BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED - Generic Drug Details

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What are the generic sources for bazedoxifene acetate; estrogens, conjugated and what is the scope of patent protection?

Bazedoxifene acetate; estrogens, conjugated is the generic ingredient in one branded drug marketed by Wyeth Pharms and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bazedoxifene acetate; estrogens, conjugated has twenty-two patent family members in twenty countries.

Two suppliers are listed for this compound.

Summary for BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED

International Patents:	22
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	4
DailyMed Link:	BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED

Generic Entry Date for BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED

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

Sponsor	Phase
Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer	Phase 1

See all BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED clinical trials

Pharmacology for BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED

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

Anatomical Therapeutic Chemical (ATC) Classes for BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED

G03XC	Selective estrogen receptor modulators
G03X	OTHER SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED

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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
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Wyeth Pharms	DUAVEE	bazedoxifene acetate; estrogens, conjugated	TABLET;ORAL	022247-001	Oct 3, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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 BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED

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

International Patents for BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED

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Country	Patent Number	Title	Estimated Expiration
Japan	2009035535	CRYSTALLINE POLYMORPH OF BAZEDOXIFENE ACETATE	⤷ Sign Up
Singapore	151331	CRYSTALLINE POLYMORPH OF A BAZEDOXIFENE ACETATE	⤷ Sign Up
El Salvador	2008002080	POLIMORFO CRISTALINO DE ACETATO DE BAZEDOXIFENO REF. WYTH0084-504 (AM101551)	⤷ Sign Up
Canada	2561010	CORPS POLYMORPHE CRISTALLIN DE BASEDOXIFENE ACETATE (CRYSTALLINE POLYMORPH OF A BAZEDOXIFENE ACETATE)	⤷ Sign Up
Russian Federation	2006132180	КРИСТАЛЛИЧЕСКИЙ ПОЛИМОРФ БАЗЕДОКСИФЕН АЦЕТАТА	⤷ Sign Up
Norway	20065052		⤷ Sign Up
Guatemala	200500078	POLIMORFO CRISTALINO DE ACETATO DE BAZEDOXIFENO	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0802183	SPC/GB09/045	United Kingdom	⤷ Sign Up	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	2009/028	Ireland	⤷ Sign Up	PRODUCT NAME: BAZEDOXIFENE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/09/511/001-004 20090417
0802183	09C0048	France	⤷ Sign Up	PRODUCT NAME: BAZEDOXIFENE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/09/511/001 DU 20090417; REGISTRATION NO/DATE AT EEC: EU/1/09/511/001-004 DU 20090417
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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