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.
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: | ⤷ Try a Trial | Patent Expiration: | May 6, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS | ||||||||
| Patent: | ⤷ Try a Trial | 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: | ⤷ Try a Trial | 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 | ⤷ 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 |
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