Details for New Drug Application (NDA): 022247
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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
Mechanism of Action | Estrogen Receptor Agonists Selective Estrogen Receptor Modulators |
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: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE;0.45MG | ||||
Approval Date: | Oct 3, 2013 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 6, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 6, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 10, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist 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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