BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED | N022247 | WYETH PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Diamond Research Foundation FDA-2026-P-1450 · 4 docket documents Beth Rosenshein of the Diamond Research Foundation requests that the FDA update Section 5.2 of the Full Prescribing Information for Duavee tablets (conjugated estrogens/bazedoxifene) to include information about the increased risk of venous thromboembolism when using the combination of the selective | Other | 2026-02-09 | Open | Diamond Research Foundation |
Citizen Petition from Diamond Research Foundation FDA-2025-P-6074 · 5 docket documents Beth Rosenshein of the Diamond Research Foundation submitted this petition requesting that the FDA revise the INDICATIONS AND USAGE section of the prescribing label for Premarin tablets at 0.30 mg and 0.45 mg dosages to remove the indication for treatment of hypoestrogenism due to hypogonadism, cast | Other | 2025-11-13 | Open | Diamond Research Foundation |
Citizen Petition from Ropes & Gray LLP (Pfizer Inc.) FDA-2016-P-3082 · 26 docket documents Pfizer Inc., through counsel at Ropes & Gray LLP, filed this citizen petition under section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA recognize 5-year exclusivity under sections 505(c)(3)(E)(ii) and 505(j)(5)(F)(ii) for bazedoxifene, the new active moiety in DUAVEE (con | Other | 2016-10-04 | Granted | Ropes & Gray LLP (Pfizer Inc.) |
Citizen Petition from Pfizer Inc (Ropes and Gray LLP) FDA-2014-P-0737 · 3 docket documents Pfizer Inc filed this citizen petition under section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA recognize five-year exclusivity under sections 505(c)(3)(E)(ii) and 505(j)(5)(F)(ii) for bazedoxifene, the new active moiety in DUAVEE, a fixed-dose combination of conjugated | Other | 2014-07-09 | Denied | Pfizer Inc (Ropes and Gray LLP) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$6.48
per ea
Lowest NADAC/Unit
$6.48
per ea
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00008112312DUAVEE 0.45-20 MG TABLET | $6.48 | EA | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7683051 | Mar 10, 2027 | — | Yes | Yes | — |