Diethylstilbestrol - Generic Drug Details
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What are the generic sources for diethylstilbestrol and what is the scope of freedom to operate?
Diethylstilbestrol
is the generic ingredient in four branded drugs marketed by Bristol Myers Squibb, Lilly, Tablicaps, and Bayer Pharms, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.There are twenty-six drug master file entries for diethylstilbestrol.
Summary for diethylstilbestrol
| US Patents: | 0 |
| Tradenames: | 4 |
| Applicants: | 4 |
| NDAs: | 11 |
| Drug Master File Entries: | 26 |
| Raw Ingredient (Bulk) Api Vendors: | 119 |
| Clinical Trials: | 5 |
| Patent Applications: | 7,575 |
| DailyMed Link: | diethylstilbestrol at DailyMed |
Recent Clinical Trials for diethylstilbestrol
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Elysium Health, Inc. | N/A |
| University of South Alabama | N/A |
| Janssen Research & Development, LLC | Phase 2 |
Medical Subject Heading (MeSH) Categories for diethylstilbestrol
Anatomical Therapeutic Chemical (ATC) Classes for diethylstilbestrol
US Patents and Regulatory Information for diethylstilbestrol
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lilly | DIETHYLSTILBESTROL | diethylstilbestrol | TABLET;ORAL | 004041-005 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Lilly | DIETHYLSTILBESTROL | diethylstilbestrol | TABLET, DELAYED RELEASE;ORAL | 004039-006 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Tablicaps | STILBESTROL | diethylstilbestrol | TABLET, DELAYED RELEASE;ORAL | 083003-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bristol Myers Squibb | STILBESTROL | diethylstilbestrol | SUPPOSITORY;VAGINAL | 004056-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bristol Myers Squibb | STILBETIN | diethylstilbestrol | TABLET, DELAYED RELEASE;ORAL | 004056-011 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bristol Myers Squibb | STILBESTROL | diethylstilbestrol | INJECTABLE;INJECTION | 004056-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Lilly | DIETHYLSTILBESTROL | diethylstilbestrol | TABLET;ORAL | 004041-002 | 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 |
