Details for New Drug Application (NDA): 021633

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NDA 021633 describes FEMTRACE, which is a drug marketed by Apil and is included in one NDA. There is one patent protecting this drug. Additional details are available on the FEMTRACE profile page.

The generic ingredient in FEMTRACE is estradiol acetate. There are seventy-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estradiol acetate profile page.

Summary for 021633

Tradename:	FEMTRACE
Applicant:	Apil
Ingredient:	estradiol acetate
Patents:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 021633

Generic Entry Date for 021633^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 7,572,779 Dosage: TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.45MG
Approval Date:	Aug 20, 2004	TE:		RLD:	Yes
Patent:	7,572,779	Patent Expiration:	Oct 2, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.9MG
Approval Date:	Aug 20, 2004	TE:		RLD:	Yes
Patent:	7,572,779	Patent Expiration:	Oct 2, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1.8MG
Approval Date:	Aug 20, 2004	TE:		RLD:	Yes
Patent:	7,572,779	Patent Expiration:	Oct 2, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE

Expired US Patents for NDA 021633

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-001	Aug 20, 2004	6,962,908	⤷ Subscribe
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004	7,799,771	⤷ Subscribe
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004	6,962,908	⤷ Subscribe
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-002	Aug 20, 2004	7,799,771	⤷ Subscribe
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-001	Aug 20, 2004	7,799,771	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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