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, Norvium Bioscience, 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. Seven suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; spironolactone profile page.
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Summary for SPIRONOLACTONE
| US Patents: | 0 |
| Applicants: | 24 |
| NDAs: | 41 |
| Finished Product Suppliers / Packagers: | 40 |
| Raw Ingredient (Bulk) Api Vendors: | 87 |
| Clinical Trials: | 263 |
| Patent Applications: | 3,086 |
| 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 |
See drug prices for SPIRONOLACTONE
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zydus Pharms | SPIRONOLACTONE | spironolactone | TABLET;ORAL | 205936-002 | Jul 18, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sun Pharm Industries | SPIRONOLACTONE | spironolactone | TABLET;ORAL | 089424-002 | Aug 11, 1999 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Superpharm | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; spironolactone | TABLET;ORAL | 089137-001 | Aug 26, 1985 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mutual Pharm | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; spironolactone | TABLET;ORAL | 087267-001 | Approved Prior to Jan 1, 1982 | DISCN | 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 |
