FDA Orange Book
Is there a generic for Natazia?
Natazia contains dienogest and estradiol valerate. 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 Natazia (dienogest and estradiol valerate). The Orange Book shows its last listed patent expires January 30, 2028.
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Natazia products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A | Marketed (Rx) | None | 0 | None |
NDA 022252, held by BAYER HEALTHCARE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Natazia patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8071577 | May 13, 2026 | Drug product | U-1 | 022252 |
| 8153616 | January 30, 2028 | Method of use | U-1240 | 022252 |
Questions
Is there a generic for Natazia?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Natazia (dienogest and estradiol valerate). The Orange Book shows its last listed patent expires January 30, 2028.
What is the generic name for Natazia?
The active ingredient in Natazia is dienogest and estradiol valerate, per the FDA Orange Book.
When does the Natazia patent expire?
The last patent listed for Natazia in the Orange Book expires January 30, 2028. 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.