SULFAMETHIZOLE - Generic Drug Details
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What are the generic sources for sulfamethizole and what is the scope of patent protection?
Sulfamethizole
is the generic ingredient in three branded drugs marketed by Forest Pharms and Wyeth Ayerst, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.There are four drug master file entries for sulfamethizole.
Summary for SULFAMETHIZOLE
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 2 |
| NDAs: | 3 |
| Drug Master File Entries: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 94 |
| Clinical Trials: | 1 |
| DailyMed Link: | SULFAMETHIZOLE at DailyMed |
Recent Clinical Trials for SULFAMETHIZOLE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Louisville | Early Phase 1 |
| James Graham Brown Cancer Center | Early Phase 1 |
| Julio Ramirez | Early Phase 1 |
Medical Subject Heading (MeSH) Categories for SULFAMETHIZOLE
Anatomical Therapeutic Chemical (ATC) Classes for SULFAMETHIZOLE
US Patents and Regulatory Information for SULFAMETHIZOLE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Forest Pharms | MICROSUL | sulfamethizole | TABLET;ORAL | 086012-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Wyeth Ayerst | THIOSULFIL | sulfamethizole | TABLET;ORAL | 008565-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Wyeth Ayerst | THIOSULFIL | sulfamethizole | TABLET;ORAL | 008565-004 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Forest Pharms | PROKLAR | sulfamethizole | TABLET;ORAL | 080273-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
