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: | 11 |
| 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 Generic Entry Opportunity Date for DUAVEE
*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 |
| The John B. Pierce Laboratory | Phase 4 |
| Penn State University | 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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
2-phenyl-1-[4-(2-aminoethoxy)-benzyl]-indole and estrogen formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
Crystalline polymorph of bazedoxifene acetate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
Crystalline polymorph of bazedoxifene acetate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | 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 | 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 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 | ⤷ 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 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: ⤷ Sign Up
Australia
Patent: 05233133
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0509191
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 61010
Estimated Expiration: ⤷ Sign Up
China
Patent: 38272
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 15
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 066911
Estimated Expiration: ⤷ Sign Up
El Salvador
Patent: 08002080
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 32890
Estimated Expiration: ⤷ Sign Up
Guatemala
Patent: 0500078
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 07532560
Estimated Expiration: ⤷ Sign Up
Patent: 09035535
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 065052
Estimated Expiration: ⤷ Sign Up
Panama
Patent: 29101
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 060676
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 06132180
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 1331
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 060135866
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 46105
Estimated Expiration: ⤷ Sign Up
Patent: 0606149
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 703
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Slovakia | 47297 | ESTROGENIC AGENTS, PHARMAUCEUTICAL COMPOSITION CONTAINING THEM AND THEIR USE | ⤷ Sign Up |
| Norway | 971815 | ⤷ Sign Up | |
| Russian Federation | 2006132180 | КРИСТАЛЛИЧЕСКИЙ ПОЛИМОРФ БАЗЕДОКСИФЕН АЦЕТАТА | ⤷ Sign Up |
| Australia | 710149 | ⤷ Sign Up | |
| China | 1170719 | ⤷ Sign Up | |
| >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 | ⤷ Sign Up | 300416, 20170415, EXPIRES: 20220414 |
| 0802183 | C00802183/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: BAZEDOXIFEN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58732 12.01.2010 |
| 0802183 | CA 2009 00035 | Denmark | ⤷ Sign Up | |
| 0802183 | PA2009007,C0802183 | Lithuania | ⤷ Sign Up | PRODUCT NAME: BAZEDOXIFENUM; REGISTRATION NO/DATE: EU/1/09/511/001 - EU/1/09/511/004 20090417 |
| 0802183 | 364 | Finland | ⤷ Sign Up | |
| >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.
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