FDA Orange Book
Is there a generic for Tlando?
Tlando 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 Tlando (testosterone undecanoate). The Orange Book shows its last listed patent expires April 28, 2041.
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Tlando products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 112.5MG | Marketed (Rx) | None | 0 | None |
NDA 208088, held by VERITY PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tlando patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11304960 | January 8, 2029 | Drug product | U-1500 | 208088 |
| 8865695 | January 8, 2029 | Method of use | U-1500 | 208088 |
| 8778922 | January 8, 2029 | Drug product | U-1500 | 208088 |
| 11433083 | November 30, 2030 | Method of use | U-1500 | 208088 |
| 11364249 | November 30, 2030 | Method of use | U-1500 | 208088 |
| 10716794 | November 30, 2030 | Method of use | U-1500 | 208088 |
| 9949985 | November 30, 2030 | Method of use | U-1500 | 208088 |
| 11311555 | November 30, 2030 | Method of use | U-1500 | 208088 |
| 10226473 | November 30, 2030 | Method of use | U-1500 | 208088 |
| 9943527 | November 30, 2030 | Method of use | U-1500 | 208088 |
| 11559530 | November 28, 2037 | Method of use | U-1500 | 208088 |
| 12310978 | February 21, 2039 | Method of use | U-4194 | 208088 |
| 12011503 | October 16, 2040 | Drug product | U-3964 | 208088 |
| 12011503 | October 16, 2040 | Drug product | U-3965 | 208088 |
| 11464735 | April 28, 2041 | Drug product | U-1500 | 208088 |
| 12691057 | April 28, 2041 | Drug product | U-4194 | 208088 |
Tlando NDC codes
Questions
Is there a generic for Tlando?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tlando (testosterone undecanoate). The Orange Book shows its last listed patent expires April 28, 2041.
What is the generic name for Tlando?
The active ingredient in Tlando is testosterone undecanoate, per the FDA Orange Book.
When does the Tlando patent expire?
The last patent listed for Tlando in the Orange Book expires April 28, 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 Tlando and Testosterone Undecanoate
- What is Tlando used for?FDA label uses
- Is Tlando a controlled substance?Schedule III
- Is Testosterone Undecanoate a controlled substance?Schedule III
- Generic for JatenzoFDA Orange Book
- Generic for KyzatrexFDA Orange Book
- Generic for AveedFDA Orange Book
- Androgens listFDA drug class
- NDC 74676-0112Tlando NDC record
- Schedule III drugs listDEA schedule