis, and Usl Pharma. and is included in forty-one NDAs.
The generic ingredient in SPIRONOLACTONE is hydrochlorothiazide; spironolactone. There are thirty-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; spironolactone profile page.
Summary for SPIRONOLACTONE
US Patents: | 0 |
Applicants: | 23 |
NDAs: | 41 |
Finished Product Suppliers / Packagers: | 38 |
Raw Ingredient (Bulk) Api Vendors: | 87 |
Clinical Trials: | 259 |
Patent Applications: | 3,980 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information 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 |
---|---|
National Key Research and Development Program of China | Phase 4 |
Vifor Pharma | Phase 3 |
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Phase 4 |
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
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 |