FDA Orange Book
Is there a generic for Kyzatrex?
Kyzatrex contains testosterone undecanoate. 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 Kyzatrex (testosterone undecanoate). The Orange Book shows its last listed patent expires March 29, 2041.
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Kyzatrex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Discontinued | None | 0 | None |
| capsule, oral | 150MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 200MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 50MG | Marketed (Rx) | None | 0 | None |
NDA 213953, held by MARIUS PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Kyzatrex patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10576089 | December 31, 2030 | Drug product | U-2506 | 213953 |
| 10576090 | December 31, 2030 | Drug product | None | 213953 |
| 11590146 | December 31, 2030 | Drug product | None | 213953 |
| 11617758 | March 15, 2033 | Drug product | U-2506 | 213953 |
| 12357643 | March 15, 2033 | Drug product | U-2506 | 213953 |
| 12403146 | March 29, 2041 | Drug product | U-2506 | 213953 |
Kyzatrex NDC codes
Questions
Is there a generic for Kyzatrex?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Kyzatrex (testosterone undecanoate). The Orange Book shows its last listed patent expires March 29, 2041.
What is the generic name for Kyzatrex?
The active ingredient in Kyzatrex is testosterone undecanoate, per the FDA Orange Book.
When does the Kyzatrex patent expire?
The last patent listed for Kyzatrex in the Orange Book expires March 29, 2041. 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.
More on Kyzatrex and Testosterone Undecanoate
- What is Kyzatrex used for?FDA label uses
- Is Kyzatrex a controlled substance?Schedule III
- Is Testosterone Undecanoate a controlled substance?Schedule III
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- Androgens listFDA drug class
- NDC 80603-103Kyzatrex NDC record
- NDC 80603-105Kyzatrex NDC record
- NDC 80603-107Kyzatrex NDC record
- Schedule III drugs listDEA schedule