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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

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

Drug patent expirations by year for DUAVEE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DUAVEE

Generic Entry Date for DUAVEE^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial NDA: 022247 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

See all DUAVEE clinical trials

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

G03XC	Selective estrogen receptor modulators
G03X	OTHER SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

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

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Glossary

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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

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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

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

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Country	Patent Number	Title	Estimated Expiration
Germany	122009000061		⤷ Try a Trial
China	1106383		⤷ Try a Trial
Spain	2162198		⤷ Try a Trial
Israel	120701		⤷ Try a Trial
Hungary	227077	ESTROGENICAL 2-PHENYL-1-BENZYL-INDOLE DERIVATIVES, PREPARATION AND USE THEREOF AND PHARMACEUTICAL COMPOSITIONS CONTAINING THESE COMPOUNDS	⤷ Try a Trial
Japan	H1036346	ESTROGEN AGENT	⤷ Try a Trial
South Korea	20060135866	CRYSTALLINE POLYMORPH OF A BAZEDOXIFENE ACETATE	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for DUAVEE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0802183	CA 2009 00035	Denmark	⤷ Try a Trial
0802183	300416	Netherlands	⤷ Try a Trial	300416, 20170415, EXPIRES: 20220414
0802183	2009/028	Ireland	⤷ Try a Trial	PRODUCT NAME: BAZEDOXIFENE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/09/511/001-004 20090417
0802183	PA2009007,C0802183	Lithuania	⤷ Try a Trial	PRODUCT NAME: BAZEDOXIFENUM; REGISTRATION NO/DATE: EU/1/09/511/001 - EU/1/09/511/004 20090417
0802183	C00802183/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: BAZEDOXIFEN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58732 12.01.2010
0802183	SPC/GB09/045	United Kingdom	⤷ Try a 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	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