SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE Drug Patent Profile
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When do Spironolactone And Hydrochlorothiazide patents expire, and what generic alternatives are available?
Spironolactone And Hydrochlorothiazide is a drug marketed by Ascot, Chartwell Rx, Mutual Pharm, Mylan, Purepac Pharm, Sun Pharm Industries, Superpharm, and Watson Labs. and is included in eight NDAs.
The generic ingredient in SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; spironolactone. There are thirty-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; spironolactone profile page.
Summary for SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
| US Patents: | 0 |
| Applicants: | 8 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 5 |
| Clinical Trials: | 9 |
| Patent Applications: | 31 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE? | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE excipients list |
| DailyMed Link: | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE at DailyMed |
Recent Clinical Trials for SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Chiang Mai University | Phase 3 |
| Medical University of Bialystok | N/A |
| Shanghai Jiao Tong University School of Medicine | Phase 4 |
See all SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE clinical trials
Pharmacology for SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
| Drug Class | Aldosterone Antagonist Thiazide Diuretic |
| Mechanism of Action | Aldosterone Antagonists |
| Physiological Effect | Increased Diuresis |
Anatomical Therapeutic Chemical (ATC) Classes for SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
US Patents and Regulatory Information for SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ascot | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; spironolactone | TABLET;ORAL | 088025-001 | Nov 23, 1984 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Superpharm | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; spironolactone | TABLET;ORAL | 089137-001 | Aug 26, 1985 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mylan | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; spironolactone | TABLET;ORAL | 086513-001 | Approved Prior to Jan 1, 1982 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Watson Labs | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; spironolactone | TABLET;ORAL | 087398-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Chartwell Rx | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; spironolactone | TABLET;ORAL | 086881-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mutual Pharm | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; spironolactone | TABLET;ORAL | 087267-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sun Pharm Industries | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; spironolactone | TABLET;ORAL | 089534-001 | Jul 2, 1987 | AB | RX | No | No | ⤷ 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 |
