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-three 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.
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Questions you can ask:
- What is the 5 year forecast for ALDACTONE?
- What are the global sales for ALDACTONE?
- What is Average Wholesale Price for ALDACTONE?
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: | 2,747 |
| 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 |
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 | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
| Pfizer | ALDACTONE | spironolactone | TABLET;ORAL | 012151-008 | Dec 30, 1982 | AB | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
| Pfizer | ALDACTONE | spironolactone | TABLET;ORAL | 012151-010 | Dec 30, 1983 | AB | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
| >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 |
