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Last Updated: March 1, 2021

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Estradiol hemihydrate - Generic Drug Details

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What are the generic drug sources for estradiol hemihydrate and what is the scope of patent protection?

Estradiol hemihydrate is the generic ingredient in one branded drug marketed by Exeltis Usa Inc and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are seventy-five drug master file entries for estradiol hemihydrate.

Summary for estradiol hemihydrate
Recent Clinical Trials for estradiol hemihydrate

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

Jim Pattison Children's Hospital FoundationPhase 1
University of SaskatchewanPhase 1
Mahidol UniversityPhase 4

See all estradiol hemihydrate clinical trials

US Patents and Regulatory Information for estradiol hemihydrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Exeltis Usa Inc ESTRASORB estradiol hemihydrate EMULSION;TOPICAL 021371-001 Oct 9, 2003 DISCN Yes No   Start Trial   Start Trial   Start 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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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts

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