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Last Updated: March 28, 2024

Estrone - Generic Drug Details


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What are the generic sources for estrone and what is the scope of patent protection?

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.

Recent Clinical Trials for estrone

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Maryland, BaltimoreEarly Phase 1
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 2
InnovaGyn, Inc.Phase 2

See all estrone clinical trials

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
Parkedale THEELIN estrone INJECTABLE;INJECTION 003977-003 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

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