Tolbutamide - Generic Drug Details
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What are the generic sources for tolbutamide and what is the scope of freedom to operate?
Tolbutamide
is the generic ingredient in three branded drugs marketed by Pharmacia And Upjohn, Alra, Ani Pharms, Ascot, Barr, Chartwell Rx, Dava Pharms Inc, Mylan Pharms Inc, 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: | 6,877 |
| Formulation / Manufacturing: | see details |
| 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 |
| Oregon State University | Phase 1 |
Medical Subject Heading (MeSH) Categories 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Purepac Pharm | TOLBUTAMIDE | tolbutamide | TABLET;ORAL | 088950-001 | Jun 17, 1985 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Ascot | TOLBUTAMIDE | tolbutamide | TABLET;ORAL | 087541-001 | Mar 1, 1983 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sandoz | TOLBUTAMIDE | tolbutamide | TABLET;ORAL | 012678-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Pharmacia And Upjohn | ORINASE | tolbutamide | TABLET;ORAL | 010670-002 | 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 |
