FLUOXYMESTERONE - Generic Drug Details
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What are the generic sources for fluoxymesterone and what is the scope of freedom to operate?
Fluoxymesterone
is the generic ingredient in four branded drugs marketed by Valeant Pharm Intl, Upsher Smith Labs, Watson Labs, Pharmacia And Upjohn, and Bristol Myers Squibb, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.There are three drug master file entries for fluoxymesterone.
Summary for FLUOXYMESTERONE
| US Patents: | 0 |
| Tradenames: | 4 |
| Applicants: | 5 |
| NDAs: | 8 |
| Drug Master File Entries: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 48 |
| Clinical Trials: | 2 |
| Patent Applications: | 7,007 |
| Drug Prices: | Drug price trends for FLUOXYMESTERONE |
| What excipients (inactive ingredients) are in FLUOXYMESTERONE? | FLUOXYMESTERONE excipients list |
| DailyMed Link: | FLUOXYMESTERONE at DailyMed |
Recent Clinical Trials for FLUOXYMESTERONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Federal University of São Paulo | Phase 4 |
| Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
| ASCEND Therapeutics | Phase 2 |
Medical Subject Heading (MeSH) Categories for FLUOXYMESTERONE
Anatomical Therapeutic Chemical (ATC) Classes for FLUOXYMESTERONE
US Patents and Regulatory Information for FLUOXYMESTERONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bristol Myers Squibb | ORA-TESTRYL | fluoxymesterone | TABLET;ORAL | 011359-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs | FLUOXYMESTERONE | fluoxymesterone | TABLET;ORAL | 088260-001 | Dec 6, 1983 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pharmacia And Upjohn | HALOTESTIN | fluoxymesterone | TABLET;ORAL | 010611-010 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs | FLUOXYMESTERONE | fluoxymesterone | TABLET;ORAL | 088309-001 | Dec 6, 1983 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Upsher Smith Labs | FLUOXYMESTERONE | fluoxymesterone | TABLET;ORAL | 088342-001 | Oct 21, 1983 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bristol Myers Squibb | ORA-TESTRYL | fluoxymesterone | TABLET;ORAL | 011359-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Valeant Pharm Intl | FLUOXYMESTERONE | fluoxymesterone | TABLET;ORAL | 088221-001 | May 5, 1983 | 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 |
