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Last Updated: December 4, 2020

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DUAVEE Drug Profile

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Which patents cover Duavee, and when can generic versions of Duavee launch?

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

This drug has twenty-three patent family members in twenty-one 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

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

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

Indicators of Generic Entry

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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
Carol Fabian, MDEarly Phase 1
Breast Cancer Research FoundationEarly Phase 1
Foundation of Hope, North CarolinaPhase 4

See all DUAVEE clinical trials

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   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
>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 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
0802183 300416 Netherlands   Start Trial 300416, 20170415, EXPIRES: 20220414
0802183 CA 2009 00035 Denmark   Start Trial
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 PA2009007,C0802183 Lithuania   Start Trial PRODUCT NAME: BAZEDOXIFENUM; REGISTRATION NO/DATE: EU/1/09/511/001 - EU/1/09/511/004 20090417
0802183 91608 Luxembourg   Start Trial 91608, EXPIRES: 20220415
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
Express Scripts
Medtronic
McKesson
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.