FDA Orange Book
Is there a generic for Jatenzo?
Jatenzo 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 Jatenzo (testosterone undecanoate). The Orange Book shows its last listed patent expires April 12, 2039.
Run it in Rivvi
Map Jatenzo and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Jatenzo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 158MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 198MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 237MG | Marketed (Rx) | None | 0 | None |
NDA 206089, held by TOLMAR INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Jatenzo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11179402 | April 14, 2026 | Drug substance, Drug product | None | 206089 |
| 11331325 | January 6, 2027 | Method of use | U-2506 | 206089 |
| 8241664 | March 29, 2029 | Drug product | U-2506 | 206089 |
| 10543219 | April 12, 2030 | Method of use | U-2506 | 206089 |
| 11179403 | April 12, 2030 | Method of use | U-2506 | 206089 |
| 11426416 | April 12, 2030 | Method of use | U-3420 | 206089 |
| 10617696 | April 12, 2030 | Drug substance, Drug product | None | 206089 |
| 8778916 | April 12, 2030 | Drug product | None | 206089 |
| 8492369 | December 20, 2030 | Drug product | U-2506 | 206089 |
| 11564933 | April 12, 2039 | Method of use | U-1103 | 206089 |
| 12605391 | April 12, 2039 | Method of use | U-1103 | 206089 |
Jatenzo NDC codes
Questions
Is there a generic for Jatenzo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Jatenzo (testosterone undecanoate). The Orange Book shows its last listed patent expires April 12, 2039.
What is the generic name for Jatenzo?
The active ingredient in Jatenzo is testosterone undecanoate, per the FDA Orange Book.
When does the Jatenzo patent expire?
The last patent listed for Jatenzo in the Orange Book expires April 12, 2039. 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 Jatenzo and Testosterone Undecanoate
- What is Jatenzo used for?FDA label uses
- Is Jatenzo a controlled substance?Schedule III
- Is Testosterone Undecanoate a controlled substance?Schedule III
- Generic for KyzatrexFDA Orange Book
- Generic for TlandoFDA Orange Book
- Generic for AveedFDA Orange Book
- Androgens listFDA drug class
- NDC 69087-158Jatenzo NDC record
- NDC 69087-198Jatenzo NDC record
- NDC 69087-237Jatenzo NDC record
- Schedule III drugs listDEA schedule