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Last Updated: January 20, 2020

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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.

US ANDA Litigation and Generic Entry Outlook for Duavee

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Duavee was eligible for patent challenges on October 13th, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 10th, 2027. This may change due to patent challenges or generic licensing.

Summary for DUAVEE
Drug patent expirations by year for DUAVEE
Drug Prices for DUAVEE

See drug prices for DUAVEE

Generic Entry Opportunity Date for DUAVEE
Generic Entry Date for DUAVEE*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Foundation of Hope, North CarolinaPhase 4
University of North Carolina, Chapel HillPhase 4
PfizerPhase 2

See all DUAVEE clinical trials

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

Supplementary Protection Certificates for DUAVEE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0802183 2009/028 Ireland   Start Trial PRODUCT NAME: BAZEDOXIFENE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/09/511/001-004 20090417
0802183 C00802183/01 Switzerland   Start Trial PRODUCT NAME: BAZEDOXIFEN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58732 12.01.2010
0802183 91608 Luxembourg   Start Trial 91608, EXPIRES: 20220415
0802183 SPC/GB09/045 United Kingdom   Start Trial 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 CA 2009 00035 Denmark   Start Trial
0802183 09C0048 France   Start Trial 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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