FDA Orange Book
Generic for Androgel
Androgel 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 Androgel is testosterone. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AB1, AB2.
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Androgel products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, metered, transdermal | 1.62% (20.25MG/1.25GM ACTUATION) | Marketed (Rx) | AB | 6 | AB |
| gel, metered, transdermal | 12.5MG/1.25GM ACTUATION | Marketed (Rx) | AB1 | 2 | AB1 |
| gel, transdermal | 1.62% (20.25MG/1.25GM PACKET) | Marketed (Rx) | AB2 | 2 | AB2 |
| gel, transdermal | 1.62% (40.5MG/2.5GM PACKET) | Marketed (Rx) | AB2 | 2 | AB2 |
| gel, transdermal | 25MG/2.5GM PACKET | Marketed (Rx) | AB1 | 3 | AB1 |
| gel, transdermal | 50MG/5GM PACKET | Marketed (Rx) | AB1 | 4 | AB1, AB2 |
NDA 022309, 021015, held by BESINS HEALTHCARE IRELAND LTD. 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 |
|---|---|---|---|---|
| STRIDES PHARMA INTERNATIONAL AG | 076744 | AB1 (A-rated, therapeutically equivalent) | May 23, 2007 | 25MG/2.5GM PACKET, 50MG/5GM PACKET |
| ACTAVIS LABORATORIES UT INC | 076737 | AB1 (A-rated, therapeutically equivalent) | March 9, 2015 | 12.5MG/1.25GM ACTUATION, 25MG/2.5GM PACKET, 50MG/5GM PACKET |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 204268 | AB (A-rated, therapeutically equivalent) | August 4, 2015 | 1.62% (20.25MG/1.25GM ACTUATION) |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 205781 | AB2 (A-rated, therapeutically equivalent) | July 12, 2017 | 1.62% (20.25MG/1.25GM PACKET), 1.62% (40.5MG/2.5GM PACKET) |
| ACTAVIS LABORATORIES UT INC | 091073 | AB2 (A-rated, therapeutically equivalent) | September 18, 2017 | 50MG/5GM PACKET |
| ACTAVIS LABORATORIES UT INC | 204570 | AB (A-rated, therapeutically equivalent) | April 10, 2019 | 1.62% (20.25MG/1.25GM ACTUATION), 1.62% (20.25MG/1.25GM PACKET), 1.62% (40.5MG/2.5GM PACKET) |
| AMNEAL PHARMACEUTICALS LLC | 207373 | AB (A-rated, therapeutically equivalent) | April 10, 2019 | 1.62% (20.25MG/1.25GM ACTUATION) |
| ENCUBE ETHICALS PRIVATE LTD | 208620 | AB (A-rated, therapeutically equivalent) | April 10, 2019 | 1.62% (20.25MG/1.25GM ACTUATION) |
| LUPIN INC | 208560 | AB (A-rated, therapeutically equivalent) | April 10, 2019 | 1.62% (20.25MG/1.25GM ACTUATION) |
| XIROMED PHARMA ESPANA SL | 210835 | AB (A-rated, therapeutically equivalent) | April 16, 2020 | 1.62% (20.25MG/1.25GM ACTUATION) |
| ENCUBE ETHICALS PRIVATE LTD | 212984 | AB1 (A-rated, therapeutically equivalent) | February 9, 2024 | 12.5MG/1.25GM ACTUATION, 25MG/2.5GM PACKET, 50MG/5GM PACKET |
Androgel patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8466138 | October 12, 2026 | Method of use | U-1103 | 022309 |
| 8466137 | October 12, 2026 | Method of use | U-1103 | 022309 |
| 8741881 | October 12, 2026 | Method of use | U-1103 | 022309 |
| 8729057 | October 12, 2026 | Drug product | None | 022309 |
| 8759329 | October 12, 2026 | Drug product | None | 022309 |
| 8754070 | October 12, 2026 | Drug product | None | 022309 |
| 8466136 | October 12, 2026 | Drug product | None | 022309 |
| 8486925 | October 12, 2026 | Drug product | None | 022309 |
Androgel NDC codes
Questions
Is there a generic for Androgel?
Yes. The generic name for Androgel is testosterone. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AB1, AB2.
What is the generic name for Androgel?
The active ingredient in Androgel is testosterone, per the FDA Orange Book.
When does the Androgel patent expire?
The last patent listed for Androgel in the Orange Book expires October 12, 2026. 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.