Estradiol; norgestimate - Generic Drug Details

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What are the generic sources for estradiol; norgestimate and what is the scope of freedom to operate?

Estradiol; norgestimate is the generic ingredient in two branded drugs marketed by Barr and Teva Womens, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for estradiol; norgestimate

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Clinical Trials:	29
DailyMed Link:	estradiol; norgestimate at DailyMed

Recent Clinical Trials for estradiol; norgestimate

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

Sponsor	Phase
Benha University	Phase 2/Phase 3
Amgen	Phase 1
Gilead Sciences	Phase 1

See all estradiol; norgestimate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for estradiol; norgestimate

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; norgestimate

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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
Teva Womens	PREFEST	estradiol; norgestimate	TABLET;ORAL	021040-001	Oct 22, 1999		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Barr	ESTRADIOL AND NORGESTIMATE	estradiol; norgestimate	TABLET;ORAL	076812-001	Apr 29, 2005		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

Expired US Patents for estradiol; norgestimate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Womens	PREFEST	estradiol; norgestimate	TABLET;ORAL	021040-001	Oct 22, 1999	⤷ Sign Up	⤷ Sign Up
Teva Womens	PREFEST	estradiol; norgestimate	TABLET;ORAL	021040-001	Oct 22, 1999	⤷ Sign Up	⤷ Sign Up
Teva Womens	PREFEST	estradiol; norgestimate	TABLET;ORAL	021040-001	Oct 22, 1999	⤷ Sign Up	⤷ Sign Up
Teva Womens	PREFEST	estradiol; norgestimate	TABLET;ORAL	021040-001	Oct 22, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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