ESTRADIOL HEMIHYDRATE - Generic Drug Details

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What are the generic 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 three drug master file entries for estradiol hemihydrate.

Summary for ESTRADIOL HEMIHYDRATE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	3
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	4
Patent Applications:	7,013
DailyMed Link:	ESTRADIOL HEMIHYDRATE at DailyMed

Recent Clinical Trials for ESTRADIOL HEMIHYDRATE

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

Sponsor	Phase
Jim Pattison Children's Hospital Foundation	Phase 1
University of Saskatchewan	Phase 1
Mahidol University	Phase 4

See all ESTRADIOL HEMIHYDRATE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ESTRADIOL HEMIHYDRATE

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for ESTRADIOL HEMIHYDRATE

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Glossary

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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	⤷ 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

Expired US Patents for ESTRADIOL HEMIHYDRATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Exeltis Usa Inc	ESTRASORB	estradiol hemihydrate	EMULSION;TOPICAL	021371-001	Oct 9, 2003	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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