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

Stem definitionDrug idCAS RN
steroids, progestogens 2279 57-83-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • progesterone
  • gestone
  • gestormone
  • glanducorpin
  • lugesteron
  • lugesterone
  • progestan
  • progeston
  • progestone
  • progestron
  • progesterol
  • syngesterone
The major progestational steroid that is secreted primarily by the CORPUS LUTEUM and the PLACENTA. Progesterone acts on the UTERUS, the MAMMARY GLANDS and the BRAIN. It is required in EMBRYO IMPLANTATION; PREGNANCY maintenance, and the development of mammary tissue for MILK production. Progesterone, converted from PREGNENOLONE, also serves as an intermediate in the biosynthesis of GONADAL STEROID HORMONES and adrenal CORTICOSTEROIDS.
  • Molecular weight: 314.47
  • Formula: C21H30O2
  • CLOGP: 3.96
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 0
  • TPSA: 34.14
  • ALOGS: -4.76
  • ROTB: 1

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.30 g O
5 mg P
0.20 g R
90 mg V

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.01 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 21.20 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 25 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Feb. 4, 1976 FDA ALZA
Sept. 27, 2021 PMDA FUJI PHARMA CO., LTD.

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
Ovarian hyperstimulation syndrome 668.58 12.39 178 22913 3403 53322572
Temperature regulation disorder 384.70 12.39 120 22971 4087 53321888
Food allergy 313.14 12.39 122 22969 8096 53317879
Coeliac disease 305.92 12.39 122 22969 8613 53317362
Exposure during pregnancy 249.11 12.39 288 22803 124572 53201403
Immunodeficiency 234.13 12.39 119 22972 14848 53311127
Maternal exposure during pregnancy 215.14 12.39 299 22792 155340 53170635
Bursitis 209.23 12.39 127 22964 22365 53303610
Abortion spontaneous 189.77 12.39 159 22932 46476 53279499
Premature labour 161.11 12.39 87 23004 12275 53313700
Foetal exposure during pregnancy 152.99 12.39 124 22967 34591 53291384
Rash erythematous 152.47 12.39 128 22963 37495 53288480
Product adhesion issue 152.46 12.39 65 23026 5432 53320543
Premature delivery 142.80 12.39 106 22985 25998 53299977
Fluid retention 128.08 12.39 137 22954 54264 53271711
Hyperhidrosis 118.90 12.39 176 22915 96617 53229358
Meningioma 109.58 12.39 46 23045 3698 53322277
Upper respiratory tract infection 106.27 12.39 140 22951 68957 53257018
Death 94.11 12.39 20 23071 357212 52968763
Vaginal haemorrhage 91.93 12.39 83 23008 26758 53299217
Autoimmune dermatitis 87.91 12.39 16 23075 40 53325935
Premature baby 87.78 12.39 71 23020 19730 53306245
Gestational diabetes 86.78 12.39 50 23041 7989 53317986
Hot flush 84.28 12.39 103 22988 47057 53278918
Butterfly rash 82.35 12.39 27 23064 1080 53324895
Postmenopausal haemorrhage 81.63 12.39 32 23059 2155 53323820
Headache 79.50 12.39 448 22643 536373 52789602
Oligohydramnios 74.27 12.39 41 23050 6035 53319940
Pregnancy 71.89 12.39 78 23013 31363 53294612
Erythema 69.57 12.39 186 22905 156783 53169192
Premature rupture of membranes 67.81 12.39 36 23055 4904 53321071
Haemorrhage in pregnancy 62.44 12.39 25 23066 1780 53324195
Off label use 61.98 12.39 382 22709 471830 52854145
Asthma 61.87 12.39 142 22949 108830 53217145
Placenta accreta 61.27 12.39 15 23076 201 53325774
Maternal exposure before pregnancy 60.40 12.39 35 23056 5651 53320324
Toxicity to various agents 58.36 12.39 12 23079 219586 53106389
Progesterone decreased 56.85 12.39 13 23078 127 53325848
Pre-eclampsia 56.18 12.39 39 23052 8608 53317367
Ectopic pregnancy 55.05 12.39 26 23065 2761 53323214
Normal newborn 52.89 12.39 35 23056 7144 53318831
Hepatic enzyme increased 51.37 12.39 145 22946 126050 53199925
Acute kidney injury 51.08 12.39 23 23068 253845 53072130
Constipation 48.60 12.39 192 22899 198220 53127755
Pneumonia 46.67 12.39 65 23026 407104 52918871
Breast hyperplasia 43.23 12.39 12 23079 269 53325706
Small for dates baby 42.27 12.39 24 23067 3728 53322247
Drug hypersensitivity 42.15 12.39 226 22865 265016 53060959
Periorbital oedema 41.81 12.39 27 23064 5288 53320687
Abortion threatened 41.46 12.39 14 23077 614 53325361
Vulvovaginal discomfort 40.93 12.39 20 23071 2289 53323686
Hypersensitivity 40.15 12.39 189 22902 210476 53115499
Human herpesvirus 6 infection 39.20 12.39 20 23071 2510 53323465
Head discomfort 37.79 12.39 35 23056 11649 53314326
Hormone level abnormal 37.17 12.39 19 23072 2394 53323581
Ophthalmic vein thrombosis 36.60 12.39 9 23082 123 53325852
Uterine haemorrhage 36.25 12.39 22 23069 3865 53322110
Photosensitivity reaction 34.60 12.39 36 23055 13792 53312183
Foetal death 34.17 12.39 30 23061 9317 53316658
Back pain 33.46 12.39 194 22897 234053 53091922
Suicidal behaviour 33.31 12.39 18 23073 2540 53323435
Systemic lupus erythematosus 32.99 12.39 7 23084 125407 53200568
Tinnitus 32.50 12.39 52 23039 30467 53295508
Foetal growth restriction 32.37 12.39 26 23065 7148 53318827
Ascites 32.21 12.39 60 23031 39675 53286300
Completed suicide 31.98 12.39 10 23081 138191 53187784
Intermenstrual bleeding 31.96 12.39 28 23063 8670 53317305
Product odour abnormal 31.86 12.39 14 23077 1258 53324717
Endometrial stromal sarcoma 31.46 12.39 6 23085 21 53325954
Adnexal torsion 30.25 12.39 9 23082 260 53325715
Glossodynia 29.91 12.39 4 23087 100287 53225688
Neutropenia 29.60 12.39 16 23075 159169 53166806
Blood oestrogen decreased 29.52 12.39 9 23082 283 53325692
Atrial septal defect 28.97 12.39 24 23067 6890 53319085
Wound 28.92 12.39 3 23088 91554 53234421
Product use issue 28.62 12.39 128 22963 139456 53186519
Vaginal discharge 28.43 12.39 22 23069 5731 53320244
Periodic limb movement disorder 27.65 12.39 8 23083 209 53325766
Product use in unapproved indication 26.91 12.39 108 22983 112181 53213794
Sepsis 26.81 12.39 15 23076 146414 53179561
Congenital absence of vertebra 26.80 12.39 5 23086 15 53325960
Product quality issue 26.45 12.39 53 23038 36970 53289005
Synovitis 26.45 12.39 7 23084 107886 53218089
Breast tenderness 26.41 12.39 15 23076 2331 53323644
Ovarian enlargement 26.26 12.39 9 23082 413 53325562
Anxiety 26.20 12.39 160 22931 196544 53129431
Twin pregnancy 25.74 12.39 12 23079 1237 53324738
Cardiac arrest 25.11 12.39 5 23086 93662 53232313
Caesarean section 24.92 12.39 34 23057 17286 53308689
Retained placenta or membranes 24.81 12.39 8 23083 303 53325672
Abortion missed 24.78 12.39 13 23078 1728 53324247
Pelvic infection 24.69 12.39 8 23083 308 53325667
Hippocampal sclerosis 24.07 12.39 6 23085 87 53325888
Talipes 23.64 12.39 12 23079 1490 53324485
Febrile neutropenia 23.56 12.39 8 23083 104928 53221047
Patent ductus arteriosus 23.13 12.39 17 23074 4101 53321874
Treatment failure 22.31 12.39 14 23077 128389 53197586
Anaemia 22.06 12.39 55 23036 276663 53049312
Application site erythema 22.02 12.39 18 23073 5073 53320902
Decreased appetite 21.99 12.39 37 23054 214937 53111038
Preterm premature rupture of membranes 21.93 12.39 11 23080 1332 53324643
Subchorionic haematoma 21.47 12.39 6 23085 138 53325837
Drug intolerance 21.36 12.39 35 23056 205458 53120517
Retroplacental haematoma 20.84 12.39 6 23085 154 53325821
Endometrial hyperplasia 20.81 12.39 9 23082 778 53325197
Application site pruritus 20.79 12.39 16 23075 4133 53321842
Carnitine deficiency 20.69 12.39 6 23085 158 53325817
Ovarian cyst 20.51 12.39 29 23062 15240 53310735
Renal failure 20.46 12.39 13 23078 118439 53207536
Ovarian haemorrhage 20.35 12.39 7 23084 325 53325650
Complication of pregnancy 20.12 12.39 8 23083 559 53325416
Menopausal symptoms 19.98 12.39 12 23079 2069 53323906
Ultrasound liver abnormal 19.82 12.39 4 23087 20 53325955
Application site rash 19.51 12.39 13 23078 2683 53323292
Live birth 19.34 12.39 28 23063 15031 53310944
Renal impairment 19.32 12.39 6 23085 83312 53242663
Oestradiol increased 19.26 12.39 5 23086 86 53325889
Temporal lobe epilepsy 19.16 12.39 7 23084 388 53325587
Eosinophilic pneumonia acute 18.58 12.39 7 23084 423 53325552
Hypogonadism 18.50 12.39 5 23086 101 53325874
Cardiac failure 18.49 12.39 7 23084 85837 53240138
Confusional state 18.45 12.39 35 23056 194186 53131789
Abdominal discomfort 18.35 12.39 43 23048 221019 53104956
Uterine haematoma 17.89 12.39 4 23087 35 53325940
Therapeutic response unexpected 17.80 12.39 29 23062 17241 53308734
Arthropathy 17.79 12.39 21 23070 141432 53184543
Blister 17.68 12.39 6 23085 78747 53247228
Hypotension 17.63 12.39 54 23037 254022 53071953
Congenital umbilical hernia 17.59 12.39 7 23084 490 53325485
Turner's syndrome 17.38 12.39 5 23086 128 53325847
Breast enlargement 17.37 12.39 10 23081 1594 53324381
Product taste abnormal 17.28 12.39 11 23080 2102 53323873
Cholestasis of pregnancy 17.13 12.39 9 23082 1200 53324775
Abdominal pain lower 17.12 12.39 34 23057 23559 53302416
Enlarged clitoris 16.72 12.39 5 23086 147 53325828
Gastrointestinal haemorrhage 16.57 12.39 7 23084 80323 53245652
Drug abuse 16.54 12.39 4 23087 65522 53260453
Biochemical pregnancy 16.34 12.39 3 23088 8 53325967
Cardiac failure congestive 16.27 12.39 10 23081 92747 53233228
Feeling hot 16.16 12.39 47 23044 41497 53284478
Abortion 16.14 12.39 11 23080 2355 53323620
Vomiting 16.01 12.39 138 22953 497001 52828974
Swelling 16.00 12.39 37 23054 191068 53134907
Application site irritation 15.98 12.39 10 23081 1854 53324121
Interstitial lung disease 15.98 12.39 3 23088 58619 53267356
Premature separation of placenta 15.97 12.39 10 23081 1857 53324118
Primary hypogonadism 15.91 12.39 5 23086 174 53325801
Hydrops foetalis 15.90 12.39 6 23085 364 53325611
Uterine leiomyoma 15.50 12.39 19 23072 8693 53317282
Urinary tract discomfort 15.34 12.39 5 23086 196 53325779
Keratoconus 15.22 12.39 3 23088 13 53325962
Multiple-drug resistance 15.18 12.39 12 23079 3223 53322752
Fall 15.15 12.39 92 22999 358348 52967627
Malignant neoplasm progression 15.13 12.39 6 23085 71535 53254440
Drug exposure before pregnancy 15.10 12.39 7 23084 713 53325262
Retinal vein occlusion 14.94 12.39 10 23081 2078 53323897
Arterial intramural haematoma 14.87 12.39 3 23088 15 53325960
Ovarian cyst ruptured 14.63 12.39 8 23083 1156 53324819
Haemoglobin decreased 14.63 12.39 23 23068 137284 53188691
Endometrial cancer stage I 14.60 12.39 5 23086 229 53325746
Foreign body in reproductive tract 14.57 12.39 6 23085 459 53325516
Erythema nodosum 14.54 12.39 13 23078 4132 53321843
Subdural hygroma 14.45 12.39 5 23086 236 53325739
General physical health deterioration 14.37 12.39 26 23065 146916 53179059
Lower respiratory tract infection 14.37 12.39 11 23080 90970 53235005
Hyperkalaemia 14.32 12.39 3 23088 54253 53271722
Heterotopic pregnancy 14.27 12.39 3 23088 19 53325956
Pulmonary oedema 14.12 12.39 3 23088 53720 53272255
Cardio-respiratory arrest 14.04 12.39 4 23087 58754 53267221
Night sweats 14.04 12.39 40 23051 34907 53291068
Abdominal distension 14.02 12.39 70 23021 79720 53246255
Foetal hypokinesia 14.00 12.39 6 23085 507 53325468
Anti-Muellerian hormone level decreased 13.99 12.39 4 23087 100 53325875
Gastroschisis 13.94 12.39 5 23086 263 53325712
Prescribed overdose 13.92 12.39 23 23068 13836 53312139
Dyspnoea 13.86 12.39 175 22916 586057 52739918
Product physical issue 13.70 12.39 14 23077 5248 53320727
Chorioretinopathy 13.66 12.39 7 23084 886 53325089
Application site urticaria 13.53 12.39 5 23086 286 53325689
Blood oestrogen increased 13.53 12.39 4 23087 113 53325862
Liver tenderness 13.50 12.39 4 23087 114 53325861
Peripheral swelling 13.46 12.39 45 23046 206063 53119912
Idiopathic angioedema 13.44 12.39 3 23088 26 53325949
Fatigue 13.44 12.39 412 22679 730094 52595881
Uterine polyp 13.39 12.39 9 23082 1884 53324091
Placental insufficiency 13.38 12.39 8 23083 1368 53324607
Pyrexia 13.38 12.39 111 22980 403082 52922893
Postpartum haemorrhage 13.31 12.39 9 23082 1903 53324072
Diarrhoea 13.25 12.39 191 22900 625355 52700620
Thrombocytopenia 13.17 12.39 25 23066 138702 53187273
Injection site pain 13.09 12.39 89 23002 113302 53212673
Embedded device 13.06 12.39 11 23080 3230 53322745
Dehydration 13.00 12.39 34 23057 168376 53157599
Disease progression 12.95 12.39 15 23076 101905 53224070
Product substitution issue 12.91 12.39 24 23067 15842 53310133
Swelling face 12.90 12.39 54 23037 57114 53268861
Aura 12.86 12.39 7 23084 1002 53324973
Meningioma benign 12.72 12.39 5 23086 339 53325636
Cervical incompetence 12.70 12.39 6 23085 637 53325338
Respiratory failure 12.55 12.39 15 23076 100497 53225478
Delayed delivery 12.41 12.39 3 23088 38 53325937

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
Foetal exposure during pregnancy 658.23 113.84 161 707 41140 32471518
Premature baby 295.24 113.84 73 795 18445 32494213

Pharmacologic Action:

SourceCodeDescription
ATC G03DA04 GENITO URINARY SYSTEM AND SEX HORMONES
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
PROGESTOGENS
Pregnen (4) derivatives
ATC G03FA04 GENITO URINARY SYSTEM AND SEX HORMONES
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
PROGESTOGENS AND ESTROGENS IN COMBINATION
Progestogens and estrogens, fixed combinations
FDA CS M0017672 Progesterone
FDA EPC N0000175601 Progesterone
MeSH PA D009465 Neuromuscular Agents
MeSH PA D009466 Neuromuscular Blocking Agents
MeSH PA D003473 Neuromuscular Nondepolarizing Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D006728 Hormones
MeSH PA D011372 Progestins
CHEBI has role CHEBI:49323 contraceptive agent
CHEBI has role CHEBI:59826 progestins
CHEBI has role CHEBI:70709 PR agonists
CHEBI has role CHEBI:75771 Mus musculus metabolite
CHEBI has role CHEBI:77746 H. sapiens metabolites

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Contraception indication 13197004
Dysfunctional uterine bleeding indication 19155002
Atrophic vaginitis indication 52441000
Secondary physiologic amenorrhea indication 86030004
Secondary malignant neoplasm of kidney indication 94360002
Postmenopausal osteoporosis indication 102447009
Endometriosis indication 129103003
Menopausal flushing indication 198436008
Endometrial carcinoma indication 254878006 DOID:2871
Amenorrhea Secondary to Ovarian Dysfunction indication
Corpus Luteum Insufficiency Syndrome indication
Prevention of Premature Labor indication
Infertility Secondary to Progesterone Deficiency indication
Endometrial Hyperplasia Prevention indication
Polycystic ovaries off-label use 69878008
Menorrhagia off-label use 386692008
Precocious puberty off-label use 400179000
Endogenous Estrogen Production Test off-label use
Female Hormonal Imbalance off-label use
Hyperlipoproteinemia contraindication 3744001 DOID:1168
Hypocalcemia contraindication 5291005
Alcoholism contraindication 7200002
Weight gain finding contraindication 8943002
Impaired glucose tolerance contraindication 9414007
Hypercholesterolemia contraindication 13644009
Jaundice contraindication 18165001
Myocardial infarction contraindication 22298006 DOID:5844
Fibroadenosis of breast contraindication 23260002 DOID:10352
Diplopia contraindication 24982008
Retinal hemorrhage contraindication 28998008
Ectopic pregnancy contraindication 34801009 DOID:0060329
Depressive disorder contraindication 35489007
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
Mild pre-eclampsia contraindication 41114007
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
Hyperlipidemia contraindication 55822004 DOID:1168
Anorexia nervosa contraindication 56882008 DOID:8689
Hepatic failure contraindication 59927004
Cerebrovascular disease contraindication 62914000 DOID:6713
Thrombophlebitis contraindication 64156001 DOID:3875
Osteoporosis contraindication 64859006 DOID:11476
Intermenstrual bleeding - irregular contraindication 64996003
Diabetes mellitus contraindication 73211009 DOID:9351
Hyperglycemia contraindication 80394007 DOID:4195
Epilepsy contraindication 84757009 DOID:1826
Breast lump contraindication 89164003
Kidney disease contraindication 90708001 DOID:557
Malignant neoplasm of liver contraindication 93870000 DOID:3571
Uterine leiomyoma contraindication 95315005 DOID:13223
Neoplasm of liver contraindication 126851005 DOID:3571
Deep venous thrombosis contraindication 128053003
Seizure disorder contraindication 128613002
Incomplete miscarriage contraindication 156072005
Bed-ridden contraindication 160685001
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
Chorea contraindication 271700006
Pregnancy, function contraindication 289908002
Hypertriglyceridemia contraindication 302870006
Osteopenia contraindication 312894000
Functional visual loss contraindication 313165001
Malignant tumor of ovary contraindication 363443007 DOID:2394
Thromboembolic disorder contraindication 371039008
Cardiovascular event risk contraindication 395112001
Disorder of coronary artery contraindication 414024009
Obesity contraindication 414916001 DOID:9970
Estrogen receptor positive tumor contraindication 416053008
Porphyria contraindication 418470004
Optic disc edema contraindication 423341008 DOID:146
Family history of malignant neoplasm of breast contraindication 429740004
Hypertensive urgency contraindication 443482000
Carcinoma of female breast contraindication 447782002
Smokes tobacco daily contraindication 449868002
Predisposition to Thrombosis 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
1.78GM MILPROSA FERRING PHARMS INC N201110 April 29, 2020 DISCN SYSTEM VAGINAL 10548904 Feb. 3, 2029 METHOD OF SUPPORTING EMBRYO IMPLANTATION AND EARLY PREGNANCY BY SUPPLEMENTATION OF CORPUS LUTEAL FUNCTION AS PART OF AN ASSISTED REPRODUCTIVE TECHNOLOGY (ART) TREATMENT PROGRAM FOR INFERTILE WOMEN
1.78GM MILPROSA FERRING PHARMS INC N201110 April 29, 2020 DISCN SYSTEM VAGINAL 8580293 Jan. 21, 2030 METHOD OF SUPPORTING EMBRYO IMPLANTATION AND EARLY PREGNANCY BY SUPPLEMENTATION OF CORPUS LUTEAL FUNCTION AS PART OF AN ASSISTED REPRODUCTIVE TECHNOLOGY (ART) TREATMENT PROGRAM FOR INFERTILE WOMEN
0.5MG;100MG BIJUVA THERAPEUTICSMD INC N210132 Dec. 28, 2021 RX CAPSULE ORAL 10206932 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG BIJUVA THERAPEUTICSMD INC N210132 Dec. 28, 2021 RX CAPSULE ORAL 10675288 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG BIJUVA THERAPEUTICSMD INC N210132 Dec. 28, 2021 RX CAPSULE ORAL 11033626 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG BIJUVA THERAPEUTICSMD INC N210132 Dec. 28, 2021 RX CAPSULE ORAL 8846648 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG BIJUVA THERAPEUTICSMD INC N210132 Dec. 28, 2021 RX CAPSULE ORAL 8846649 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG BIJUVA THERAPEUTICSMD INC N210132 Dec. 28, 2021 RX CAPSULE ORAL 8933059 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG BIJUVA THERAPEUTICSMD INC N210132 Dec. 28, 2021 RX CAPSULE ORAL 9114145 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG BIJUVA THERAPEUTICSMD INC N210132 Dec. 28, 2021 RX CAPSULE ORAL 9114146 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG BIJUVA THERAPEUTICSMD INC N210132 Dec. 28, 2021 RX CAPSULE ORAL 9301920 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG BIJUVA THERAPEUTICSMD INC N210132 Oct. 28, 2018 RX CAPSULE ORAL 10206932 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG BIJUVA THERAPEUTICSMD INC N210132 Oct. 28, 2018 RX CAPSULE ORAL 10675288 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG BIJUVA THERAPEUTICSMD INC N210132 Oct. 28, 2018 RX CAPSULE ORAL 10806740 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG BIJUVA THERAPEUTICSMD INC N210132 Oct. 28, 2018 RX CAPSULE ORAL 11033626 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG BIJUVA THERAPEUTICSMD INC N210132 Oct. 28, 2018 RX CAPSULE ORAL 11103513 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG BIJUVA THERAPEUTICSMD INC N210132 Oct. 28, 2018 RX CAPSULE ORAL 8846648 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG BIJUVA THERAPEUTICSMD INC N210132 Oct. 28, 2018 RX CAPSULE ORAL 8846649 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG BIJUVA THERAPEUTICSMD INC N210132 Oct. 28, 2018 RX CAPSULE ORAL 9006222 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG BIJUVA THERAPEUTICSMD INC N210132 Oct. 28, 2018 RX CAPSULE ORAL 9114145 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG BIJUVA THERAPEUTICSMD INC N210132 Oct. 28, 2018 RX CAPSULE ORAL 9114146 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG BIJUVA THERAPEUTICSMD INC N210132 Oct. 28, 2018 RX CAPSULE ORAL 9301920 Nov. 21, 2032 TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
1.78GM MILPROSA FERRING PHARMS INC N201110 April 29, 2020 DISCN SYSTEM VAGINAL April 29, 2023 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Progesterone receptor Nuclear hormone receptor AGONIST ED50 9.88 WOMBAT-PK CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 6.59 CHEMBL
Multidrug resistance protein 1 Transporter IC50 4.32 CHEMBL
Glucocorticoid receptor Nuclear hormone receptor Ki 7.52 CHEMBL
Mineralocorticoid receptor Nuclear hormone receptor EC50 11 WOMBAT-PK
Estrogen receptor Nuclear hormone receptor WOMBAT-PK
Androgen receptor Nuclear hormone receptor Ki 8.07 CHEMBL
Corticosteroid-binding globulin Secreted Ki 7.38 CHEMBL
Sex hormone-binding globulin Secreted Kd 6.94 CHEMBL
Sterol O-acyltransferase 1 Enzyme IC50 4.77 CHEMBL
Fatty acid-binding protein, intestinal Cytosolic other Ki 4.70 CHEMBL
Cation channel sperm-associated protein 1 Ion channel ACTIVATOR EC50 8.11 IUPHAR
Cation channel sperm-associated protein 2 Ion channel ACTIVATOR EC50 8.11 IUPHAR
Cation channel sperm-associated protein 3 Ion channel ACTIVATOR EC50 8.11 IUPHAR
Cation channel sperm-associated protein 4 Ion channel ACTIVATOR EC50 8.11 IUPHAR
Short transient receptor potential channel 5 Ion channel BLOCKER IC50 5.30 IUPHAR
Sodium/nucleoside cotransporter 1 Transporter Ki 5.17 DRUG MATRIX
P2X purinoceptor 3 Ion channel IC50 5.80 CHEMBL
Androgen receptor Transcription factor IC50 5.81 CHEMBL
Fatty acid-binding protein, liver Unclassified Ki 7.57 CHEMBL
Progesterone receptor Transcription factor Ki 8.44 DRUG MATRIX
Sigma non-opioid intracellular receptor 1 Membrane receptor Kd 6.62 CHEMBL
Androgen receptor Transcription factor IC50 7.43 CHEMBL
Progesterone receptor Transcription factor Ki 7.98 CHEMBL
C-8 sterol isomerase Enzyme Ki 5.35 CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane other Ki 6.18 CHEMBL
Steroid 5-alpha-reductase Enzyme IC50 5.80 CHEMBL
Estrogen receptor Transcription factor Kd 8.41 CHEMBL

External reference:

IDSource
4017453 VUID
N0000145841 NUI
D00066 KEGG_DRUG
4017453 VANDF
C0033308 UMLSCUI
CHEBI:17026 CHEBI
STR PDB_CHEM_ID
CHEMBL103 ChEMBL_ID
DB00396 DRUGBANK_ID
D011374 MESH_DESCRIPTOR_UI
5994 PUBCHEM_CID
2377 IUPHAR_LIGAND_ID
C003549 MESH_SUPPLEMENTAL_RECORD_UI
417 INN_ID
4G7DS2Q64Y UNII
8727 RXNORM
2110 MMSL
53089 MMSL
5365 MMSL
d00550 MMSL
001290 NDDF
16683002 SNOMEDCT_US
50318003 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Crinone HUMAN PRESCRIPTION DRUG LABEL 1 0023-6150 GEL 45 mg VAGINAL NDA 23 sections
Crinone HUMAN PRESCRIPTION DRUG LABEL 1 0023-6151 GEL 90 mg VAGINAL NDA 23 sections
Progesterone HUMAN PRESCRIPTION DRUG LABEL 1 0143-9725 INJECTION 50 mg INTRAMUSCULAR ANDA 13 sections
PROGESTERONE HUMAN PRESCRIPTION DRUG LABEL 1 0591-3128 INJECTION, SOLUTION 50 mg INTRAMUSCULAR NDA 13 sections
PROGESTERONE Human Prescription Drug Label 1 10888-7135 CAPSULE 100 mg ORAL ANDA 21 sections
PROGESTERONE Human Prescription Drug Label 1 10888-7136 CAPSULE 200 mg ORAL ANDA 21 sections
Progesterone HUMAN PRESCRIPTION DRUG LABEL 1 16714-157 CAPSULE 100 mg ORAL ANDA 25 sections
Progesterone HUMAN PRESCRIPTION DRUG LABEL 1 16714-158 CAPSULE 200 mg ORAL ANDA 25 sections
Progesterone HUMAN PRESCRIPTION DRUG LABEL 1 17478-766 CAPSULE 100 mg ORAL ANDA 23 sections
Progesterone HUMAN PRESCRIPTION DRUG LABEL 1 17478-767 CAPSULE 200 mg ORAL ANDA 23 sections
Progesterone HUMAN PRESCRIPTION DRUG LABEL 1 43598-349 CAPSULE 100 mg ORAL ANDA 21 sections
Progesterone HUMAN PRESCRIPTION DRUG LABEL 1 43598-350 CAPSULE 200 mg ORAL ANDA 21 sections
Progesterone HUMAN PRESCRIPTION DRUG LABEL 1 50090-2527 CAPSULE 100 mg ORAL ANDA 23 sections
Progesterone HUMAN PRESCRIPTION DRUG LABEL 1 50090-3240 CAPSULE 100 mg ORAL NDA 24 sections
Progesterone HUMAN PRESCRIPTION DRUG LABEL 1 50090-4656 CAPSULE 100 mg ORAL ANDA 23 sections
Bijuva HUMAN PRESCRIPTION DRUG LABEL 2 50261-211 CAPSULE 100 mg ORAL NDA 33 sections
Progesterone HUMAN PRESCRIPTION DRUG LABEL 1 53002-1760 CAPSULE 200 mg ORAL ANDA 23 sections
Prometrium HUMAN PRESCRIPTION DRUG LABEL 1 54868-4230 CAPSULE 200 mg ORAL NDA 15 sections
Prometrium HUMAN PRESCRIPTION DRUG LABEL 1 54868-4250 CAPSULE 100 mg ORAL NDA 15 sections
Prochieve HUMAN PRESCRIPTION DRUG LABEL 1 55056-0406 GEL 45 mg VAGINAL NDA 24 sections
Crinone HUMAN PRESCRIPTION DRUG LABEL 1 55056-0806 GEL 90 mg VAGINAL NDA 24 sections
Crinone HUMAN PRESCRIPTION DRUG LABEL 1 55056-0808 GEL 45 mg VAGINAL NDA 24 sections
Crinone HUMAN PRESCRIPTION DRUG LABEL 1 55056-0818 GEL 90 mg VAGINAL NDA 24 sections
Prochieve HUMAN PRESCRIPTION DRUG LABEL 1 55056-1601 GEL 90 mg VAGINAL NDA 24 sections
Progesterone Human Prescription Drug Label 1 55150-306 INJECTION, SOLUTION 50 mg INTRAMUSCULAR ANDA 16 sections
ENDOMETRIN HUMAN PRESCRIPTION DRUG LABEL 1 55566-6500 INSERT 100 mg VAGINAL NDA 26 sections
Ferring Pharmaceuticals Inc. HUMAN PRESCRIPTION DRUG LABEL 1 55566-9400 RING 11 mg VAGINAL NDA 28 sections
Progesterone Human Prescription Drug Label 1 59651-152 CAPSULE 100 mg ORAL ANDA 22 sections
Progesterone Human Prescription Drug Label 1 59651-153 CAPSULE 200 mg ORAL ANDA 22 sections
Progesterone HUMAN PRESCRIPTION DRUG LABEL 1 60429-868 CAPSULE 100 mg ORAL ANDA 21 sections