FDA Orange Book
Is there a generic for Bijuva?
Bijuva contains estradiol and progesterone. 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 Bijuva (estradiol and progesterone). The Orange Book shows its last listed patent expires November 21, 2032.
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Bijuva products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 0.5MG;100MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 1MG;100MG | Marketed (Rx) | None | 0 | None |
NDA 210132, held by MAYNE PHARMA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Bijuva patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11793819 | November 21, 2032 | Method of use | U-2439 | 210132 |
| 11033626 | November 21, 2032 | Drug product | U-2439 | 210132 |
| 10206932 | November 21, 2032 | Method of use | U-2439 | 210132 |
| 9301920 | November 21, 2032 | Drug product | U-2439 | 210132 |
| 9114146 | November 21, 2032 | Drug product | U-2439 | 210132 |
| 9114145 | November 21, 2032 | Method of use | U-2439 | 210132 |
| 8933059 | November 21, 2032 | Drug product | U-2439 | 210132 |
| 8846649 | November 21, 2032 | Drug product | U-2439 | 210132 |
| 8846648 | November 21, 2032 | Method of use | U-2439 | 210132 |
| 10675288 | November 21, 2032 | Method of use | U-2439 | 210132 |
| 8987237 | November 21, 2032 | Drug product | None | 210132 |
| 11166963 | November 21, 2032 | Drug product | None | 210132 |
| 8993549 | November 21, 2032 | Drug product | None | 210132 |
| 8633178 | November 21, 2032 | Drug product | None | 210132 |
| 10052386 | November 21, 2032 | Drug product | None | 210132 |
| 11865179 | November 21, 2032 | Drug substance, Drug product | None | 210132 |
| 8993548 | November 21, 2032 | Drug product | None | 210132 |
| 9006222 | November 21, 2032 | Drug product | U-2439 | 210132 |
| 10806740 | November 21, 2032 | Drug product | U-2439 | 210132 |
| 11103513 | November 21, 2032 | Method of use | U-2439 | 210132 |
| 11529360 | November 21, 2032 | Drug product | None | 210132 |
| 10639375 | November 21, 2032 | Drug product | None | 210132 |
| 11110099 | November 21, 2032 | Drug product | None | 210132 |
| 11103516 | November 21, 2032 | Drug product | None | 210132 |
Questions
Is there a generic for Bijuva?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Bijuva (estradiol and progesterone). The Orange Book shows its last listed patent expires November 21, 2032.
What is the generic name for Bijuva?
The active ingredient in Bijuva is estradiol and progesterone, per the FDA Orange Book.
When does the Bijuva patent expire?
The last patent listed for Bijuva in the Orange Book expires November 21, 2032. 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.