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DUAVEE Drug Profile

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When do Duavee patents expire, and when can generic versions of Duavee launch?

Duavee is a drug marketed by Wyeth Pharms Pfizer and is included in one NDA. There are four patents protecting this drug.

This drug has sixty-four patent family members in forty countries.

The generic ingredient in DUAVEE is bazedoxifene acetate; estrogens, conjugated. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bazedoxifene acetate; estrogens, conjugated profile page.

Summary for DUAVEE

International Patents:	64
US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Clinical Trials:	6
Formulation / Manufacturing:	see details
Drug Prices:	see details
DailyMed Link:	DUAVEE at DailyMed

Pharmacology for DUAVEE

Ingredient-type	Estrogens, Conjugated (USP)
Drug Class	Estrogen Estrogen Agonist/Antagonist
Mechanism of Action	Estrogen Receptor Agonists Selective Estrogen Receptor Modulators

US Patents and Regulatory Information for DUAVEE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms Pfizer	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013		RX	Yes	Yes			Y
Wyeth Pharms Pfizer	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013		RX	Yes	Yes
Wyeth Pharms Pfizer	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013		RX	Yes	Yes			Y	Y
Wyeth Pharms Pfizer	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013		RX	Yes	Yes			Y

Expired US Patents for DUAVEE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms Pfizer	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013

Non-Orange Book US Patents for DUAVEE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,232,307	Tissue selective compounds in the treatment of ovarian cancer
6,291,451	2-phenyl-1-[4-(2-aminoethoxy)-benzyl]-indoles as estrogenic agents
6,326,367	2-phenyl-1-[4-(2-aminoethoxy)-benzyl]-indoles as estrogenic agents
6,127,404	Tissue selective compounds in the treatment of endometrial proliferation

International Patents for DUAVEE

Country	Document Number	Estimated Expiration
Canada	2203078
Netherlands	300416
Norway	20065052
Norway	2009025

Supplementary Protection Certificates for DUAVEE

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0802183/01	Switzerland		PRODUCT NAME: BAZEDOXIFEN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58732 12.01.2010
2009007	Lithuania		PRODUCT NAME: BAZEDOXIFENUM; REGISTRATION NO/DATE: EU/1/09/511/001 - EU/1/09/511/004 20090417
C/GB09/045	United Kingdom		PRODUCT NAME: BAZEDOXIFENE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/09/511/001 20090417; UK EU/1/09/511/002 20090417; UK EU/1/09/511/003 20090417; UK EU/1/09/511/004 20090417
4	Finland