Prescription medicine

Bazedoxifene and estrogens conjugated Brand names: Duavee

Bazedoxifene and estrogens conjugated (Duavee) is a prescription medicine with an FDA approval on record since 2013. No generic is listed; pharmacies paid $6.48 per Duavee 0.45-20 mg tablet in the October 7, 2026 NADAC survey.

No generic listed
Boxed warning

Check it at the source: the bazedoxifene and estrogens conjugated FDA label on DailyMed (effective April 28, 2026, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.); the NDA 22247 record on Drugs@FDA; every bazedoxifene and estrogens conjugated label on DailyMed.

Highlights of the record

FDA label of April 28, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Boxed warning

ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, AND PROBABLE DEMENTIA •.

Women taking DUAVEE should not take additional estrogens [see Warnings and Precautions (5.1) ]

There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. DUAVEE has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding [see Warnings and Precautions (5.3) ]

Estrogen therapy should not be used for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.2 , 5.4) ]

The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (0.625 mg)-alone, relative to placebo [see Warnings and Precautions (5.2) ]

The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older during 5.2 years of treatment with daily conjugated estrogens (0.625 mg)-alone, relative to placebo. […]

Used for

From the label: indications and usage
DUAVEE is indicated in women with a uterus for: DUAVEE is a combination of conjugated estrogens with an estrogen agonist/antagonist indicated for treatment of the following conditions in women with a uterus:
Treatment of moderate to severe vasomotor symptoms associated with menopause ( 1.1 )
Prevention of postmenopausal osteoporosis ( 1.2 ) Limitation of Use: DUAVEE should be used for the shortest duration consis

Forms and strengths

0.45 mg / 20 mg

Film-coated tablet.

On the market

Earliest approval on file: October 3, 2013 Duavee, Wyeth Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 2 of which 0 under generic applications, 2 under brand applications, repackagers included
Last listed patent: March 10, 2027 Duavee tablets; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): $6.48 per tablet Duavee 0.45-20 mg tablet
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 932 through July 30, 2026

What is bazedoxifene and estrogens conjugated used for?

From the label: indications and usage
DUAVEE is indicated in women with a uterus for: DUAVEE is a combination of conjugated estrogens with an estrogen agonist/antagonist indicated for treatment of the following conditions in women with a uterus:
Treatment of moderate to severe vasomotor symptoms associated with menopause ( 1.1 )
Prevention of postmenopausal osteoporosis ( 1.2 ) Limitation of Use: DUAVEE should be used for the shortest duration consistent with treatment goals and risks for the individual woman ( 1.3 ) 1.1 Treatment of Moderate to Severe Vasomotor Symptoms Associated with Menopause 1.2 Prevention of Postmenopausal Osteoporosis 1.3 Important Limitations of Use
Use DUAVEE for the shortest duration consistent with treatment goals and risks for the individual woman. […]

Conditions named in the indications of bazedoxifene and estrogens conjugated's FDA labels, with every medicine labeled for each:

Osteoporosis

FDA pharmacologic class: Estrogen and Estrogen Agonist/Antagonist.

Source: FDA drug label (Duavee), Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., effective April 28, 2026 (SPL set e1b75458-2e5b-46b9-92c6-fa6daba3770f), via openFDA; the full label on DailyMed

What does the patient leaflet for bazedoxifene and estrogens conjugated say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about DUAVEE?
Do not take additional estrogen products while you are taking DUAVEE. • Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). • Report any unusual vaginal bleeding right away while you are taking DUAVEE. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. • Do not use estrogens to prevent heart disease, heart attacks, strokes or dementia (decline in brain function). • Using estrogen-alone may increase your chances of getting strokes or blood clots. • Using estrogen-alone may increase your chances of getting dementia, based on a study of women 65 years of age or older. • The risks listed above are based on a study of an estrogen-alone oral product. Since other products and doses have not been studied in the same way, it is not known how the use of DUAVEE will affect your chances of getting these conditions. You and your healthcare provider should talk regularly about whether you still need treatment with DUAVEE.

Is there a generic for bazedoxifene and estrogens conjugated (Duavee)?

No generic bazedoxifene and estrogens conjugated is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 1 patent for Duavee tablets: the compound patent runs to March 10, 2027. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2013 earliest approval on file
2027 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for bazedoxifene and estrogens conjugated (Duavee)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $6.48 per Duavee 0.45-20 mg tablet, about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

Duavee 0.45-20 mg tablet (brand)

$6.50

$6.28

January 2024October 2026

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
Duavee 0.45-20 mg tablet	Brand	$6.48 per tablet	$194.38	-0.1%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

What does the bazedoxifene and estrogens conjugated label say about other medicines?

The bazedoxifene and estrogens conjugated label names 8 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Atorvastatin	drug interactions	Concomitant administration of bazedoxifene (40 mg daily) and atorvastatin (20 mg, single-dose) to healthy postmenopausal women did not affect the pharmacokinetics of bazedoxifene, atorvastatin or its active metabolites.
Carbamazepine	drug interactions	Inducers of CYP3A4, such as St. John's Wort (Hypericum perforatum) preparations, phenobarbital, carbamazepine, and rifampin, may reduce plasma concentrations of some estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile.
Estradiol	warnings and precautions	Free hormone concentrations, such as testosterone and estradiol, may be decreased.
Itraconazole	drug interactions	Concomitant administration of itraconazole, a strong CYP3A4 inhibitor, with DUAVEE, resulted in increases in bazedoxifene exposure (40%) and, to a lesser extent, conjugated estrogens exposure (9% for baseline-adjusted total estrone, 5% for total equilin), compared to DUAVEE alone [see Pharmacokinetics (12.3) ].
Phenobarbital	drug interactions	Inducers of CYP3A4, such as St. John's Wort (Hypericum perforatum) preparations, phenobarbital, carbamazepine, and rifampin, may reduce plasma concentrations of some estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile.
Phenytoin	drug interactions	The metabolism of bazedoxifene may be increased by concomitant use of substances known to induce UGTs, such as rifampin, phenobarbital, carbamazepine, and phenytoin.
Rifampin	drug interactions	Inducers of CYP3A4, such as St. John's Wort (Hypericum perforatum) preparations, phenobarbital, carbamazepine, and rifampin, may reduce plasma concentrations of some estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile.
Testosterone	warnings and precautions	Free hormone concentrations, such as testosterone and estradiol, may be decreased.

Check bazedoxifene and estrogens conjugated against other medicines

What do FAERS reports show for bazedoxifene and estrogens conjugated?

The FDA Adverse Event Reporting System holds 932 reports that list bazedoxifene and estrogens conjugated among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 34 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

Drug Ineffective (a use or a product term, not a reaction)140
Hot Flush (named in the label)78
Nausea (named in the label)42
Muscle Spasms (named in the label)41
Off Label Use (a use or a product term, not a reaction)39
Weight Increased35
Feeling Abnormal33
Headache (named in the label)33

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as bazedoxifene and estrogens conjugated?

8 other medicines are given the same way (oral) and in the same FDA class as bazedoxifene and estrogens conjugated or labeled mainly for the same use (osteoporosis), the same class first. Osteoporosis lists all 16 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (oral)	Pharmacy cost	Shortage
Estradiol	Osteoporosis	21 labelers	$0.0635 per tablet 1 mg tablet	No current entry
Ethinyl estradiol and norethindrone	Osteoporosis	15 labelers	$0.181 per tablet 21 1-20 tablet	No current entry
Raloxifene	Osteoporosis	17 labelers	$0.223 per tablet 60 mg tablet	No current entry
Estradiol and norethindrone	Osteoporosis	7 labelers	$0.802 per tablet 0.5-0.1 mg tablet	No current entry
Alendronate	Osteoporosis	16 labelers	$0.256 per tablet 70 mg tablet	No current entry
Risedronate	Osteoporosis	8 labelers	$12.91 per tablet 150 mg tablet	No current entry
Ibandronate	Osteoporosis	6 labelers	$2.68 per tablet 150 mg tablet	No current entry
Alendronate and cholecalciferol	Osteoporosis	none listed	$52.51 per unit 70 mg-5600 unit	No current entry

Every medicine labeled for the same conditions as bazedoxifene and estrogens conjugated

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to bazedoxifene and estrogens conjugated: 8 medicines for the same use
Other estrogens: the pharmacologic class, with prices and generics
Bazedoxifene and estrogens conjugated side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other