Tolbutamide - Generic Drug Details
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What are the generic drug sources for tolbutamide and what is the scope of patent protection?
Tolbutamide
is the generic ingredient in three branded drugs marketed by Pharmacia And Upjohn, Alra, Ani Pharms, Ascot, Barr, Chartwell Rx, Dava Pharms Inc, Norvium Bioscience, Parke Davis, Purepac Pharm, Sandoz, Superpharm, Vangard, and Watson Labs, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.There are fifteen drug master file entries for tolbutamide.
Summary for tolbutamide
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 14 |
| NDAs: | 18 |
| Drug Master File Entries: | 15 |
| Raw Ingredient (Bulk) Api Vendors: | 121 |
| Clinical Trials: | 30 |
| Patent Applications: | 7,287 |
| What excipients (inactive ingredients) are in tolbutamide? | tolbutamide excipients list |
| DailyMed Link: | tolbutamide at DailyMed |
Recent Clinical Trials for tolbutamide
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pfizer | Phase 1 |
| Radboud University | Phase 1 |
| University of Illinois at Chicago | Phase 1 |
Medical Subject Heading (MeSH) Categories for tolbutamide
Anatomical Therapeutic Chemical (ATC) Classes for tolbutamide
US Patents and Regulatory Information for tolbutamide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Parke Davis | TOLBUTAMIDE | tolbutamide | TABLET;ORAL | 086047-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Norvium Bioscience | TOLBUTAMIDE | tolbutamide | TABLET;ORAL | 086445-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Barr | TOLBUTAMIDE | tolbutamide | TABLET;ORAL | 087121-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Dava Pharms Inc | TOLBUTAMIDE | tolbutamide | TABLET;ORAL | 086926-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pharmacia And Upjohn | ORINASE | tolbutamide | TABLET;ORAL | 010670-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pharmacia And Upjohn | ORINASE DIAGNOSTIC | tolbutamide sodium | INJECTABLE;INJECTION | 012095-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Alra | TOLBUTAMIDE | tolbutamide | TABLET;ORAL | 086141-001 | 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 |
