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AboutPricing
Drug ReportsProgesterone
Progesterone
Bijuva, Crinone, Endometrin, Progesterone, Prometrium (progesterone) is a small molecule pharmaceutical. Progesterone was first approved as Progesterone on 1982-01-01. It is used to treat amenorrhea, endometrial hyperplasia, female infertility, and uterine hemorrhage in the USA. The pharmaceutical is active against progesterone receptor. In addition, it is known to target short transient receptor potential channel 5, cation channel sperm-associated protein 1, cation channel sperm-associated protein 4, mineralocorticoid receptor, cation channel sperm-associated protein 2, and cation channel sperm-associated protein 3.
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Clinical
Drug
Target
Variants
Financial
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
urogenital diseasesD000091642
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Crinone, Endometrin, Progesterone, Prometrium (discontinued: Milprosa, Progestasert, Progesterone, Prometrium)
Combinations
Bijuva (discontinued: Estradiol progesterone)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Progesterone
Tradename
Company
Number
Date
Products
CRINONEAbbVieN-020701 RX1997-07-31
2 products, RLD, RS
ENDOMETRINFerring PharmaceuticalsN-022057 RX2007-06-21
1 products, RLD, RS
PROMETRIUMVirtus PharmaceuticalsN-019781 RX1998-05-14
2 products, RLD
Show 5 discontinued
Estradiol
+
Progesterone
Tradename
Company
Number
Date
Products
BIJUVAMayne GroupN-210132 RX2018-10-28
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
advanced formula progesto-lifeunapproved drug other2022-03-31
bijuvaNew Drug Application2025-01-28
crinoneNew Drug Application2024-05-21
endometrinNew Drug Application2022-08-16
estradiol and progesteroneANDA2024-06-07
fluocinolone acetonide 0.01% / minoxidil 7% / progesterone 0.1%unapproved drug other2019-05-08
minoxidil 5% / progesterone 0.1% / tretinoin 0.025%unapproved drug other2019-05-06
minoxidil 7% / progesterone 0.1%unapproved drug other2019-04-24
minoxidil 7% / progesterone 0.1% / tretinoin 0.025%unapproved drug other2019-05-06
p25 progesterone creamunapproved drug other2021-06-21
Show 8 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
uterine hemorrhage—D014592—
amenorrhea—D000568N91.2
endometrial hyperplasia—D004714N85.0
female infertilityEFO_0008560D007247N97
prostatic neoplasms—D011471C61
breast neoplasmsEFO_0003869D001943C50
menorrhagiaEFO_0003945D008595N92.0
primary ovarian insufficiencyEFO_0004266D016649E28.3
hot flashes—D019584—
hypogonadism—D007006E23.0
Show 1 more
Agency Specific
FDA
EMA
Expiration
Code
PROGESTERONE, MILPROSA, FERRING PHARMS INC
2023-04-29NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Estradiol / Progesterone, Bijuva, Mayne Pharma
86331782032-11-21DP
88466482032-11-21U-2439
88466492032-11-21DPU-2439
89330592032-11-21DPU-2439
89872372032-11-21DP
89935482032-11-21DP
89935492032-11-21DP
90062222032-11-21DPU-2439
91141452032-11-21U-2439
91141462032-11-21DPU-2439
93019202032-11-21DPU-2439
100523862032-11-21DP
102069322032-11-21U-2439
106393752032-11-21DP
106752882032-11-21U-2439
108067402032-11-21DPU-2439
110336262032-11-21DPU-2439
111035132032-11-21U-2439
111035162032-11-21DP
111100992032-11-21DP
111669632032-11-21DP
115293602032-11-21DP
Progesterone, Milprosa, Ferring Pharms Inc
85802932030-01-21U-2810
105375842029-02-03DP
105489042029-02-03U-2810
ATC Codes
G: Genito urinary system and sex hormones
— G03: Sex hormones and modulators of the genital system
— G03D: Progestogen sex hormones and modulators of the genital system
— G03DA: Pregnen (4) derivatives, progestogens
— G03DA04: Progesterone
— G03F: Progestogens and estrogens in combination
— G03FA: Progestogens and estrogens, fixed combinations
— G03FA04: Progesterone and estrogen
— G03X: Other sex hormones and modulators of the genital system in atc
— G03XB: Progesterone receptor modulators, sex hormones and modulators of the genital system
HCPCS
Code
Description
J1050
Injection, medroxyprogesterone acetate, 1 mg
J1726
Injection, hydroxyprogesterone caproate, (makena), 10 mg
J1729
Injection, hydroxyprogesterone caproate, not otherwise specified, 10 mg
J2675
Injection, progesterone, per 50 mg
S3620
Newborn metabolic screening panel, includes test kit, postage and the laboratory tests specified by the state for inclusion in this panel (e.g., galactose; hemoglobin, electrophoresis; hydroxyprogesterone, 17-d; phenylalanine (pku); and thyroxine, total)
Clinical
Clinical Trials
1308 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HemostasisD006487———2———2
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PharmacokineticsD010599——1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameProgesterone
INNprogesterone
Description
Progesterone is a C21-steroid hormone in which a pregnane skeleton carries oxo substituents at positions 3 and 20 and is unsaturated at C(4)-C(5). As a hormone, it is involved in the female menstrual cycle, pregnancy and embryogenesis of humans and other species. It has a role as a contraceptive drug, a progestin, a progesterone receptor agonist, a human metabolite and a mouse metabolite. It is a 20-oxo steroid, a 3-oxo-Delta(4) steroid and a C21-steroid hormone. It derives from a hydride of a pregnane.
Classification
Small molecule
Drug classprogestins; steroids (androgens, anabolics); antiandrogens
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(=O)[C@H]1CC[C@H]2[C@@H]3CCC4=CC(=O)CC[C@]4(C)[C@H]3CC[C@]12C
Identifiers
PDB—
CAS-ID57-83-0
RxCUI—
ChEMBL IDCHEMBL103
ChEBI ID17026
PubChem CID5994
DrugBankDB00396
UNII ID4G7DS2Q64Y (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
NR3C2
NR3C2
CATSPER2
CATSPER2
NCOA2
NCOA2
Organism
Homo sapiens
Gene name
NR3C2
Gene synonyms
MCR, MLR
NCBI Gene ID
4306
Protein name
mineralocorticoid receptor
Protein synonyms
aldosterone receptor, mineralocorticoid receptor 1, mineralocorticoid receptor 2, mineralocorticoid receptor delta, Nuclear receptor subfamily 3 group C member 2
Uniprot ID
Q96KQ9
Mouse ortholog
Nr3c2 (110784)
mineralocorticoid receptor (Q8VII8)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Crinone – Juniper Pharmaceuticals
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Bijuva – TherapeuticsMD
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Estimated US medical usage
Progesterone
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 87,117 documents
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Safety
Black-box Warning
Black-box warning for: Bijuva, Estradiol and progesterone, Progesterone, Prometrium
Adverse Events
Top Adverse Reactions
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50,496 adverse events reported
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