ALDACTONE Drug Patent Profile
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Which patents cover Aldactone, and what generic alternatives are available?
Aldactone is a drug marketed by Pfizer and is included in one NDA.
The generic ingredient in ALDACTONE is spironolactone. There are sixteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the spironolactone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Aldactone
A generic version of ALDACTONE was approved as spironolactone by SUN PHARM INDUSTRIES on July 23rd, 1986.
Summary for ALDACTONE
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 87 |
Clinical Trials: | 47 |
Patent Applications: | 2,294 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ALDACTONE |
What excipients (inactive ingredients) are in ALDACTONE? | ALDACTONE excipients list |
DailyMed Link: | ALDACTONE at DailyMed |
Recent Clinical Trials for ALDACTONE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Thomas Jefferson University | Phase 1 |
Hong Kong Children's Hospital | Phase 2 |
The University of Hong Kong | Phase 2 |
Pharmacology for ALDACTONE
Drug Class | Aldosterone Antagonist |
Mechanism of Action | Aldosterone Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for ALDACTONE
US Patents and Regulatory Information for ALDACTONE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pfizer | ALDACTONE | spironolactone | TABLET;ORAL | 012151-009 | Dec 30, 1983 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Pfizer | ALDACTONE | spironolactone | TABLET;ORAL | 012151-008 | Dec 30, 1982 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Pfizer | ALDACTONE | spironolactone | TABLET;ORAL | 012151-010 | Dec 30, 1983 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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 ALDACTONE
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 |