FDA Orange Book
Generic for Axiron
Axiron contains testosterone. 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
Yes. The generic name for Axiron is testosterone. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
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Axiron products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, metered, transdermal | 30MG/1.5ML ACTUATION | Discontinued | None | 5 | AT |
NDA 022504, held by ELI LILLY AND CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic testosterone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 204255 | AT (A-rated, therapeutically equivalent) | February 28, 2017 | 30MG/1.5ML ACTUATION |
| ACTAVIS LABORATORIES UT INC | 205328 | AT (A-rated, therapeutically equivalent) | August 7, 2017 | 30MG/1.5ML ACTUATION |
| LUPIN LTD | 208061 | AT (A-rated, therapeutically equivalent) | October 23, 2017 | 30MG/1.5ML ACTUATION |
| CIPLA LTD | 209533 | AT (A-rated, therapeutically equivalent) | January 29, 2018 | 30MG/1.5ML ACTUATION |
| ENCUBE ETHICALS PRIVATE LTD | 212301 | AT (A-rated, therapeutically equivalent) | January 11, 2021 | 30MG/1.5ML ACTUATION |
Axiron patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9180194 | June 2, 2026 | Method of use | U-1390 | 022504 |
| 8993520 | June 2, 2026 | Method of use | U-1390 | 022504 |
| 8807861 | February 26, 2027 | Drug product | U-1563 | 022504 |
| 9289586 | February 26, 2027 | Method of use | U-1390 | 022504 |
| 8419307 | February 26, 2027 | Method of use | U-1386 | 022504 |
| 8435944 | September 27, 2027 | Method of use | U-1390 | 022504 |
Questions
Is there a generic for Axiron?
Yes. The generic name for Axiron is testosterone. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
What is the generic name for Axiron?
The active ingredient in Axiron is testosterone, per the FDA Orange Book.
When does the Axiron patent expire?
The last patent listed for Axiron in the Orange Book expires September 27, 2027. 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.