Spironolactone - Generic Drug Details
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What are the generic drug sources for spironolactone and what is the scope of patent protection?
Spironolactone
is the generic ingredient in three branded drugs marketed by Cmp Dev Llc, Pfizer, 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, and Zydus Pharms, and is included in twenty-five 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. Thirty-four suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for spironolactone
International Patents: | 4 |
US Patents: | 8 |
Tradenames: | 3 |
Applicants: | 22 |
NDAs: | 25 |
Drug Master File Entries: | 16 |
Finished Product Suppliers / Packagers: | 34 |
Raw Ingredient (Bulk) Api Vendors: | 84 |
Clinical Trials: | 251 |
Patent Applications: | 6,676 |
Formulation / Manufacturing: | see details |
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 |
---|---|
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Phase 4 |
Second Affiliated Hospital of Nanchang University | N/A |
Fundació Sant Joan de Déu | Phase 2 |
Generic filers with tentative approvals for SPIRONOLACTONE
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 25MG/5ML | SUSPENSION;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for spironolactone
Drug Class | Aldosterone Antagonist |
Mechanism of Action | Aldosterone Antagonists |
Medical Subject Heading (MeSH) Categories 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Actavis Elizabeth | SPIRONOLACTONE | spironolactone | TABLET;ORAL | 040353-003 | Mar 15, 2006 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Vangard | SPIRONOLACTONE | spironolactone | TABLET;ORAL | 087648-001 | Feb 1, 1982 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Ascot | SPIRONOLACTONE | spironolactone | TABLET;ORAL | 087687-001 | Oct 20, 1982 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Accord Hlthcare | SPIRONOLACTONE | spironolactone | TABLET;ORAL | 203512-003 | Sep 19, 2016 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
>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 | |
>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) | See Plans and Pricing |
Morocco | 43132 | COMPOSITIONS AQUEUSES DE SPIRONOLACTONE | See Plans and Pricing |
World Intellectual Property Organization (WIPO) | 2017075463 | See Plans and Pricing | |
European Patent Office | 3368045 | COMPOSITIONS AQUEUSES DE SPIRONOLACTONE (SPIRONOLACTONE AQUEOUS COMPOSITIONS) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
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