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
Summary for DUAVEE
International Patents: | 22 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 12 |
Patent Applications: | 5 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for DUAVEE |
What excipients (inactive ingredients) are in DUAVEE? | DUAVEE excipients list |
DailyMed Link: | DUAVEE at DailyMed |
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
Sponsor | Phase |
---|---|
VA Office of Research and Development | Phase 2 |
Penn State University | Phase 4 |
The John B. Pierce Laboratory | Phase 4 |
Pharmacology for DUAVEE
Drug Class | Estrogen Agonist/Antagonist Estrogen |
Mechanism of Action | Estrogen Receptor Agonists Selective Estrogen Receptor Modulators |
Anatomical Therapeutic Chemical (ATC) Classes for DUAVEE
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 |