FDA Orange Book
Is there a generic for Duavee?
Duavee contains estrogens conjugated and bazedoxifene acetate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Duavee (estrogens conjugated and bazedoxifene acetate). The Orange Book shows its last listed patent expires March 10, 2027.
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Duavee products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 20MG BASE;0.45MG | Marketed (Rx) | None | 0 | None |
NDA 022247, held by WYETH PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Duavee patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7683051 | March 10, 2027 | Drug substance, Drug product | U-594 | 022247 |
| 7683051 | March 10, 2027 | Drug substance, Drug product | U-904 | 022247 |
Duavee NDC codes
Questions
Is there a generic for Duavee?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Duavee (estrogens conjugated and bazedoxifene acetate). The Orange Book shows its last listed patent expires March 10, 2027.
What is the generic name for Duavee?
The active ingredient in Duavee is estrogens conjugated and bazedoxifene acetate, per the FDA Orange Book.
When does the Duavee patent expire?
The last patent listed for Duavee in the Orange Book expires March 10, 2027. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.