Tradename | Company | Number | Date | Products |
---|---|---|---|---|
NEXTSTELLIS | Mayne Group | N-214154 RX | 2021-04-15 | 1 products, RLD, RS |
Brand Name | Status | Last Update |
---|---|---|
angeliq | New Drug Application | 2023-12-08 |
beyaz | New Drug Application | 2023-05-19 |
drospirenone and ethinyl estradiol | ANDA | 2024-09-27 |
drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium | ANDA | 2024-08-12 |
drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium | NDA authorized generic | 2023-05-19 |
gianvi | New Drug Application | 2010-11-03 |
jasmiel | ANDA | 2024-05-14 |
lo-zumandimine | ANDA | 2023-10-09 |
loryna | ANDA | 2024-01-10 |
nextstellis | New Drug Application | 2023-05-11 |
Expiration | Code | ||
---|---|---|---|
DROSPIRENONE / ESTETROL, NEXTSTELLIS, MAYNE PHARMA | |||
2026-04-15 | NCE | ||
DROSPIRENONE, DROSPIRENONE, EXELTIS USA INC | |||
2025-06-29 | NP |
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Drospirenone / Estradiol, Angeliq, Bayer Hlthcare | |||
8906890 | 2031-10-22 | DP | |
Drospirenone, Drospirenone, Exeltis Usa Inc | |||
9603860 | 2031-06-28 | U-2553 | |
10179140 | 2031-06-28 | U-2553 | |
10603281 | 2031-06-28 | U-2553 | |
10849857 | 2031-06-28 | DP | U-2553 |
10987364 | 2031-06-28 | DP | |
11123299 | 2031-06-28 | DP | |
11291632 | 2031-06-28 | DP | |
11291633 | 2031-06-28 | DP | |
11351122 | 2031-06-28 | DP | |
11413249 | 2031-06-28 | U-2553 | |
11439598 | 2031-06-28 | DP | |
11478487 | 2031-06-28 | DP | |
11504334 | 2031-06-28 | DP | |
Drospirenone / Ethinyl Estradiol / Levomefolate Calcium, Beyaz, Bayer Hlthcare | |||
8617597 | 2030-02-08 | DP | |
Drospirenone / Estetrol, Nextstellis, Mayne Pharma | |||
7732430 | 2025-03-02 | DP | U-3152 |
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Contraception | D003267 | — | — | 3 | 1 | 12 | 1 | 9 | 26 |
Postmenopause | D017698 | — | — | — | 1 | 2 | 1 | 1 | 5 |
Healthy volunteers/patients | — | — | — | — | — | 1 | 1 | — | 2 |
Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | 1 | — | 1 |
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Acne vulgaris | D000152 | EFO_0003894 | L70 | — | — | 4 | — | 2 | 6 |
Dysmenorrhea | D004412 | — | N94.6 | — | 2 | 5 | — | 1 | 6 |
Hot flashes | D019584 | — | — | — | — | 3 | — | — | 3 |
Hypertension | D006973 | EFO_0000537 | I10 | — | 1 | 1 | — | — | 2 |
Ovulation inhibition | D034445 | — | — | — | — | 1 | — | — | 1 |
Neural tube defects | D009436 | — | Q00.0 | — | — | 1 | — | — | 1 |
Spinal dysraphism | D016135 | EFO_1001210 | Q05 | — | — | 1 | — | — | 1 |
Essential hypertension | D000075222 | — | I10 | — | — | 1 | — | — | 1 |
Endometriosis | D004715 | EFO_0001065 | N80 | — | — | 1 | — | — | 1 |
Premenstrual dysphoric disorder | D065446 | — | F32.81 | — | — | 1 | — | — | 1 |
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Hidradenitis suppurativa | D017497 | — | L73.2 | — | 1 | — | — | — | 1 |
Hidradenitis | D016575 | — | — | — | 1 | — | — | — | 1 |
Hormonal contraception | D000080282 | — | — | — | 1 | — | — | — | 1 |
Prehypertension | D058246 | — | — | — | 1 | — | — | — | 1 |
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Biological availability | D001682 | — | — | 1 | — | — | — | — | 1 |
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Premenstrual syndrome | D011293 | — | N94.3 | — | — | — | — | 2 | 2 |
Menopause | D008593 | EFO_0003922 | N95 | — | — | — | — | 1 | 1 |
Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | — | — | — | 1 | 1 |
Postmenopausal osteoporosis | D015663 | EFO_0003854 | — | — | — | — | — | 1 | 1 |
Depression | D003863 | — | F33.9 | — | — | — | — | 1 | 1 |
Depressive disorder | D003866 | EFO_1002014 | F32.A | — | — | — | — | 1 | 1 |
Venous thromboembolism | D054556 | EFO_0004286 | I74 | — | — | — | — | 1 | 1 |
Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | — | — | 1 | 1 |
Thromboembolism | D013923 | — | — | — | — | — | — | 1 | 1 |
Drug common name | Drospirenone |
INN | drospirenone |
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 class | aldosterone antagonists (spironolactone type) |
Image (chem structure or protein) | ![]() |
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 |
PDB | — |
CAS-ID | 67392-87-4 |
RxCUI | — |
ChEMBL ID | CHEMBL1509 |
ChEBI ID | 50838 |
PubChem CID | 68873 |
DrugBank | DB01395 |
UNII ID | N295J34A25 (ChemIDplus, GSRS) |