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testosterone undecanoate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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:
| Property | Value | Reference |
|---|---|---|
| BA (Bioavailability) | 4 % |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 5.206 | High | 0.80 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 1.035 | High | 0.80 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 0.269 | 10^-6 cm/s | High | 0.80 |
| dh-clint | Dog hepatocyte intrinsic clearance | 83.368 | uL/min/10^6 cells | High | 0.80 |
| dppb | Dog plasma protein binding (% unbound) | 0.110 | % | High | 0.80 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 0.060 | % | High | 0.80 |
| herg | hERG pIC50 | 4.886 | pIC50 | High | 0.80 |
| hh-clint | Human hepatocyte intrinsic clearance | 81.470 | uL/min/10^6 cells | High | 0.80 |
| hlm-clint | Human liver microsomal intrinsic clearance | 111.944 | uL/min/mg protein | High | 0.80 |
| hppb | Human plasma protein binding (% unbound) | 0.270 | % | High | 0.80 |
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 0.044 | High | 0.80 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 168.267 | High | 0.80 | |
| mppb | Mouse plasma protein binding (% unbound) | 0.150 | High | 0.80 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 0.034 | High | 0.80 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 0.180 | % | High | 0.80 |
| rh-clint | Rat hepatocyte intrinsic clearance | 137.088 | uL/min/10^6 cells | High | 0.80 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 0.150 | % | High | 0.80 |
| rppb | Rat plasma protein binding (% unbound) | 0.140 | % | High | 0.80 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 0.745 | uM | High | 0.80 |
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 | 346.71 | 28.15 | 40 | 1749 | 21 | 42619525 |
| Cough | 97.44 | 28.15 | 71 | 1718 | 178032 | 42441514 |
| Blood testosterone decreased | 90.58 | 28.15 | 24 | 1765 | 4878 | 42614668 |
| Polycythaemia | 67.25 | 28.15 | 17 | 1772 | 2869 | 42616677 |
| Pulmonary microemboli | 63.22 | 28.15 | 8 | 1781 | 18 | 42619528 |
| Microembolism | 61.81 | 28.15 | 8 | 1781 | 23 | 42619523 |
| Drug ineffective | 60.99 | 28.15 | 100 | 1689 | 630097 | 41989449 |
| Haematocrit increased | 54.30 | 28.15 | 14 | 1775 | 2553 | 42616993 |
| Blood testosterone increased | 50.58 | 28.15 | 12 | 1777 | 1555 | 42617991 |
| Inappropriate schedule of product administration | 40.69 | 28.15 | 33 | 1756 | 95869 | 42523677 |
| Pneumonia haemophilus | 33.57 | 28.15 | 8 | 1781 | 1056 | 42618490 |
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 | 279.47 | 27.10 | 29 | 1412 | 25 | 110587833 |
| Cough | 71.34 | 27.10 | 54 | 1387 | 461587 | 110126271 |
| Blood testosterone decreased | 57.43 | 27.10 | 12 | 1429 | 2836 | 110585022 |
| Polycythaemia | 55.76 | 27.10 | 12 | 1429 | 3263 | 110584595 |
| Pulmonary microemboli | 51.10 | 27.10 | 6 | 1435 | 28 | 110587830 |
| Blood testosterone increased | 46.85 | 27.10 | 9 | 1432 | 1393 | 110586465 |
| Pneumonia haemophilus | 35.43 | 27.10 | 8 | 1433 | 2707 | 110585151 |
| Idiopathic intracranial hypertension | 32.44 | 27.10 | 8 | 1433 | 3944 | 110583914 |
| Microembolism | 31.06 | 27.10 | 4 | 1437 | 44 | 110587814 |
| Haematocrit increased | 30.64 | 27.10 | 8 | 1433 | 4951 | 110582907 |
| Inappropriate schedule of product administration | 27.32 | 27.10 | 22 | 1419 | 203615 | 110384243 |
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:35480 | analgesic |
| CHEBI has role | CHEBI:35554 | cardiovascular drug |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:35620 | vasodilator agent |
| CHEBI has role | CHEBI:35705 | immunosuppressive agent |
| CHEBI has role | CHEBI:50113 | androgen |
| CHEBI has role | CHEBI:50779 | appetite enhancer |
| CHEBI has role | CHEBI:50864 | insulin-sensitizing drug |
| CHEBI has role | CHEBI:74518 | anti-obesity agent |
| CHEBI has role | CHEBI:75771 | mouse metabolite |
| CHEBI has role | CHEBI:77746 | human metabolite |
| CHEBI has role | CHEBI:83056 | <em>Daphnia magna</em> metabolite |
| CHEBI has role | CHEBI:176497 | geroprotector |
| CHEBI has role | CHEBI:231911 | renoprotective agent |
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 OPERATIONS | 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 | VERITY | 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 | VERITY | 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 | VERITY | 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 | VERITY | 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 | VERITY | 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 | VERITY | 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 | VERITY | 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 | VERITY | 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 | VERITY | 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 | VERITY | 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 | N213953 | July 27, 2022 | DISCN | CAPSULE | ORAL | 10576089 | Dec. 31, 2030 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 150MG | KYZATREX | MARIUS | N213953 | July 27, 2022 | RX | CAPSULE | ORAL | 10576089 | Dec. 31, 2030 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 200MG | KYZATREX | MARIUS | N213953 | July 27, 2022 | RX | CAPSULE | ORAL | 10576089 | Dec. 31, 2030 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 100MG | KYZATREX | MARIUS | N213953 | July 27, 2022 | DISCN | CAPSULE | ORAL | 11617758 | March 15, 2033 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 100MG | KYZATREX | MARIUS | N213953 | July 27, 2022 | DISCN | CAPSULE | ORAL | 12357643 | March 15, 2033 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 150MG | KYZATREX | MARIUS | N213953 | July 27, 2022 | RX | CAPSULE | ORAL | 11617758 | March 15, 2033 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 150MG | KYZATREX | MARIUS | N213953 | July 27, 2022 | RX | CAPSULE | ORAL | 12357643 | March 15, 2033 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 200MG | KYZATREX | MARIUS | N213953 | July 27, 2022 | RX | CAPSULE | ORAL | 11617758 | March 15, 2033 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 200MG | KYZATREX | MARIUS | N213953 | July 27, 2022 | RX | CAPSULE | ORAL | 12357643 | March 15, 2033 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 112.5MG | TLANDO | VERITY | 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). |
| 112.5MG | TLANDO | VERITY | N208088 | March 28, 2022 | RX | CAPSULE | ORAL | 12310978 | Feb. 21, 2039 | METHODS OF RESTORING TESTOSTERONE CONCENTRATION FOR CONDITIONS ASSOCIATED WITH DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE IN A MALE SUBJECT |
| 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 |
| 158MG | JATENZO | TOLMAR | N206089 | March 27, 2019 | RX | CAPSULE | ORAL | 12605391 | 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 |
| 198MG | JATENZO | TOLMAR | N206089 | March 27, 2019 | RX | CAPSULE | ORAL | 12605391 | 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 |
| 237MG | JATENZO | TOLMAR | N206089 | March 27, 2019 | RX | CAPSULE | ORAL | 12605391 | April 12, 2039 | TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE |
| 112.5MG | TLANDO | VERITY | N208088 | March 28, 2022 | RX | CAPSULE | ORAL | 12011503 | Oct. 16, 2040 | METHODS OF ADMINISTERING TESTOSTERONE UNDECANOATE FOR RESTORING TESTOSTERONE CONCENTRATION IN A HYPOGONADAL MALE SUBJECT |
| 112.5MG | TLANDO | VERITY | N208088 | March 28, 2022 | RX | CAPSULE | ORAL | 12011503 | Oct. 16, 2040 | METHODS OF CONTINUING OR DISCONTINUING A DOSAGE REGIMEN OF A TESTOSTERONE UNDECANOATE PHARMACEUTICAL COMPOSITION TO A HYPOGONADAL MALE SUBJECT |
| 100MG | KYZATREX | MARIUS | N213953 | July 27, 2022 | DISCN | CAPSULE | ORAL | 12403146 | March 29, 2041 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 150MG | KYZATREX | MARIUS | N213953 | July 27, 2022 | RX | CAPSULE | ORAL | 12403146 | March 29, 2041 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 200MG | KYZATREX | MARIUS | N213953 | July 27, 2022 | RX | CAPSULE | ORAL | 12403146 | March 29, 2041 | METHOD OF TREATING TESTOSTERONE DEFICIENCY |
| 112.5MG | TLANDO | VERITY | 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)
None
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 |
| 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 |
| 6013 | PUBCHEM_CID |
| 1900 | INN_ID |
| D013739 | MESH_DESCRIPTOR_UI |
| CHEBI:17347 | CHEBI |
| H16A5VCT9C | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 | 69087-198 | 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 |
| Undecatrex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73352-105 | CAPSULE | 200 mg | ORAL | NDA AUTHORIZED GENERIC | 36 sections |
| Tlando | HUMAN PRESCRIPTION DRUG LABEL | 1 | 74676-0112 | CAPSULE, LIQUID FILLED | 112.50 mg | ORAL | NDA | 33 sections |
| Kyzatrex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80603-101 | CAPSULE, LIQUID FILLED | 100 mg | ORAL | NDA | 36 sections |
| Kyzatrex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80603-101 | 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 | 80603-103 | 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 |
| Kyzatrex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80603-105 | CAPSULE, LIQUID FILLED | 200 mg | ORAL | NDA | 36 sections |