Generic competition · all medicines · read 12 November 2026
Is there a generic of Testosterone, and who makes it?
Testosterone appears in 8 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 10 generic makers listed as marketed across them. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. Where both are dated, the first generic approval came between 5.9 and 11.4 years after the first brand approval. This is the Orange Book's listing, not a forecast.
Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.
- Testosterone appears in 8 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 10 generic makers listed as marketed across them.
- 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
- Where both are dated, the first generic approval came between 5.9 and 11.4 years after the first brand approval.
- Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.
Gel, Transdermal
Four or more generic makers listed
Brand listed as marketed: Androgel, Testim and Vogelxo. 4 generic makers with 11 generic products listed as marketed; the first generic approval is dated 27 January 2006.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Actavis Laboratories Ut Inc | 27 January 2006 | 5 |
| Strides Pharma International Ag | 23 May 2007 | 2 |
| Padagis Israel Pharmaceuticals Ltd | 12 July 2017 | 2 |
| Encube Ethicals Private Ltd | 9 November 2021 | 2 |
Patents and exclusivities still listed
- 11 February 2034Patent 8785426 drug product
- 11 February 2034Patent 9662340 drug product
- 11 February 2034Patent 9295675 drug product
Gel, Metered, Transdermal
Four or more generic makers listed
Brand listed as marketed: Androgel and Vogelxo. 7 generic makers with 9 generic products listed as marketed; the first generic approval is dated 9 March 2015.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Actavis Laboratories Ut Inc | 9 March 2015 | 2 |
| Padagis Israel Pharmaceuticals Ltd | 4 August 2015 | 1 |
| Actavis Laboratories Ut Inc Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc | 5 August 2015 | 1 |
| Amneal Pharmaceuticals Llc | 10 April 2019 | 1 |
| Encube Ethicals Private Ltd | 10 April 2019 | 2 |
| Lupin Inc | 10 April 2019 | 1 |
| Xiromed Pharma Espana Sl | 16 April 2020 | 1 |
Patents and exclusivities still listed
- 11 February 2034Patent 8785426 drug product
- 11 February 2034Patent 9662340 drug product
- 11 February 2034Patent 9295675 drug product
Solution, Metered, Transdermal
Four or more generic makers listed
Every brand product here is listed as discontinued. 5 generic makers with 5 generic products listed as marketed; the first generic approval is dated 28 February 2017.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Padagis Israel Pharmaceuticals Ltd | 28 February 2017 | 1 |
| Actavis Laboratories Ut Inc | 7 August 2017 | 1 |
| Lupin Ltd | 23 October 2017 | 1 |
| Cipla Ltd | 29 January 2018 | 1 |
| Encube Ethicals Private Ltd | 11 January 2021 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Film, Extended Release, Transdermal
Nothing listed as marketed
Every brand product here is listed as discontinued. No generic is listed as marketed.
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Injectable, Injection
Nothing listed as marketed
No brand application is listed. No generic is listed as marketed (3 generic products listed as discontinued).
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Gel, Metered, Nasal
Brand listed, no generic listed as marketed
Brand listed as marketed: Natesto. No generic is listed as marketed.
Patents and exclusivities still listed
- 17 March 2034Patent 11744838
- 17 March 2034Patent 11090312
Pellet, Implantation
Generics listed, no brand listed
No brand application is listed. 1 generic maker with 1 generic product listed as marketed.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Endo Operations Ltd | not dated | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Tablet, Extended Release, Buccal
Nothing listed as marketed
Every brand product here is listed as discontinued. No generic is listed as marketed.
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.
Where can you go from this result?
Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.