Sulfisoxazole - Generic Drug Details
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What are the generic sources for sulfisoxazole and what is the scope of patent protection?
Sulfisoxazole
is the generic ingredient in nine branded drugs marketed by Roche, Mk Labs, Alra, Parke Davis, Ani Pharms, Barr, Heather, Impax Labs, Lannett, Lederle, Pharmeral, Purepac Pharm, Rising, Roxane, Valeant Pharm Intl, Vitarine, Watson Labs, West Ward, Solvay, and Sola Barnes Hind, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.There are three drug master file entries for sulfisoxazole.
Summary for sulfisoxazole
| US Patents: | 0 |
| Tradenames: | 9 |
| Applicants: | 20 |
| NDAs: | 24 |
| Drug Master File Entries: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 125 |
| Clinical Trials: | 2 |
| Patent Applications: | 5,607 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | sulfisoxazole at DailyMed |
Recent Clinical Trials for sulfisoxazole
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Federal University of São Paulo | Phase 4 |
| Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
| University of Louisville | Early Phase 1 |
Medical Subject Heading (MeSH) Categories for sulfisoxazole
US Patents and Regulatory Information for sulfisoxazole
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Impax Labs | SULFISOXAZOLE | sulfisoxazole | TABLET;ORAL | 080109-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Roche | GANTRISIN | sulfisoxazole diolamine | SOLUTION/DROPS;OPHTHALMIC | 007757-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Roche | GANTRISIN | sulfisoxazole | TABLET;ORAL | 006525-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Roche | GANTRISIN PEDIATRIC | sulfisoxazole acetyl | SUSPENSION;ORAL | 009182-004 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Valeant Pharm Intl | SULFISOXAZOLE | sulfisoxazole | TABLET;ORAL | 080268-002 | Approved Prior to Jan 1, 1982 | DISCN | 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 |
