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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 022247


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NDA 022247 describes DUAVEE, which is a drug marketed by Wyeth Pharms and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the DUAVEE profile page.

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.
Summary for 022247
Tradename:DUAVEE
Applicant:Wyeth Pharms
Ingredient:bazedoxifene acetate; estrogens, conjugated
Patents:2
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022247
Generic Entry Date for 022247*:
Constraining patent/regulatory exclusivity:
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.

Pharmacology for NDA: 022247
Suppliers and Packaging for NDA: 022247
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DUAVEE bazedoxifene acetate; estrogens, conjugated TABLET;ORAL 022247 NDA Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 0008-1123 0008-1123-12 1 POUCH in 1 CARTON (0008-1123-12) / 2 BLISTER PACK in 1 POUCH / 15 TABLET, FILM COATED in 1 BLISTER PACK
DUAVEE bazedoxifene acetate; estrogens, conjugated TABLET;ORAL 022247 NDA U.S. Pharmaceuticals 63539-122 63539-122-07 1 BLISTER PACK in 1 CARTON (63539-122-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE;0.45MG
Approval Date:Oct 3, 2013TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:May 6, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
Patent:⤷  Sign UpPatent Expiration:May 6, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
Patent:⤷  Sign UpPatent Expiration:Mar 10, 2027Product Flag?YSubstance Flag?YDelist Request?
Patented Use:PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS

Expired US Patents for NDA 022247

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

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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.