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Drug ReportsDrospirenone
Yasmin, Drovelis(drospirenone)
Angeliq, Beyaz, Drospirenone / Ethinyl Estradiol, Drospirenone / Ethinyl Estradiol /, Drovelis, Lo-zumandimine, Loryna, Lydisilka, Melamisa, Nextstellis, Nikki, Safyral, Slynd, Syeda, Tydemy, Yaela, Yasmin, Yaz, Zumandimine (drospirenone) is a small molecule pharmaceutical. Drospirenone was first approved as Yasmin on 2001-05-11. The pharmaceutical is active against mineralocorticoid receptor.
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FDA Novel Drug Approvals 2021
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
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
No data
Trade Name
FDA
EMA
Drospirenone, Slynd (discontinued: Drospirenone)
Combinations
Angeliq, Beyaz, Drospirenone ethinyl estradiol, Drospirenone, ethinyl estradiol levomefolate, Lo-zumandimine, Loryna, Melamisa, Nextstellis, Nikki, Safyral, Syeda, Tydemy, Yaela, Yasmin, Yaz, Zumandimine (discontinued: Drospirenone ethinyl estradiol, Kemeya, Kyra)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Drospirenone
+
Estetrol
Tradename
Company
Number
Date
Products
NEXTSTELLISMayne GroupN-214154 RX2021-04-15
1 products, RLD, RS
Drospirenone
+
Estradiol
Tradename
Company
Number
Date
Products
ANGELIQBayerN-021355 RX2005-09-28
2 products, RLD, RS
Drospirenone
+
Ethinyl estradiol
+
Levomefolate calcium
Tradename
Company
Number
Date
Products
BEYAZBayerN-022532 RX2010-09-24
1 products, RLD, RS
SAFYRALBayerN-022574 RX2010-12-16
1 products, RLD, RS
Drospirenone
+
Ethinyl estradiol
Tradename
Company
Number
Date
Products
YASMINBayerN-021098 RX2001-05-11
1 products, RLD, RS
YAZBayerN-021676 RX2006-03-16
1 products, RLD, RS
Drospirenone
Tradename
Company
Number
Date
Products
SLYNDExeltisN-211367 RX2019-05-23
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
angeliqNew Drug Application2023-12-08
beyazNew Drug Application2023-05-19
drospirenone and ethinyl estradiolANDA2024-09-27
drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calciumANDA2024-08-12
drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calciumNDA authorized generic2023-05-19
gianviNew Drug Application2010-11-03
jasmielANDA2024-05-14
lo-zumandimineANDA2023-10-09
lorynaANDA2024-01-10
nextstellisNew Drug Application2023-05-11
Show 11 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
prostatic neoplasms—D011471C61
breast neoplasmsEFO_0003869D001943C50
menorrhagiaEFO_0003945D008595N92.0
primary ovarian insufficiencyEFO_0004266D016649E28.3
hot flashes—D019584—
hypogonadism—D007006E23.0
premature menopause—D008594E28.31
folic acid deficiencyEFO_0001070D005494E53.8
megaloblastic anemia—D000749D53.1
Agency Specific
FDA
EMA
Expiration
Code
DROSPIRENONE / ESTETROL, NEXTSTELLIS, MAYNE PHARMA
2026-04-15NCE
DROSPIRENONE, DROSPIRENONE, EXELTIS USA INC
2025-06-29NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Drospirenone / Estradiol, Angeliq, Bayer Hlthcare
89068902031-10-22DP
Drospirenone, Drospirenone, Exeltis Usa Inc
96038602031-06-28U-2553
101791402031-06-28U-2553
106032812031-06-28U-2553
108498572031-06-28DPU-2553
109873642031-06-28DP
111232992031-06-28DP
112916322031-06-28DP
112916332031-06-28DP
113511222031-06-28DP
114132492031-06-28U-2553
114395982031-06-28DP
114784872031-06-28DP
115043342031-06-28DP
Drospirenone / Ethinyl Estradiol / Levomefolate Calcium, Beyaz, Bayer Hlthcare
86175972030-02-08DP
Drospirenone / Estetrol, Nextstellis, Mayne Pharma
77324302025-03-02DPU-3152
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
— G03AA12: Drospirenone and ethinylestradiol
— G03AA18: Drospirenone and estetrol
— G03AC: Progestogen systemic hormonal contraceptives
— G03AC10: Drospirenone
— G03F: Progestogens and estrogens in combination
— G03FA: Progestogens and estrogens, fixed combinations
— G03FA17: Drospirenone and estrogen
HCPCS
No data
Clinical
Clinical Trials
165 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ContraceptionD003267——31121926
PostmenopauseD017698———12115
Healthy volunteers/patients—————11—2
Cardiovascular diseasesD002318EFO_0000319I98———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Acne vulgarisD000152EFO_0003894L70——4—26
DysmenorrheaD004412—N94.6—25—16
Hot flashesD019584————3——3
HypertensionD006973EFO_0000537I10—11——2
Ovulation inhibitionD034445————1——1
Neural tube defectsD009436—Q00.0——1——1
Spinal dysraphismD016135EFO_1001210Q05——1——1
Essential hypertensionD000075222—I10——1——1
EndometriosisD004715EFO_0001065N80——1——1
Premenstrual dysphoric disorderD065446—F32.81——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hidradenitis suppurativaD017497—L73.2—1———1
HidradenitisD016575———1———1
Hormonal contraceptionD000080282———1———1
PrehypertensionD058246———1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Biological availabilityD001682——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Premenstrual syndromeD011293—N94.3————22
MenopauseD008593EFO_0003922N95————11
OsteoporosisD010024EFO_0003882M81.0————11
Postmenopausal osteoporosisD015663EFO_0003854—————11
DepressionD003863—F33.9————11
Depressive disorderD003866EFO_1002014F32.A————11
Venous thromboembolismD054556EFO_0004286I74————11
Breast neoplasmsD001943EFO_0003869C50————11
ThromboembolismD013923——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDrospirenone
INNdrospirenone
Description
Drospirenone is a steroid lactone and a 3-oxo-Delta(4) steroid. It has a role as a contraceptive drug, an aldosterone antagonist and a progestin.
Classification
Small molecule
Drug classaldosterone antagonists (spironolactone type)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
C[C@]12CC[C@H]3[C@H]([C@@H]1[C@@H]1C[C@@H]1[C@@]21CCC(=O)O1)[C@H]1C[C@H]1C1=CC(=O)CC[C@@]13C
Identifiers
PDB—
CAS-ID67392-87-4
RxCUI—
ChEMBL IDCHEMBL1509
ChEBI ID50838
PubChem CID68873
DrugBankDB01395
UNII IDN295J34A25 (ChemIDplus, GSRS)
Target
Agency Approved
NR3C2
NR3C2
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)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
No data
Estimated US medical usage
Drospirenone
+
Estradiol
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Refill frequency
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Price per prescription (USD)
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Drospirenone
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Ethinyl estradiol
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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Price per prescription (USD)
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Drospirenone
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Ethinyl estradiol
+
Levomefolate
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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,589 documents
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Safety
Black-box Warning
Black-box warning for: Angeliq, Beyaz, Drospirenone and ethinyl estradiol, Drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium, Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium, Jasmiel, Lo-zumandimine, Loryna, Nextstellis, Nikki, Ocella, Safyral, Syeda, Tydemy, Vestura, Yasmin, Yaz, Zarah, Zumandimine
Adverse Events
Top Adverse Reactions
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18,493 adverse events reported
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