testosterone undecanoate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| androgens/anabolic steroids | 2608 | 5949-44-0 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 5, 2014 | FDA | ENDO PHARMS INC |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Pulmonary oil microembolism | 321.84 | 32.20 | 36 | 1246 | 12 | 34955637 |
| Cough | 115.15 | 32.20 | 70 | 1212 | 150070 | 34805579 |
| Blood testosterone decreased | 76.91 | 32.20 | 20 | 1262 | 4337 | 34951312 |
| Drug ineffective | 75.07 | 32.20 | 87 | 1195 | 456664 | 34498985 |
| Pulmonary microemboli | 70.49 | 32.20 | 8 | 1274 | 4 | 34955645 |
| Microembolism | 62.90 | 32.20 | 8 | 1274 | 23 | 34955626 |
| Inappropriate schedule of product administration | 44.71 | 32.20 | 28 | 1254 | 62268 | 34893381 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Pulmonary oil microembolism | 244.00 | 27.90 | 25 | 1020 | 16 | 79743327 |
| Cough | 80.16 | 27.90 | 53 | 992 | 366736 | 79376607 |
| Pulmonary microemboli | 54.56 | 27.90 | 6 | 1039 | 13 | 79743330 |
| Blood testosterone decreased | 53.62 | 27.90 | 11 | 1034 | 2366 | 79740977 |
| Microembolism | 30.80 | 27.90 | 4 | 1041 | 47 | 79743296 |
| Inappropriate schedule of product administration | 30.62 | 27.90 | 20 | 1025 | 133608 | 79609735 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| FDA CS | M0001109 | Androstanes |
| FDA MoA | N0000000146 | Androgen Receptor Agonists |
| MeSH PA | D000728 | Androgens |
| MeSH PA | D006728 | Hormones |
| FDA EPC | N0000175824 | Androgen |
| CHEBI has role | CHEBI:50113 | androgene |
| CHEBI has role | CHEBI:75771 | Mus musculus metabolites |
| CHEBI has role | CHEBI:77746 | Homo sapiens metabolite |
| CHEBI has role | CHEBI:83056 | Daphnia magna metabolites |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Hypogonadotropic hypogonadism | indication | 33927004 | |
| Deficiency or absence of endogenous testosterone | indication | 38825009 | |
| Primary hypogonadism | indication | 370999003 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 158MG | JATENZO | TOLMAR | N206089 | March 27, 2019 | RX | CAPSULE | ORAL | 11331325 | Jan. 6, 2027 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 198MG | JATENZO | TOLMAR | N206089 | March 27, 2019 | RX | CAPSULE | ORAL | 11331325 | Jan. 6, 2027 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 237MG | JATENZO | TOLMAR | N206089 | March 27, 2019 | RX | CAPSULE | ORAL | 11331325 | Jan. 6, 2027 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 750MG/3ML (250MG/ML) | AVEED | ENDO PHARMS INC | N022219 | March 5, 2014 | RX | INJECTABLE | INTRAMUSCULAR | 8338395 | May 8, 2027 | TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED). |
| 112.5MG | TLANDO | ANTARES PHARMA INC | N208088 | March 28, 2022 | RX | CAPSULE | ORAL | 11304960 | Jan. 8, 2029 | TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED). |
| 112.5MG | TLANDO | ANTARES PHARMA INC | N208088 | March 28, 2022 | RX | CAPSULE | ORAL | 8778922 | Jan. 8, 2029 | TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED). |
| 112.5MG | TLANDO | ANTARES PHARMA INC | N208088 | March 28, 2022 | RX | CAPSULE | ORAL | 8865695 | Jan. 8, 2029 | TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED). |
| 158MG | JATENZO | TOLMAR | N206089 | March 27, 2019 | RX | CAPSULE | ORAL | 8241664 | March 29, 2029 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 198MG | JATENZO | TOLMAR | N206089 | March 27, 2019 | RX | CAPSULE | ORAL | 8241664 | March 29, 2029 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 237MG | JATENZO | TOLMAR | N206089 | March 27, 2019 | RX | CAPSULE | ORAL | 8241664 | March 29, 2029 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 158MG | JATENZO | TOLMAR | N206089 | March 27, 2019 | RX | CAPSULE | ORAL | 10543219 | April 12, 2030 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 158MG | JATENZO | TOLMAR | N206089 | March 27, 2019 | RX | CAPSULE | ORAL | 11179403 | April 12, 2030 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 158MG | JATENZO | TOLMAR | N206089 | March 27, 2019 | RX | CAPSULE | ORAL | 11426416 | April 12, 2030 | A METHOD OF TREATING TESTOSTERONE DEFICIENCY IN MEN |
| 198MG | JATENZO | TOLMAR | N206089 | March 27, 2019 | RX | CAPSULE | ORAL | 10543219 | April 12, 2030 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 198MG | JATENZO | TOLMAR | N206089 | March 27, 2019 | RX | CAPSULE | ORAL | 11179403 | April 12, 2030 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 198MG | JATENZO | TOLMAR | N206089 | March 27, 2019 | RX | CAPSULE | ORAL | 11426416 | April 12, 2030 | A METHOD OF TREATING TESTOSTERONE DEFICIENCY IN MEN |
| 237MG | JATENZO | TOLMAR | N206089 | March 27, 2019 | RX | CAPSULE | ORAL | 10543219 | April 12, 2030 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 237MG | JATENZO | TOLMAR | N206089 | March 27, 2019 | RX | CAPSULE | ORAL | 11179403 | April 12, 2030 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 237MG | JATENZO | TOLMAR | N206089 | March 27, 2019 | RX | CAPSULE | ORAL | 11426416 | April 12, 2030 | A METHOD OF TREATING TESTOSTERONE DEFICIENCY IN MEN |
| 112.5MG | TLANDO | ANTARES PHARMA INC | N208088 | March 28, 2022 | RX | CAPSULE | ORAL | 10226473 | Nov. 30, 2030 | TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED). |
| 112.5MG | TLANDO | ANTARES PHARMA INC | N208088 | March 28, 2022 | RX | CAPSULE | ORAL | 10716794 | Nov. 30, 2030 | TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED). |
| 112.5MG | TLANDO | ANTARES PHARMA INC | N208088 | March 28, 2022 | RX | CAPSULE | ORAL | 11311555 | Nov. 30, 2030 | TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED). |
| 112.5MG | TLANDO | ANTARES PHARMA INC | N208088 | March 28, 2022 | RX | CAPSULE | ORAL | 11364249 | Nov. 30, 2030 | TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED). |
| 112.5MG | TLANDO | ANTARES PHARMA INC | N208088 | March 28, 2022 | RX | CAPSULE | ORAL | 11433083 | Nov. 30, 2030 | TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED). |
| 112.5MG | TLANDO | ANTARES PHARMA INC | N208088 | March 28, 2022 | RX | CAPSULE | ORAL | 9943527 | Nov. 30, 2030 | TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED). |
| 112.5MG | TLANDO | ANTARES PHARMA INC | N208088 | March 28, 2022 | RX | CAPSULE | ORAL | 9949985 | Nov. 30, 2030 | TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED). |
| 158MG | JATENZO | TOLMAR | N206089 | March 27, 2019 | RX | CAPSULE | ORAL | 8492369 | Dec. 20, 2030 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 198MG | JATENZO | TOLMAR | N206089 | March 27, 2019 | RX | CAPSULE | ORAL | 8492369 | Dec. 20, 2030 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 237MG | JATENZO | TOLMAR | N206089 | March 27, 2019 | RX | CAPSULE | ORAL | 8492369 | Dec. 20, 2030 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 100MG | KYZATREX | MARIUS PHARMS LLC | N213953 | July 27, 2022 | RX | CAPSULE | ORAL | 10576089 | Dec. 31, 2030 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 150MG | KYZATREX | MARIUS PHARMS LLC | N213953 | July 27, 2022 | RX | CAPSULE | ORAL | 10576089 | Dec. 31, 2030 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 200MG | KYZATREX | MARIUS PHARMS LLC | N213953 | July 27, 2022 | RX | CAPSULE | ORAL | 10576089 | Dec. 31, 2030 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 100MG | KYZATREX | MARIUS PHARMS LLC | N213953 | July 27, 2022 | RX | CAPSULE | ORAL | 11617758 | March 15, 2033 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 150MG | KYZATREX | MARIUS PHARMS LLC | N213953 | July 27, 2022 | RX | CAPSULE | ORAL | 11617758 | March 15, 2033 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 200MG | KYZATREX | MARIUS PHARMS LLC | N213953 | July 27, 2022 | RX | CAPSULE | ORAL | 11617758 | March 15, 2033 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 112.5MG | TLANDO | ANTARES PHARMA INC | N208088 | March 28, 2022 | RX | CAPSULE | ORAL | 11559530 | Nov. 28, 2037 | TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED). |
| 158MG | JATENZO | TOLMAR | N206089 | March 27, 2019 | RX | CAPSULE | ORAL | 11564933 | April 12, 2039 | TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE |
| 198MG | JATENZO | TOLMAR | N206089 | March 27, 2019 | RX | CAPSULE | ORAL | 11564933 | April 12, 2039 | TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE |
| 237MG | JATENZO | TOLMAR | N206089 | March 27, 2019 | RX | CAPSULE | ORAL | 11564933 | April 12, 2039 | TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE |
| 112.5MG | TLANDO | ANTARES PHARMA INC | N208088 | March 28, 2022 | RX | CAPSULE | ORAL | 11464735 | April 28, 2041 | TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED). |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 112.5MG | TLANDO | ANTARES PHARMA INC | N208088 | March 28, 2022 | RX | CAPSULE | ORAL | March 28, 2025 | NEW PRODUCT |
| 100MG | KYZATREX | MARIUS PHARMS LLC | N213953 | July 27, 2022 | RX | CAPSULE | ORAL | July 27, 2025 | NEW PRODUCT |
| 150MG | KYZATREX | MARIUS PHARMS LLC | N213953 | July 27, 2022 | RX | CAPSULE | ORAL | July 27, 2025 | NEW PRODUCT |
| 200MG | KYZATREX | MARIUS PHARMS LLC | N213953 | July 27, 2022 | RX | CAPSULE | ORAL | July 27, 2025 | NEW PRODUCT |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Androgen receptor | Nuclear hormone receptor | AGONIST | CHEMBL | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4033172 | VUID |
| N0000190487 | NUI |
| D06087 | KEGG_DRUG |
| 4017484 | VANDF |
| 4033172 | VANDF |
| C0076195 | UMLSCUI |
| CHEBI:135741 | CHEBI |
| CHEBI:17347 | CHEBI |
| TES | PDB_CHEM_ID |
| CHEMBL2107067 | ChEMBL_ID |
| DB13946 | DRUGBANK_ID |
| C010792 | MESH_SUPPLEMENTAL_RECORD_UI |
| H16A5VCT9C | UNII |
| 65157 | PUBCHEM_CID |
| DB00624 | DRUGBANK_ID |
| 10379 | RXNORM |
| 15462 | MMSL |
| 2966 | MMSL |
| 5552 | MMSL |
| d00558 | MMSL |
| 001245 | NDDF |
| 004105 | NDDF |
| 109033004 | SNOMEDCT_US |
| 395900004 | SNOMEDCT_US |
| 43688007 | SNOMEDCT_US |
| C0039601 | UMLSCUI |
| 1900 | INN_ID |
| 6013 | PUBCHEM_CID |
| D013739 | MESH_DESCRIPTOR_UI |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Tlando | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54436-112 | CAPSULE, LIQUID FILLED | 112.50 mg | ORAL | NDA | 31 sections |
| Aveed | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67979-511 | INJECTION | 250 mg | INTRAMUSCULAR | NDA | 29 sections |
| Aveed | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67979-511 | INJECTION | 250 mg | INTRAMUSCULAR | NDA | 29 sections |
| Jatenzo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69087-158 | CAPSULE, LIQUID FILLED | 158 mg | ORAL | NDA | 32 sections |
| Jatenzo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69087-158 | CAPSULE, LIQUID FILLED | 158 mg | ORAL | NDA | 32 sections |
| Jatenzo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69087-198 | CAPSULE, LIQUID FILLED | 198 mg | ORAL | NDA | 32 sections |
| Jatenzo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69087-198 | CAPSULE, LIQUID FILLED | 198 mg | ORAL | NDA | 32 sections |
| Jatenzo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69087-237 | CAPSULE, LIQUID FILLED | 237 mg | ORAL | NDA | 32 sections |
| Jatenzo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69087-237 | CAPSULE, LIQUID FILLED | 237 mg | ORAL | NDA | 32 sections |
| Kyzatrex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80603-101 | CAPSULE, LIQUID FILLED | 100 mg | ORAL | NDA | 36 sections |
| Kyzatrex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80603-103 | CAPSULE, LIQUID FILLED | 150 mg | ORAL | NDA | 36 sections |
| Kyzatrex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80603-105 | CAPSULE, LIQUID FILLED | 200 mg | ORAL | NDA | 36 sections |