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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 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
Bulk Api Vendors:	1
Clinical Trials:	7
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for DUAVEE
DailyMed Link:	DUAVEE at DailyMed

See drug prices for DUAVEE

Generic Entry Opportunity Date for DUAVEE

NDA:

022247

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.

Recent Clinical Trials for DUAVEE

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

Sponsor	Phase
University of North Carolina, Chapel Hill	Phase 4
Foundation of Hope, North Carolina	Phase 4
National Cancer Institute (NCI)	Phase 2

See all DUAVEE clinical trials

Pharmacology for DUAVEE

Drug Class	Estrogen Estrogen Agonist/Antagonist
Mechanism of Action	Estrogen Receptor Agonists Selective Estrogen Receptor Modulators

Synonyms for DUAVEE

Bazedoxifene / conjugated estrogens

Bazedoxifene and conjugated estrogens

Bazedoxifene mixture with conjugated estrogens

S900006280

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	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013		RX	Yes	Yes			Y	Y
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013		RX	Yes	Yes			Y	Y
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013		RX	Yes	Yes			Y
Wyeth Pharms	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	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013

International Patents for DUAVEE

Country	Patent Number	Estimated Expiration
Norway	971815
El Salvador	2008002080
Singapore	151331
Japan	2009035535

Supplementary Protection Certificates for DUAVEE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0802183	364	Finland
0802183	91608	Luxembourg		91608, EXPIRES: 20220415
0802183	SPC/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
0802183	PA2009007,C0802183	Lithuania		PRODUCT NAME: BAZEDOXIFENUM; REGISTRATION NO/DATE: EU/1/09/511/001 - EU/1/09/511/004 20090417