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DUAVEE Drug Profile
» See Plans and Pricing
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
Summary for DUAVEE
| International Patents: | 23 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 8 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for DUAVEE |
| DailyMed Link: | DUAVEE at DailyMed |
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
| Sponsor | Phase |
|---|---|
| Carol Fabian, MD | Early Phase 1 |
| Breast Cancer Research Foundation | Early Phase 1 |
| Foundation of Hope, North Carolina | Phase 4 |
Pharmacology for DUAVEE
| Drug Class | Estrogen Estrogen Agonist/Antagonist |
| Mechanism of Action | Estrogen Receptor Agonists Selective Estrogen Receptor Modulators |
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 |
International Patents for DUAVEE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 4093611 | Start Trial |
| Singapore | 151331 | Start Trial |
| Costa Rica | 8615 | Start Trial |
| Portugal | 802183 | Start Trial |
| Israel | 178236 | Start Trial |
| Canada | 2203079 | Start Trial |
| Eurasian Patent Organization | 001448 | Start Trial |
| >Country | >Patent Number | >Estimated 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 |
