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: | 46 |
Patent Applications: | 6,353 |
Formulation / Manufacturing: | see details |
DailyMed Link: | estrone at DailyMed |
Recent Clinical Trials for estrone
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Maryland, Baltimore | Early Phase 1 |
InnovaGyn, Inc. | Phase 2 |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 2 |
Medical Subject Heading (MeSH) Categories 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Parkedale | THEELIN | estrone | INJECTABLE;INJECTION | 003977-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Watson Labs | ESTRONE | estrone | INJECTABLE;INJECTION | 083397-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Dr Reddys | ESTRONE | estrone | INJECTABLE;INJECTION | 085239-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Parkedale | THEELIN | estrone | INJECTABLE;INJECTION | 003977-001 | 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 |