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Last Updated: March 18, 2024

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DUAVEE Drug Patent 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-two patent family members in twenty 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.

DrugPatentWatch® 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

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
VA Office of Research and DevelopmentPhase 2
Penn State UniversityPhase 4
The John B. Pierce LaboratoryPhase 4

See all DUAVEE clinical trials

US Patents and Regulatory Information for DUAVEE

DUAVEE is protected by four US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DUAVEE is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting DUAVEE

2-phenyl-1-[4-(2-aminoethoxy)-benzyl]-indole and estrogen formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS

2-phenyl-1-[4-(2-aminoethoxy)-benzyl]-indole and estrogen formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE

Crystalline polymorph of bazedoxifene acetate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS

Crystalline polymorph of bazedoxifene acetate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE

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

International Patents for DUAVEE

When does loss-of-exclusivity occur for DUAVEE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 8527
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 05233133
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0509191
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 61010
Estimated Expiration: ⤷  Try a Trial

China

Patent: 38272
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 15
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 066911
Estimated Expiration: ⤷  Try a Trial

El Salvador

Patent: 08002080
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 32890
Estimated Expiration: ⤷  Try a Trial

Guatemala

Patent: 0500078
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 07532560
Estimated Expiration: ⤷  Try a Trial

Patent: 09035535
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 065052
Estimated Expiration: ⤷  Try a Trial

Panama

Patent: 29101
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 060676
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 06132180
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 1331
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 060135866
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 46105
Estimated Expiration: ⤷  Try a Trial

Patent: 0606149
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 703
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering DUAVEE around the world.

Country Patent Number Title Estimated Expiration
Czech Republic 291701 Indolové deriváty s estrogenním účinkem a farmaceutický prostředek s jejich obsahem (Indole derivatives exhibiting estrogenic activity and pharmaceutical composition containing such derivatives) ⤷  Try a Trial
Brazil PI0509191 polimorfo cristalino, composição, métodos de preparar forma a polimórfica de acetato de bazedoxifeno, de tratar um mamìfero possuindo uma doença ou sìndrome associada com deficiência de estrogênio ou excesso de estrogênio, e com proliferação ou desenvolvimento anormal de tecidos endometriais, cáncer de mama em um mamìfero, e uma mulher pós-menopausal para um ou vários distúrbios vasomotores, de abaixar colesterol em um mamìfero, e de inibir perda óssea em um mamìfero, e, forma a polimorfa cristalina de acetato de bazedoxifeno ⤷  Try a Trial
Denmark 0802183 ⤷  Try a Trial
Israel 120701 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DUAVEE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0802183 300416 Netherlands ⤷  Try a Trial 300416, 20170415, EXPIRES: 20220414
0802183 C00802183/01 Switzerland ⤷  Try a Trial PRODUCT NAME: BAZEDOXIFEN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58732 12.01.2010
0802183 91608 Luxembourg ⤷  Try a Trial 91608, EXPIRES: 20220415
0802183 PA2009007,C0802183 Lithuania ⤷  Try a Trial PRODUCT NAME: BAZEDOXIFENUM; REGISTRATION NO/DATE: EU/1/09/511/001 - EU/1/09/511/004 20090417
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.