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AboutPricing
Drug ReportsMedroxyprogesterone
Medroxyprogesterone acetate
Lunelle, Medroxyprogesterone, Premphase, Prempro, Provera (medroxyprogesterone acetate) is a small molecule pharmaceutical. Medroxyprogesterone acetate was first approved as Provera on 1982-01-01. It is used to treat amenorrhea, breast neoplasms, endometrial hyperplasia, endometrial neoplasms, and hypoventilation amongst others in the USA. The pharmaceutical is active against progesterone receptor.
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Events Timeline
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
respiratory tract diseasesD012140
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Depo-provera, Depo-subq provera, Medroxyprogesterone, Provera (discontinued: Amen, Curretab, Depo-provera, Medroxyprogesterone)
Combinations
Prempro (discontinued: Lunelle, Premphase (premarin;cycrin ))
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Medroxyprogesterone acetate
Tradename
Company
Number
Date
Products
DEPO-PROVERAPfizerN-020246 RX1992-10-29
1 products, RLD, RS
DEPO-SUBQ PROVERA 104PfizerN-021583 RX2004-12-17
1 products, RLD, RS
PROVERAPfizerN-011839 RX1982-01-01
3 products, RLD, RS
Show 1 discontinued
Estradiol cypionate
+
Medroxyprogesterone acetate
Tradename
Company
Number
Date
Products
LUNELLEPharmacia & UpjohnN-020874 DISCN2000-10-05
1 products, RLD
Hide discontinued
Estrogens
+
conjugated
+
Medroxyprogesterone acetate
Tradename
Company
Number
Date
Products
PREMPROWyethN-020527 RX1995-11-17
1 products, RLD, RS
PREMPHASE 14/14WyethN-020527 RX1995-11-17
1 products, RLD, RS
PREMPROWyethN-020527 RX1998-01-09
3 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
depo-proveraNew Drug Application2024-07-26
depo-subq proveraNew Drug Application2024-12-26
depo-subq provera 1042006-05-23
medroxyprogesteroneANDA2022-10-09
medroxyprogesterone acetateANDA2025-01-30
medroxyprogesterone acetate injectable suspensionANDA2025-01-08
premphaseANDA2012-11-26
premphase premproNew Drug Application2024-12-19
premproNew Drug Application2021-02-05
proveraNew Drug Application2024-08-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
renal cell carcinomaEFO_0000376D002292—
breast neoplasmsEFO_0003869D001943C50
endometrial neoplasmsEFO_0004230D016889—
uterine hemorrhage—D014592—
amenorrhea—D000568N91.2
endometrial hyperplasia—D004714N85.0
hypoventilation—D007040—
prostatic neoplasms—D011471C61
menorrhagiaEFO_0003945D008595N92.0
primary ovarian insufficiencyEFO_0004266D016649E28.3
Show 3 more
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
G: Genito urinary system and sex hormones
— G03: Sex hormones and modulators of the genital system
— G03A: Hormonal contraceptives for systemic use
— G03AA: Progestogens and estrogen systemic contraceptives, fixed combinations
— G03AA08: Medroxyprogesterone and ethinylestradiol
— G03AA17: Medroxyprogesterone and estradiol
— G03AC: Progestogen systemic hormonal contraceptives
— G03AC06: Medroxyprogesterone
— G03D: Progestogen sex hormones and modulators of the genital system
— G03DA: Pregnen (4) derivatives, progestogens
— G03DA02: Medroxyprogesterone
— G03F: Progestogens and estrogens in combination
— G03FA: Progestogens and estrogens, fixed combinations
— G03FA12: Medroxyprogesterone and estrogen
— G03FB: Progestogens and estrogens, sequential preparations
— G03FB06: Medroxyprogesterone and estrogen
L: Antineoplastic and immunomodulating agents
— L02: Endocrine therapy antineoplastic and immunomodulating agents
— L02A: Hormones and related agents
— L02AB: Progestogens, endocrine therapy drugs
— L02AB02: Medroxyprogesterone
HCPCS
Code
Description
J1050
Injection, medroxyprogesterone acetate, 1 mg
Clinical
Clinical Trials
226 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ContraceptionD003267——3————3
PregnancyD011247EFO_0002950Z33.11————1
Healthy volunteers/patients———1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMedroxyprogesterone acetate
INNmedroxyprogesterone
Description
Medroxyprogesterone acetate is an acetate ester resulting from the formal condensation of the 17alpha-hydroxy group of medroxyprogesterone with the carboxy group of acetic acid. A widely used progestin in menopausal hormone therapy and in progestogen-only birth control. It has a role as a progestin, an androgen, a female contraceptive drug, a synthetic oral contraceptive, an adjuvant, an inhibitor, an antioxidant and an antineoplastic agent. It is a steroid ester, an acetate ester, a 20-oxo steroid, a 3-oxo-Delta(4) steroid and a corticosteroid. It is functionally related to a medroxyprogesterone.
Classification
Small molecule
Drug classprogestins; steroids (androgens, anabolics); antiandrogens
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(=O)O[C@]1(C(C)=O)CC[C@H]2[C@@H]3C[C@H](C)C4=CC(=O)CC[C@]4(C)[C@H]3CC[C@@]21C
Identifiers
PDB—
CAS-ID71-58-9
RxCUI—
ChEMBL IDCHEMBL717
ChEBI ID6716
PubChem CID6279
DrugBankDB00603
UNII IDHSU1C9YRES (ChemIDplus, GSRS)
Target
Agency Approved
PGR
PGR
Organism
Homo sapiens
Gene name
PGR
Gene synonyms
NR3C3
NCBI Gene ID
5241
Protein name
progesterone receptor
Protein synonyms
Nuclear receptor subfamily 3 group C member 3
Uniprot ID
Q9UPF7
Mouse ortholog
Pgr (18667)
progesterone receptor (Q00175)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Provera – Pfizer
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Tabular view
Estimated US medical usage
Medroxyprogesterone acetate
+
Estradiol
+
Medroxyprogesterone
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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Medroxyprogesterone acetate
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Medroxyprogesterone
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 14,992 documents
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Safety
Black-box Warning
Black-box warning for: Depo-provera, Depo-subq provera, Depo-subq provera 104, Medroxyprogesterone acetate injectable suspension, Premphase, Premphase prempro, Prempro, Provera
Adverse Events
Top Adverse Reactions
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57,789 adverse events reported
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