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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Questions you can ask:
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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 |
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 |
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 |
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
See the table below for patents covering DUAVEE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Ecuador | SP066911 | POLIMORFO CRISTALINO DE UN ACETATO DE BAZEDOXIFENO | ⤷ Sign Up |
Luxembourg | 91608 | ⤷ Sign Up | |
Ukraine | 85703 | КРИСТАЛІЧНИЙ ПОЛІМОРФ БАЗЕДОКСИФЕНУ АЦЕТАТУ[КРИСТАЛЛИЧЕСКИЙ ПОЛИМОРФ БАЗЕДОКСИФЕНА АЦЕТАТА (CRYSTALLINE POLYMORPH OF BAZEDOXIFENE ACETATE) | ⤷ Sign Up |
Slovenia | 802183 | ⤷ Sign Up | |
South Korea | 20060135866 | CRYSTALLINE POLYMORPH OF A BAZEDOXIFENE ACETATE | ⤷ Sign Up |
European Patent Office | 0802183 | Composés oestrogènes (Estrogenic agents) | ⤷ Sign Up |
Norway | 2009025 | ⤷ 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 | SPC/GB09/045 | United Kingdom | ⤷ Sign Up | 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 | Lithuania | ⤷ Sign Up | PRODUCT NAME: BAZEDOXIFENUM; REGISTRATION NO/DATE: EU/1/09/511/001 - EU/1/09/511/004 20090417 |
0802183 | PA2009007,C0802183 | Lithuania | ⤷ Sign Up | PRODUCT NAME: BAZEDOXIFENUM; REGISTRATION NO/DATE: EU/1/09/511/001 - EU/1/09/511/004 20090417 |
0802183 | 300416 | Netherlands | ⤷ Sign Up | 300416, 20170415, EXPIRES: 20220414 |
0802183 | 364 | Finland | ⤷ Sign Up | |
0802183 | 91608 | Luxembourg | ⤷ Sign Up | 91608, EXPIRES: 20220415 |
0802183 | 2009/028 | Ireland | ⤷ Sign Up | PRODUCT NAME: BAZEDOXIFENE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/09/511/001-004 20090417 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |