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Generated: August 22, 2017
What are the generic sources for spironolactone and what is the scope of spironolactone freedom to operate?
Spironolactone is the generic ingredient in two branded drugs marketed by Ivax Pharms, Sandoz, Accord Hlthcare, Mylan, Sun Pharm Inds, Amneal Pharms, Lederle, Vangard, Vintage, Gd Searle Llc, Warner Chilcott, Actavis Elizabeth, Jubilant Generics, Purepac Pharm, Upsher Smith, Superpharm, Mutual Pharm, Watson Labs, Ascot, and Orion Corp Orion, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.| Tradenames: | 2 |
| Patents: | 0 |
| Applicants: | 20 |
| NDAs: | 23 |
| Drug Master File Entries: see list | 15 |
| Suppliers / Packagers: see list | 40 |
| Bulk Api Vendors: see list | 45 |
| Clinical Trials: see list | 159 |
| Patent Applications: see list | 6,111 |
| Therapeutic Class: | Cardiovascular Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | spironolactone at DailyMed |
| Drug Class | Aldosterone Antagonist |
| Mechanism of Action | Aldosterone Antagonists |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sandoz | SPIRONOLACTONE | spironolactone | TABLET;ORAL | 086809-001 | Approved Prior to Jan 1, 1982 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Lederle | SPIRONOLACTONE | spironolactone | TABLET;ORAL | 087634-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Actavis Elizabeth | SPIRONOLACTONE | spironolactone | TABLET;ORAL | 040353-002 | Jul 29, 1999 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Sun Pharm Inds | SPIRONOLACTONE | spironolactone | TABLET;ORAL | 089424-001 | Jul 23, 1986 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Sun Pharm Inds | SPIRONOLACTONE | spironolactone | TABLET;ORAL | 089424-002 | Aug 11, 1999 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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