Details for New Drug Application (NDA): 203505

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NDA 203505 describes OSPHENA, which is a drug marketed by Duchesnay and is included in one NDA. It is available from two suppliers. There are seven patents protecting this drug. Additional details are available on the OSPHENA profile page.

The generic ingredient in OSPHENA is ospemifene. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ospemifene profile page.

Summary for 203505

Tradename:	OSPHENA
Applicant:	Duchesnay
Ingredient:	ospemifene
Patents:	7

Pharmacology for NDA: 203505

Mechanism of Action	Selective Estrogen Receptor Modulators

Suppliers and Packaging for NDA: 203505

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OSPHENA	ospemifene	TABLET;ORAL	203505	NDA	Duchesnay USA, Inc.	55494-580	55494-580-18	1 BLISTER PACK in 1 PACKAGE (55494-580-18) / 15 TABLET, FILM COATED in 1 BLISTER PACK
OSPHENA	ospemifene	TABLET;ORAL	203505	NDA	Duchesnay USA, Inc.	55494-580	55494-580-30	30 TABLET, FILM COATED in 1 BOTTLE (55494-580-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	60MG
Approval Date:	Feb 26, 2013	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jul 21, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE
Patent:	⤷ Sign Up	Patent Expiration:	Jul 21, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE, SYMPTOMS OF VULVAR AND VAGINAL ATROPHY, ASSOCIATED WITH MENOPAUSE
Patent:	⤷ Sign Up	Patent Expiration:	Aug 11, 2026	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE

Expired US Patents for NDA 203505

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	⤷ Sign Up	⤷ Sign Up
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	⤷ Sign Up	⤷ Sign Up
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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