Sulfamethizole - Generic Drug Details
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What are the generic sources for sulfamethizole and what is the scope of freedom to operate?
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 |
| Patent Applications: | 6,487 |
| DailyMed Link: | sulfamethizole at DailyMed |
Recent Clinical Trials for sulfamethizole
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Julio Ramirez | Early Phase 1 |
| University of Louisville | Early Phase 1 |
| James Graham Brown Cancer Center | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Wyeth Ayerst | THIOSULFIL | sulfamethizole | TABLET;ORAL | 008565-004 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Forest Pharms | PROKLAR | sulfamethizole | TABLET;ORAL | 080273-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Wyeth Ayerst | THIOSULFIL | sulfamethizole | TABLET;ORAL | 008565-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Forest Pharms | MICROSUL | sulfamethizole | TABLET;ORAL | 086012-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
