ESTRONE - Generic Drug Details
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What are the generic drug sources for estrone and what is the scope of freedom to operate?
Estrone
is the generic ingredient in four branded drugs marketed by Wyeth Ayerst, Dr Reddys, Watson Labs, and Parkedale, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.There are nine drug master file entries for estrone.
Summary for ESTRONE
| US Patents: | 0 |
| Tradenames: | 4 |
| Applicants: | 4 |
| NDAs: | 5 |
| Drug Master File Entries: | 9 |
| Raw Ingredient (Bulk) Api Vendors: | 106 |
| Clinical Trials: | 47 |
| Patent Applications: | 6,287 |
| DailyMed Link: | ESTRONE at DailyMed |
Recent Clinical Trials for ESTRONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Biòs Farmacêutica | N/A |
| Science Valley Research Institute | N/A |
| University of Maryland, Baltimore | Early Phase 1 |
Medical Subject Heading (MeSH) Categories for ESTRONE
Anatomical Therapeutic Chemical (ATC) Classes for ESTRONE
US Patents and Regulatory Information for ESTRONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs | NATURAL ESTROGENIC SUBSTANCE-ESTRONE | estrone | INJECTABLE;INJECTION | 085237-001 | Nov 23, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Parkedale | THEELIN | estrone | INJECTABLE;INJECTION | 003977-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Dr Reddys | ESTRONE | estrone | INJECTABLE;INJECTION | 085239-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs | ESTRONE | estrone | INJECTABLE;INJECTION | 083397-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Wyeth Ayerst | ESTROGENIC SUBSTANCE | estrone | INJECTABLE;INJECTION | 083488-001 | 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 |
