FDA Orange Book
Is there a generic for Xyosted (autoinjector)?
Xyosted (autoinjector) contains testosterone enanthate. 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 Xyosted (autoinjector) (testosterone enanthate). The Orange Book shows its last listed patent expires September 4, 2036.
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Xyosted (autoinjector) products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | 100MG/0.5ML (100MG/0.5ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 50MG/0.5ML (50MG/0.5ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 75MG/0.5ML (75MG/0.5ML) | Marketed (Rx) | None | 0 | None |
NDA 209863, held by ANTARES PHARMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Xyosted (autoinjector) patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11446441 | January 24, 2026 | Drug product | None | 209863 |
| 9533102 | January 24, 2026 | Drug product | None | 209863 |
| 9180259 | January 24, 2026 | Drug product | None | 209863 |
| 9629959 | January 24, 2026 | Drug product | None | 209863 |
| 10478560 | January 24, 2026 | Drug product | None | 209863 |
| 8562564 | January 24, 2026 | Drug product | None | 209863 |
| 8021335 | October 4, 2026 | Drug product | None | 209863 |
| 11497753 | March 19, 2030 | Drug product | None | 209863 |
| 10279131 | July 31, 2031 | Drug product | None | 209863 |
| 10357609 | August 21, 2031 | Drug product | None | 209863 |
| 10905827 | August 21, 2031 | Drug product | None | 209863 |
| 11446440 | August 21, 2031 | Drug product | None | 209863 |
| 11844804 | June 4, 2033 | Method of use | U-2418 | 209863 |
| 10821072 | June 4, 2033 | Drug product | U-2418 | 209863 |
| 10881798 | February 11, 2034 | Drug product | None | 209863 |
| 11160751 | October 7, 2034 | Drug product | U-2418 | 209863 |
| 10912782 | February 19, 2035 | Drug product | U-2418 | 209863 |
| 10238662 | February 19, 2035 | Drug product | U-2418 | 209863 |
| 11813435 | February 25, 2035 | Drug product | None | 209863 |
| 12629483 | August 7, 2035 | Drug product | None | 209863 |
| 11191908 | October 18, 2035 | Drug product | None | 209863 |
| 9744302 | November 19, 2035 | Drug product | None | 209863 |
| 9950125 | September 4, 2036 | Drug product | U-2418 | 209863 |
Xyosted (autoinjector) NDC codes
Questions
Is there a generic for Xyosted (autoinjector)?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xyosted (autoinjector) (testosterone enanthate). The Orange Book shows its last listed patent expires September 4, 2036.
What is the generic name for Xyosted (autoinjector)?
The active ingredient in Xyosted (autoinjector) is testosterone enanthate, per the FDA Orange Book.
When does the Xyosted (autoinjector) patent expire?
The last patent listed for Xyosted (autoinjector) in the Orange Book expires September 4, 2036. 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.