Drug
Who makes testosterone undecanoate?
4 companies list testosterone undecanoate as a human prescription drug, including under the names Aveed, Jatenzo, Kyzatrex, Tlando. Forms: capsule, liquid filled; injection. Routes: intramuscular, oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing testosterone undecanoate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| TOLMAR Inc.United States | capsule, liquid filled | NDANDA206089 | 3 | 2 |
| Marius Pharmaceuticals | capsule, liquid filled | NDANDA213953 | 3 | 0 |
| Endo USA, Inc.United States | injection | NDANDA022219 | 1 | 3 |
| Verity Pharmaceuticals Inc. | capsule, liquid filled | NDANDA208088 | 1 | 0 |
Bulk ingredient listings
- ASG Biochem Private LimitedIndia · 1 NDC
- AX Pharmaceutical CorpCanada · 1 NDC
- Aspen Oss B.V.Netherlands · 1 NDC
- FIS FABBRICA ITALIANA SINTETICI SPAItaly · 1 NDC
- Hubei Zhuxi Humanwell Pharmaceutical Co. Ltd.China · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- MICRO-MACINAZIONE SASwitzerland · 1 NDC
- Pharma Source Direct, LLCUnited States · 1 NDC
- Pharmacia and Upjohn Company LLC · 1 NDC
- SHAKTI LIFESCIENCE PRIVATE LIMITEDIndia · 1 NDC
- Steroid S.p.A.Italy · 1 NDC
- Symbiotec Pharmalab LimitedIndia · 1 NDC
- Zhejiang Xianju Pharmaceutical Co., Ltd.China · 1 NDC
Orange Book patents
33 unexpired patents list testosterone undecanoate as the active ingredient, expiring between Jan 2027 and Apr 2041. Application holders: ENDO OPERATIONS LTD, MARIUS PHARMACEUTICALS INC, TOLMAR INC, VERITY PHARMACEUTICALS INC.
Enquiry
Common questions
- Who makes testosterone undecanoate?
- 4 companies list testosterone undecanoate as a human prescription drug in the openFDA NDC Directory, led by TOLMAR Inc., Marius Pharmaceuticals, Endo USA, Inc., Verity Pharmaceuticals Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Who supplies testosterone undecanoate active ingredient?
- 13 companies list testosterone undecanoate as a bulk ingredient, including ASG Biochem Private Limited, AX Pharmaceutical Corp, Aspen Oss B.V., FIS FABBRICA ITALIANA SINTETICI SPA.