testosterone Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
androgens/anabolic steroids 2607 58-22-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • testosterone
  • 17beta-Testosterone
A potent androgenic steroid and major product secreted by the LEYDIG CELLS of the TESTIS. Its production is stimulated by LUTEINIZING HORMONE from the PITUITARY GLAND. In turn, testosterone exerts feedback control of the pituitary LH and FSH secretion. Depending on the tissues, testosterone can be further converted to DIHYDROTESTOSTERONE or ESTRADIOL.
  • Molecular weight: 288.43
  • Formula: C19H28O2
  • CLOGP: 3.41
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 1
  • TPSA: 37.30
  • ALOGS: -3.94
  • ROTB: 0
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.12 g O
18 mg P
0.12 g R
60 mg SL
50 mg TD
3 mg TD

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.02 mg/mL Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 2.97 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 4 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.35 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 24.50 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.06 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.17 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
July 13, 1972 FDA ACTIENT PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Accidental exposure to product 326.04 68.19 60 165 8437 2349423
Blood testosterone increased 306.38 68.19 32 193 35 2357825
Hair growth abnormal 186.51 68.19 26 199 566 2357294
Enlarged clitoris 144.65 68.19 16 209 39 2357821
Virilism 81.80 68.19 9 216 20 2357840
Precocious puberty 71.31 68.19 9 216 84 2357776

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Blood testosterone decreased 1667.09 30.40 281 2558 771 1743171
Blood testosterone increased 551.03 30.40 91 2748 200 1743742
Deep vein thrombosis 536.37 30.40 169 2670 9751 1734191
Product administered at inappropriate site 363.84 30.40 69 2770 412 1743530
Pulmonary embolism 354.22 30.40 133 2706 12926 1731016
Application site rash 342.29 30.40 60 2779 211 1743731
Drug ineffective 295.72 30.40 194 2645 63607 1680335
Polycythaemia 248.76 30.40 48 2791 317 1743625
Product deposit 211.56 30.40 35 2804 77 1743865
Blood testosterone abnormal 183.92 30.40 30 2809 58 1743884
Haematocrit increased 183.81 30.40 36 2803 259 1743683
Application site erythema 183.42 30.40 41 2798 593 1743349
Myocardial infarction 179.17 30.40 104 2735 27070 1716872
Drug abuse 178.77 30.40 83 2756 13606 1730336
Prostate cancer 157.85 30.40 56 2783 4570 1739372
Prostatic specific antigen increased 151.88 30.40 47 2792 2499 1741443
Incorrect dose administered 149.12 30.40 61 2778 7348 1736594
Application site pruritus 143.79 30.40 30 2809 306 1743636
Testicular atrophy 142.78 30.40 27 2812 157 1743785
Cerebrovascular accident 135.34 30.40 75 2764 17791 1726151
Thrombosis 131.41 30.40 56 2783 7465 1736477
Application site pain 130.90 30.40 32 2807 694 1743248
Gynaecomastia 125.62 30.40 39 2800 2093 1741849
Precocious puberty 122.46 30.40 20 2819 39 1743903
Osteonecrosis 116.53 30.40 43 2796 3919 1740023
Product quality issue 115.19 30.40 48 2791 6045 1737897
Acute myocardial infarction 114.80 30.40 53 2786 8534 1735408
Application site reaction 110.55 30.40 22 2817 173 1743769
Coronary artery disease 101.94 30.40 51 2788 9795 1734147
Asthenia 98.58 30.40 79 2760 34591 1709351
Fatigue 98.57 30.40 93 2746 50688 1693254
Libido decreased 94.12 30.40 28 2811 1297 1742645
Application site vesicles 86.74 30.40 18 2821 178 1743764
Azoospermia 85.85 30.40 18 2821 188 1743754
Hair growth abnormal 83.64 30.40 18 2821 215 1743727
Product odour abnormal 81.61 30.40 18 2821 243 1743699
Rash 77.09 30.40 72 2767 38621 1705321
Acne 73.59 30.40 25 2814 1783 1742159
Application site exfoliation 70.53 30.40 13 2826 64 1743878
Application site dryness 69.81 30.40 12 2827 36 1743906
Muscle mass 67.75 30.40 12 2827 45 1743897
Poor quality product administered 64.13 30.40 17 2822 513 1743429
Application site irritation 62.92 30.40 14 2825 197 1743745
Product administration error 61.64 30.40 25 2814 2928 1741014
Wrong technique in product usage process 60.42 30.40 37 2802 10498 1733444
Hyperhidrosis 59.49 30.40 39 2800 12449 1731493
Blood testosterone free decreased 58.68 30.40 10 2829 28 1743914
Aggression 58.35 30.40 33 2806 8082 1735860
Depression 58.18 30.40 43 2796 16626 1727316
Left ventricular hypertrophy 56.15 30.40 17 2822 835 1743107
Infertility male 55.32 30.40 12 2827 149 1743793
Infertility 54.88 30.40 12 2827 155 1743787
Application site discolouration 54.87 30.40 11 2828 90 1743852
Drug-disease interaction 54.46 30.40 10 2829 48 1743894
Haemoglobin increased 53.75 30.40 15 2824 551 1743391
Headache 53.55 30.40 56 2783 34320 1709622
Off label use 53.36 30.40 59 2780 38512 1705430
Skin irritation 53.28 30.40 16 2823 764 1743178
Application site urticaria 50.97 30.40 9 2830 33 1743909
Accidental exposure to product 50.65 30.40 24 2815 4077 1739865
Myocardial fibrosis 50.10 30.40 11 2828 145 1743797
Transient ischaemic attack 50.04 30.40 25 2814 4766 1739176
Oedema peripheral 49.55 30.40 38 2801 15512 1728430
Product physical consistency issue 48.44 30.40 10 2829 96 1743846
Oestradiol increased 47.60 30.40 8 2831 20 1743922
Portal vein thrombosis 46.37 30.40 14 2825 681 1743261
Cardiomyopathy 46.35 30.40 20 2819 2732 1741210
Pain in extremity 45.84 30.40 39 2800 18433 1725509
Pruritus 45.70 30.40 43 2796 23179 1720763
Erectile dysfunction 45.59 30.40 23 2816 4474 1739468
Product physical issue 44.80 30.40 13 2826 550 1743392
Cardiac death 44.72 30.40 11 2828 244 1743698
Mesenteric vein thrombosis 44.47 30.40 10 2829 148 1743794
Chest pain 43.30 30.40 39 2800 19875 1724067
Prostatomegaly 42.51 30.40 13 2826 660 1743282
Anxiety 41.03 30.40 34 2805 15493 1728449
Breast tenderness 40.78 30.40 10 2829 219 1743723
Inappropriate schedule of product administration 39.70 30.40 25 2814 7434 1736508
Hypercoagulation 39.48 30.40 10 2829 251 1743691
Atrial fibrillation 37.67 30.40 32 2807 15079 1728863
Intentional product misuse 37.51 30.40 24 2815 7334 1736608
Hyperlipidaemia 36.88 30.40 16 2823 2213 1741729
Hypogonadism 36.74 30.40 10 2829 334 1743608
Insomnia 35.61 30.40 32 2807 16244 1727698
Therapeutic response unexpected 35.59 30.40 16 2823 2408 1741534
Pain 35.46 30.40 40 2799 26617 1717325
Chorioretinopathy 35.24 30.40 10 2829 390 1743552
Alopecia 34.57 30.40 18 2821 3735 1740207
Weight increased 34.51 30.40 27 2812 11330 1732612
Retinal vein occlusion 34.12 30.40 10 2829 438 1743504
Hypertension 32.59 30.40 33 2806 19415 1724527
Musculoskeletal pain 32.10 30.40 19 2820 5055 1738887
Sleep apnoea syndrome 30.93 30.40 14 2825 2140 1741802

Pharmacologic Action:

SourceCodeDescription
ATC G03BA03 GENITO URINARY SYSTEM AND SEX HORMONES
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
ANDROGENS
3-oxoandrosten (4) derivatives
ATC G03EA02 GENITO URINARY SYSTEM AND SEX HORMONES
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
ANDROGENS AND FEMALE SEX HORMONES IN COMBINATION
Androgens and estrogens
FDA EPC N0000175824 Androgen
FDA MoA N0000000146 Androgen Receptor Agonists
FDA CS M0001109 Androstanes
MeSH PA D000728 Androgens
MeSH PA D006728 Hormones

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Hypogonadotropic hypogonadism indication 33927004
Deficiency of testosterone biosynthesis indication 38825009
Inhibition of lactation procedure indication 43141007
Male hypogonadism indication 48723006
Hypopituitarism indication 74728003 DOID:9406
Menopausal flushing indication 198436008
Undescended testicle indication 204878001 DOID:11383
Bilateral orchidectomy indication 386634006
Delayed puberty indication 400003000
Klinefelter's syndrome, XXY indication 405769009
Hormone receptor positive malignant neoplasm of breast indication 417181009
Primary Hypogonadism due to Bilateral Torsion indication
Primary Hypogonadism due to Orchitis indication
LHRH Deficiency indication
Chemotherapy-Induced Hypogonadism indication
Bilateral Anorchia indication
Noonan's syndrome off-label use 205824006 DOID:3490
Hyperlipoproteinemia contraindication 3744001 DOID:1168
Gynecomastia contraindication 4754008 DOID:12698
Hypocalcemia contraindication 5291005
Hypercholesterolemia contraindication 13644009
Myocardial infarction contraindication 22298006 DOID:5844
Chloasma contraindication 36209000
Migraine contraindication 37796009 DOID:6364
Hypertensive disorder contraindication 38341003 DOID:10763
Disorder of gallbladder contraindication 39621005 DOID:0060262
Hypothyroidism contraindication 40930008 DOID:1459
Body fluid retention contraindication 43498006
Thrombosis of retinal vein contraindication 46085004
Humoral hypercalcemia of malignancy contraindication 47709007
Chronic heart failure contraindication 48447003
Dementia contraindication 52448006
Hepatic porphyria contraindication 55056006 DOID:3133
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Heart disease contraindication 56265001 DOID:114
Thrombophlebitis contraindication 64156001 DOID:3875
Intermenstrual bleeding - irregular contraindication 64996003
Hypercalcemia contraindication 66931009 DOID:12678
Arteriosclerotic vascular disease contraindication 72092001
Diabetes mellitus contraindication 73211009 DOID:9351
Sleep apnea contraindication 73430006 DOID:0050847
Heart failure contraindication 84114007 DOID:6000
Epilepsy contraindication 84757009 DOID:1826
Breast lump contraindication 89164003
Kidney disease contraindication 90708001 DOID:557
Uterine leiomyoma contraindication 95315005 DOID:13223
Magnetic resonance imaging contraindication 113091000
Neoplasm of liver contraindication 126851005 DOID:3571
Neoplasm of prostate contraindication 126906006 DOID:10283
Deep venous thrombosis contraindication 128053003
Endometriosis contraindication 129103003
Mammography abnormal contraindication 168750009
Asthma contraindication 195967001 DOID:2841
Cerebrovascular accident contraindication 230690007
Pulmonary thromboembolism contraindication 233935004
Thrombophilia contraindication 234467004 DOID:2452
Disease of liver contraindication 235856003 DOID:409
Endometrial carcinoma contraindication 254878006 DOID:2871
Benign prostatic hyperplasia contraindication 266569009
Edema contraindication 267038008
Chorea contraindication 271700006
Pregnancy, function contraindication 289908002
Hypertriglyceridemia contraindication 302870006
Functional visual loss contraindication 313165001
Malignant tumor of ovary contraindication 363443007 DOID:2394
Thromboembolic disorder contraindication 371039008
Cardiovascular event risk contraindication 395112001
Breastfeeding (mother) contraindication 413712001
Chronic lung disease contraindication 413839001
Disorder of coronary artery contraindication 414024009
Obesity contraindication 414916001 DOID:9970
Estrogen receptor positive tumor contraindication 416053008
Family history of malignant neoplasm of breast contraindication 429740004
Hypertensive urgency contraindication 443482000
Carcinoma of female breast contraindication 447782002
Smokes tobacco daily contraindication 449868002
Breast Carcinoma in Males contraindication

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
12.5MG/1.25GM ACTUATION ANDROGEL ABBVIE N021015 Sept. 26, 2003 DISCN GEL, METERED TRANSDERMAL 6503894 Aug. 30, 2020 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
12.5MG/1.25GM ACTUATION ANDROGEL ABBVIE N021015 Sept. 26, 2003 DISCN GEL, METERED TRANSDERMAL 9125816 Aug. 30, 2020 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
12.5MG/1.25GM ACTUATION ANDROGEL ABBVIE N021015 Sept. 26, 2003 DISCN GEL, METERED TRANSDERMAL 9132089 Aug. 30, 2020 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
25MG/2.5GM PACKET ANDROGEL ABBVIE N021015 Feb. 28, 2000 RX GEL TRANSDERMAL 6503894 Aug. 30, 2020 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
25MG/2.5GM PACKET ANDROGEL ABBVIE N021015 Feb. 28, 2000 RX GEL TRANSDERMAL 9125816 Aug. 30, 2020 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
25MG/2.5GM PACKET ANDROGEL ABBVIE N021015 Feb. 28, 2000 RX GEL TRANSDERMAL 9132089 Aug. 30, 2020 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
50MG/5GM PACKET ANDROGEL ABBVIE N021015 Feb. 28, 2000 RX GEL TRANSDERMAL 6503894 Aug. 30, 2020 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
50MG/5GM PACKET ANDROGEL ABBVIE N021015 Feb. 28, 2000 RX GEL TRANSDERMAL 9125816 Aug. 30, 2020 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
50MG/5GM PACKET ANDROGEL ABBVIE N021015 Feb. 28, 2000 RX GEL TRANSDERMAL 9132089 Aug. 30, 2020 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (20.25MG/1.25GM ACTUATION) ANDROGEL ABBVIE N022309 April 29, 2011 RX GEL, METERED TRANSDERMAL 6503894 Aug. 30, 2020 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (20.25MG/1.25GM ACTUATION) ANDROGEL ABBVIE N022309 April 29, 2011 RX GEL, METERED TRANSDERMAL 9125816 Aug. 30, 2020 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (20.25MG/1.25GM ACTUATION) ANDROGEL ABBVIE N022309 April 29, 2011 RX GEL, METERED TRANSDERMAL 9132089 Aug. 30, 2020 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (20.25MG/1.25GM PACKET) ANDROGEL ABBVIE N022309 Sept. 7, 2012 RX GEL TRANSDERMAL 6503894 Aug. 30, 2020 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (20.25MG/1.25GM PACKET) ANDROGEL ABBVIE N022309 Sept. 7, 2012 RX GEL TRANSDERMAL 9125816 Aug. 30, 2020 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (20.25MG/1.25GM PACKET) ANDROGEL ABBVIE N022309 Sept. 7, 2012 RX GEL TRANSDERMAL 9132089 Aug. 30, 2020 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (40.5MG/2.5GM PACKET) ANDROGEL ABBVIE N022309 Sept. 7, 2012 RX GEL TRANSDERMAL 6503894 Aug. 30, 2020 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (40.5MG/2.5GM PACKET) ANDROGEL ABBVIE N022309 Sept. 7, 2012 RX GEL TRANSDERMAL 9125816 Aug. 30, 2020 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (40.5MG/2.5GM PACKET) ANDROGEL ABBVIE N022309 Sept. 7, 2012 RX GEL TRANSDERMAL 9132089 Aug. 30, 2020 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
50MG/5GM PACKET TESTIM AUXILIUM PHARMS LLC N021454 Oct. 31, 2002 RX GEL TRANSDERMAL 7608605 April 21, 2023 METHOD FOR ADMINISTRATION OF TESTOSTERONE
50MG/5GM PACKET TESTIM AUXILIUM PHARMS LLC N021454 Oct. 31, 2002 RX GEL TRANSDERMAL 7608606 April 21, 2023 METHOD FOR ADMINISTRATION OF TESTOSTERONE
50MG/5GM PACKET TESTIM AUXILIUM PHARMS LLC N021454 Oct. 31, 2002 RX GEL TRANSDERMAL 7608607 April 21, 2023 METHOD FOR ADMINISTRATION OF TESTOSTERONE
50MG/5GM PACKET TESTIM AUXILIUM PHARMS LLC N021454 Oct. 31, 2002 RX GEL TRANSDERMAL 7608608 April 21, 2023 METHOD FOR ADMINISTRATION OF TESTOSTERONE
50MG/5GM PACKET TESTIM AUXILIUM PHARMS LLC N021454 Oct. 31, 2002 RX GEL TRANSDERMAL 7608609 April 21, 2023 METHOD FOR ADMINISTRATION OF TESTOSTERONE
50MG/5GM PACKET TESTIM AUXILIUM PHARMS LLC N021454 Oct. 31, 2002 RX GEL TRANSDERMAL 7608610 April 21, 2023 METHOD FOR ADMINISTRATION OF TESTOSTERONE
50MG/5GM PACKET TESTIM AUXILIUM PHARMS LLC N021454 Oct. 31, 2002 RX GEL TRANSDERMAL 7935690 April 21, 2023 METHOD FOR ADMINISTRATION OF TESTOSTERONE
50MG/5GM PACKET TESTIM AUXILIUM PHARMS LLC N021454 Oct. 31, 2002 RX GEL TRANSDERMAL 8063029 April 21, 2023 METHOD FOR ADMINISTRATION OF TESTOSTERONE
30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** AXIRON ELI LILLY AND CO N022504 Nov. 23, 2010 DISCN SOLUTION, METERED TRANSDERMAL 8784878 July 13, 2023 A METHOD OF TRANSDERMALLY DELIVERING TESTOSTERONE
5.5MG/0.122GM ACTUATION NATESTO ACERUS N205488 May 28, 2014 RX GEL, METERED NASAL 8784882 Feb. 4, 2024 A METHOD OF TESTOSTERONE REPLACEMENT THERAPY COMPRISING THE STEP OF NASALLY ADMINISTERING TO A PATIENT IN NEED OF SUCH TREATMENT AN EFFECTIVE AMOUNT OF TESTOSTERONE GEL FORMULATION.
5.5MG/0.122GM ACTUATION NATESTO ACERUS N205488 May 28, 2014 RX GEL, METERED NASAL 8877230 Feb. 4, 2024 NASAL ADMINISTRATION OF A TESTOSTERONE GEL TO A PATIENT TO TREAT THE PATIENT FOR A CONDITION ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
50MG/5GM PACKET TESTIM AUXILIUM PHARMS LLC N021454 Oct. 31, 2002 RX GEL TRANSDERMAL 7320968 Jan. 18, 2025 METHOD FOR ADMINISTRATION OF TESTOSTERONE
30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** AXIRON ELI LILLY AND CO N022504 Nov. 23, 2010 DISCN SOLUTION, METERED TRANSDERMAL 8993520 June 2, 2026 A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF
30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** AXIRON ELI LILLY AND CO N022504 Nov. 23, 2010 DISCN SOLUTION, METERED TRANSDERMAL 9180194 June 2, 2026 A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF
1.62% (20.25MG/1.25GM ACTUATION) ANDROGEL ABBVIE N022309 April 29, 2011 RX GEL, METERED TRANSDERMAL 8466137 Oct. 12, 2026 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (20.25MG/1.25GM ACTUATION) ANDROGEL ABBVIE N022309 April 29, 2011 RX GEL, METERED TRANSDERMAL 8466138 Oct. 12, 2026 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (20.25MG/1.25GM ACTUATION) ANDROGEL ABBVIE N022309 April 29, 2011 RX GEL, METERED TRANSDERMAL 8741881 Oct. 12, 2026 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (20.25MG/1.25GM PACKET) ANDROGEL ABBVIE N022309 Sept. 7, 2012 RX GEL TRANSDERMAL 8466137 Oct. 12, 2026 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (20.25MG/1.25GM PACKET) ANDROGEL ABBVIE N022309 Sept. 7, 2012 RX GEL TRANSDERMAL 8466138 Oct. 12, 2026 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (20.25MG/1.25GM PACKET) ANDROGEL ABBVIE N022309 Sept. 7, 2012 RX GEL TRANSDERMAL 8741881 Oct. 12, 2026 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (40.5MG/2.5GM PACKET) ANDROGEL ABBVIE N022309 Sept. 7, 2012 RX GEL TRANSDERMAL 8466137 Oct. 12, 2026 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (40.5MG/2.5GM PACKET) ANDROGEL ABBVIE N022309 Sept. 7, 2012 RX GEL TRANSDERMAL 8466138 Oct. 12, 2026 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (40.5MG/2.5GM PACKET) ANDROGEL ABBVIE N022309 Sept. 7, 2012 RX GEL TRANSDERMAL 8741881 Oct. 12, 2026 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** AXIRON ELI LILLY AND CO N022504 Nov. 23, 2010 DISCN SOLUTION, METERED TRANSDERMAL 8419307 Feb. 26, 2027 A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF A PERSON IN NEED THEREOF
30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** AXIRON ELI LILLY AND CO N022504 Nov. 23, 2010 DISCN SOLUTION, METERED TRANSDERMAL 8807861 Feb. 26, 2027 A METHOD OF TRANSDERMAL ADMINISTRATION OF A PHYSIOLOGICALLY ACTIVE AGENT TO A SUBJECT.
30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** AXIRON ELI LILLY AND CO N022504 Nov. 23, 2010 DISCN SOLUTION, METERED TRANSDERMAL 9289586 Feb. 26, 2027 A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF
30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** AXIRON ELI LILLY AND CO N022504 Nov. 23, 2010 DISCN SOLUTION, METERED TRANSDERMAL 8435944 Sept. 27, 2027 A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF
12.5MG/1.25GM ACTUATION VOGELXO UPSHER SMITH LABS N204399 June 4, 2014 RX GEL, METERED TRANSDERMAL 8785426 Feb. 11, 2034 METHOD FOR TRANSDERMAL DELIVERY OF TESTOSTERONE
12.5MG/1.25GM ACTUATION VOGELXO UPSHER SMITH LABS N204399 June 4, 2014 RX GEL, METERED TRANSDERMAL 9295675 Feb. 11, 2034 METHOD FOR TRANSDERMAL DELIVERY OF TESTOSTERONE
12.5MG/1.25GM ACTUATION VOGELXO UPSHER SMITH LABS N204399 June 4, 2014 RX GEL, METERED TRANSDERMAL 9662340 Feb. 11, 2034 METHOD FOR TRANSDERMAL DELIVERY OF TESTOSTERONE
50MG/5GM PACKET VOGELXO UPSHER SMITH LABS N204399 June 4, 2014 RX GEL TRANSDERMAL 8785426 Feb. 11, 2034 METHOD FOR TRANSDERMAL DELIVERY OF TESTOSTERONE
50MG/5GM PACKET VOGELXO UPSHER SMITH LABS N204399 June 4, 2014 RX GEL TRANSDERMAL 9295675 Feb. 11, 2034 METHOD FOR TRANSDERMAL DELIVERY OF TESTOSTERONE
50MG/5GM PACKET VOGELXO UPSHER SMITH LABS N204399 June 4, 2014 RX GEL TRANSDERMAL 9662340 Feb. 11, 2034 METHOD FOR TRANSDERMAL DELIVERY OF TESTOSTERONE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Androgen receptor Nuclear hormone receptor AGONIST EC50 9.20 WOMBAT-PK CHEMBL
Glucocorticoid receptor Nuclear hormone receptor Ki 5.84 DRUG MATRIX
Aromatase Enzyme Ki 6.22 CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 5.92 CHEMBL
Sex hormone-binding globulin Secreted Kd 9.20 CHEMBL
Lanosterol 14-alpha demethylase Enzyme IC50 4.30 CHEMBL
Corticosteroid-binding globulin Secreted Ki 6.72 CHEMBL
Progesterone receptor Transcription factor Ki 6.60 DRUG MATRIX
Steroid 5-alpha-reductase Enzyme IC50 5.72 CHEMBL
Androgen receptor Transcription factor Ki 8.85 CHEMBL
Constitutive androstane receptor Unclassified IC50 4.52 CHEMBL
C-8 sterol isomerase Enzyme Ki 5.11 CHEMBL

External reference:

IDSource
4017484 VUID
N0000145872 NUI
C0039601 UMLSCUI
D00075 KEGG_DRUG
3XMK78S47O UNII
1900 INN_ID
109033004 SNOMEDCT_US
4017484 VANDF
2966 MMSL
10379 RXNORM
43688007 SNOMEDCT_US
5552 MMSL
d00558 MMSL
001245 NDDF
CHEBI:17347 CHEBI
CHEMBL386630 ChEMBL_ID
DB00624 DRUGBANK_ID
TES PDB_CHEM_ID
6013 PUBCHEM_CID
CHEMBL1201101 ChEMBL_ID
D013739 MESH_DESCRIPTOR_UI
2858 IUPHAR_LIGAND_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Androderm HUMAN PRESCRIPTION DRUG LABEL 1 0023-5990 PATCH 2 mg TRANSDERMAL NDA 18 sections
Androderm HUMAN PRESCRIPTION DRUG LABEL 1 0023-5992 PATCH 4 mg TRANSDERMAL NDA 18 sections
Androgel HUMAN PRESCRIPTION DRUG LABEL 1 0051-8425 GEL 10 mg TRANSDERMAL NDA 20 sections
Androgel HUMAN PRESCRIPTION DRUG LABEL 1 0051-8450 GEL 10 mg TRANSDERMAL NDA 20 sections
Androgel HUMAN PRESCRIPTION DRUG LABEL 1 0051-8462 GEL 16.20 mg TRANSDERMAL NDA 20 sections
Androgel HUMAN PRESCRIPTION DRUG LABEL 1 0051-8488 GEL 10 mg TRANSDERMAL NDA 20 sections
Vogelxo HUMAN PRESCRIPTION DRUG LABEL 1 0245-0871 GEL 50 mg TOPICAL NDA 22 sections
Vogelxo HUMAN PRESCRIPTION DRUG LABEL 1 0245-0872 GEL, METERED 12.50 mg TOPICAL NDA 22 sections
Testosterone HUMAN PRESCRIPTION DRUG LABEL 1 0254-1012 GEL 50 mg TRANSDERMAL NDA AUTHORIZED GENERIC 20 sections
Testosterone HUMAN PRESCRIPTION DRUG LABEL 1 0591-2114 SOLUTION 30 mg TOPICAL ANDA 20 sections
Testosterone HUMAN PRESCRIPTION DRUG LABEL 1 0591-2363 GEL, METERED 10 mg TOPICAL ANDA 21 sections
Testosterone HUMAN PRESCRIPTION DRUG LABEL 1 0591-2921 GEL 10 mg TOPICAL ANDA 20 sections
Testosterone HUMAN PRESCRIPTION DRUG LABEL 1 0591-2924 GEL 16.20 mg TRANSDERMAL ANDA 20 sections
Testosterone HUMAN PRESCRIPTION DRUG LABEL 1 0591-3216 GEL 10 mg TOPICAL ANDA 20 sections
Testosterone HUMAN PRESCRIPTION DRUG LABEL 1 0591-3217 GEL 10 mg TOPICAL ANDA 20 sections
Testosterone HUMAN PRESCRIPTION DRUG LABEL 1 0591-3524 GEL 50 mg TRANSDERMAL ANDA 20 sections
Testosterone HUMAN PRESCRIPTION DRUG LABEL 1 0603-7831 GEL, METERED 10 mg TOPICAL NDA AUTHORIZED GENERIC 21 sections
Testosterone HUMAN PRESCRIPTION DRUG LABEL 1 0832-1120 GEL 50 mg TOPICAL NDA authorized generic 21 sections
Testosterone HUMAN PRESCRIPTION DRUG LABEL 1 0832-1121 GEL, METERED 12.50 mg TOPICAL NDA authorized generic 21 sections
Testim HUMAN PRESCRIPTION DRUG LABEL 1 16590-853 GEL 50 mg TOPICAL NDA 13 sections
testosterone HUMAN PRESCRIPTION DRUG LABEL 1 16714-967 GEL 20.25 mg TOPICAL ANDA 21 sections
testosterone HUMAN PRESCRIPTION DRUG LABEL 1 16714-968 GEL 20.25 mg TOPICAL ANDA 21 sections
testosterone HUMAN PRESCRIPTION DRUG LABEL 1 16714-969 GEL 40.50 mg TOPICAL ANDA 21 sections
Androgel HUMAN PRESCRIPTION DRUG LABEL 1 21695-112 GEL 10 mg TRANSDERMAL NDA 18 sections
Testosterone HUMAN PRESCRIPTION DRUG LABEL 1 24979-078 GEL 16.20 mg TRANSDERMAL ANDA 19 sections
Testosterone HUMAN PRESCRIPTION DRUG LABEL 1 43598-304 GEL, METERED 1.62 mg TRANSDERMAL ANDA 19 sections
Testopel HUMAN PRESCRIPTION DRUG LABEL 1 43773-1001 PELLET 75 mg SUBCUTANEOUS ANDA 12 sections
testosterone HUMAN PRESCRIPTION DRUG LABEL 1 45802-281 GEL 20.25 mg TOPICAL ANDA 21 sections
testosterone HUMAN PRESCRIPTION DRUG LABEL 1 45802-366 GEL 40.50 mg TOPICAL ANDA 21 sections
testosterone HUMAN PRESCRIPTION DRUG LABEL 1 45802-610 SOLUTION 30 mg TOPICAL ANDA 21 sections