Progesterone
Bijuva, Crinone, Endometrin, 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 cation channel sperm-associated protein 2, cation channel sperm-associated protein 4, short transient receptor potential channel 5, cation channel sperm-associated protein 3, mineralocorticoid receptor, cation channel sperm-associated protein 1, and nuclear receptor coactivator 2.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
---|---|
urogenital diseases | D000091642 |
signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Crinone, Endometrin, Prometrium (generic drugs available since 2001-04-25, discontinued: Milprosa, Progestasert)
CombinationsBijuva (generic drugs available since 2001-04-25)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Estradiol
+
Progesterone
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
BIJUVA | Mayne Group | N-210132 RX | 2018-10-28 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
bijuva | New Drug Application | 2021-06-30 |
crinone | New Drug Application | 2019-01-16 |
endometrin | New Drug Application | 2020-11-25 |
progesterone | ANDA | 2023-06-15 |
prometrium | New Drug Application | 2022-10-27 |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
PROGESTERONE, MILPROSA, FERRING PHARMS INC | |||
2023-04-29 | NP |
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Estradiol / Progesterone, Bijuva, Mayne Pharma | |||
8633178 | 2032-11-21 | DP | |
8846648 | 2032-11-21 | U-2439 | |
8846649 | 2032-11-21 | DP | U-2439 |
8933059 | 2032-11-21 | DP | U-2439 |
8987237 | 2032-11-21 | DP | |
8993548 | 2032-11-21 | DP | |
8993549 | 2032-11-21 | DP | |
9006222 | 2032-11-21 | DP | U-2439 |
9114145 | 2032-11-21 | U-2439 | |
9114146 | 2032-11-21 | DP | U-2439 |
9301920 | 2032-11-21 | DP | U-2439 |
10052386 | 2032-11-21 | DP | |
10206932 | 2032-11-21 | U-2439 | |
10639375 | 2032-11-21 | DP | |
10675288 | 2032-11-21 | U-2439 | |
10806740 | 2032-11-21 | DP | U-2439 |
11033626 | 2032-11-21 | DP | U-2439 |
11103513 | 2032-11-21 | U-2439 | |
11103516 | 2032-11-21 | DP | |
11110099 | 2032-11-21 | DP | |
11166963 | 2032-11-21 | DP | |
11529360 | 2032-11-21 | DP | |
Progesterone, Milprosa, Ferring Pharms Inc | |||
8580293 | 2030-01-21 | U-2810 | |
10537584 | 2029-02-03 | DP | |
10548904 | 2029-02-03 | U-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
Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | PROGESTERONE |
INN | progesterone |
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 class | progestins; steroids (androgens, anabolics); antiandrogens |
Image (chem structure or protein) | |
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 |
Target
Alternate
CATSPER2
CATSPER2
CATSPER4
CATSPER4
TRPC5
TRPC5
CATSPER3
CATSPER3
NR3C2
NR3C2
CATSPER1
CATSPER1
NCOA2
NCOA2
Variants
Clinical Variant
No data
Financial
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Tabular view
Trends
PubMed Central
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Additional graphs summarizing 148,527 documents
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Safety
Black-box Warning
Black-box warning for: Bijuva, Progesterone, Prometrium
Adverse Events
Top Adverse Reactions
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673 adverse events reported
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