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Levonorgestrel
Athentia Next, Balcoltra, Climara, Fallback Solo, Her Style, Kyleena, Liletta, Loseasonique, Mirena, One-step, Quartette, Seasonale, Seasonique, Skyla, Twirla, Tyblume (levonorgestrel) is a small molecule pharmaceutical. Levonorgestrel was first approved as Nordette-21 on 1982-05-10. The pharmaceutical is active against progesterone receptor.
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Top 200 Pharmaceuticals by Retail Sales
Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Athentia next, Fallback solo, Her style, Kyleena, Liletta, Mirena, Opcicon one-step, Plan b one-step, Skyla (generic drugs available since 1993-12-13, discontinued: Jadelle, Norplant, Norplant system, Plan b)
Combinations
Balcoltra, Climara, Loseasonique, Quartette, Seasonale, Seasonique, Twirla, Tyblume (generic drugs available since 1993-12-13, discontinued: Alesse, Aviane, Cerinta, Elifemme, Enpresse, Fayosim, Lessina, Levlite, Levora, Lybrel, Nordette, Orsythia, Portia, Preven emergency contraceptive, Sylevia, Triphasil, Trivora)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Estradiol
+
Levonorgestrel
Tradename
Company
Number
Date
Products
CLIMARA PROBayerN-021258 RX2003-11-21
1 products, RLD, RS
Ethinyl estradiol
+
Levonorgestrel
Tradename
Company
Number
Date
Products
TWIRLAAgile TherapeuticsN-204017 RX2020-02-14
1 products, RLD, RS
BALCOLTRAAvion PharmaceuticalsN-208612 RX2018-01-09
1 products, RLD, RS
TYBLUMEExeltisN-209405 RX2020-03-30
1 products, RLD, RS
SEASONALETevaN-021544 RX2003-09-05
1 products, RLD, RS
SEASONIQUETevaN-021840 RX2006-05-25
1 products, RLD, RS
LOSEASONIQUETevaN-022262 RX2008-10-24
1 products
QUARTETTETevaN-204061 RX2013-03-28
1 products, RLD, RS
Show 8 discontinued
Levonorgestrel
Tradename
Company
Number
Date
Products
MIRENABayerN-021225 RX2000-12-06
1 products, RLD, RS
SKYLABayerN-203159 RX2013-01-09
1 products, RLD, RS
KYLEENABayerN-208224 RX2016-09-16
1 products, RLD, RS
PLAN B ONE-STEPFoundation Consumer HealthcareN-021998 OTC2009-07-10
1 products, RLD, RS
LILETTAMedicines360N-206229 RX2015-02-26
1 products, RLD, RS
Show 5 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
afirmelleANDA2021-12-06
altaveraANDA2023-03-02
ashlynaANDA2021-05-31
athentia nextANDA2019-09-23
avianeANDA2022-11-15
ayunaANDA2021-11-26
balcoltraNew Drug Application2019-12-10
climara proNew Drug Application2023-03-29
daysee ANDA2019-11-27
dolishaleANDA2021-01-03
Show 32 more
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
LEVONORGESTREL, MIRENA, BAYER HLTHCARE
2023-08-20D-181
ETHINYL ESTRADIOL / LEVONORGESTREL, TYBLUME, EXELTIS USA INC
2023-03-30NDF
ETHINYL ESTRADIOL / LEVONORGESTREL, TWIRLA, AGILE
2023-02-14NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Levonorgestrel, Liletta, Medicines360
115713282040-09-07DP
100288582034-03-22DPU-2348
110901862033-10-24U-2348
Levonorgestrel, Kyleena, Bayer Hlthcare
96689122031-04-01DP
109872442031-04-01DP
96159652029-09-16DPU-2003
105615242029-09-16U-2948
72528392023-11-13DP
Ethinyl Estradiol / Levonorgestrel, Quartette, Teva Branded Pharm
84153322029-03-11DP
84502992025-10-07U-1
Ethinyl Estradiol / Levonorgestrel, Loseasonique, Teva Branded Pharm
78551902028-12-05U-1
78586052023-06-23DP
76155452023-06-15U-1
Ethinyl Estradiol / Levonorgestrel, Twirla, Agile
82469782028-08-26DP
87478882028-07-10DP
90503482028-07-10DP
Ethinyl Estradiol / Levonorgestrel, Balcoltra, Avion Pharms
78380422027-06-01DPU-3251
Ethinyl Estradiol / Levonorgestrel, Seasonique, Teva Branded Pharm
73209692024-01-30U-828
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
— G03AA07: Levonorgestrel and ethinylestradiol
— G03AB: Progestogens and estrogens systemic contraceptives, sequential preparations
— G03AB03: Levonorgestrel and ethinylestradiol
— G03AC: Progestogen systemic hormonal contraceptives
— G03AC03: Levonorgestrel
— G03AD: Emergency contraceptive drugs
— G03AD01: Levonorgestrel
— G03F: Progestogens and estrogens in combination
— G03FA: Progestogens and estrogens, fixed combinations
— G03FA11: Levonorgestrel and estrogen
— G03FB: Progestogens and estrogens, sequential preparations
— G03FB09: Levonorgestrel and estrogen
HCPCS
Code
Description
J7296
Levonorgestrel-releasing intrauterine contraceptive system, (kyleena), 19.5 mg
J7297
Levonorgestrel-releasing intrauterine contraceptive system (liletta), 52 mg
J7298
Levonorgestrel-releasing intrauterine contraceptive system (mirena), 52 mg
J7301
Levonorgestrel-releasing intrauterine contraceptive system (skyla), 13.5 mg
J7306
Levonorgestrel (contraceptive) implant system, including implants and supplies
S4981
Insertion of levonorgestrel-releasing intrauterine system
Clinical
Clinical Trials
742 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ContraceptionD0032671715283026115
MenopauseD008593EFO_0003922N95971214646
InfertilityD007246EFO_0000545224122039
Healthy volunteers/patients—31622138
Breast neoplasmsD001943EFO_0003869C5011221621
EndometriosisD004715EFO_0001065N801485219
Endometrial hyperplasiaD004714N85.0—1172318
Hot flashesD019584—383317
Polycystic ovary syndromeD011085EFO_0000660E28.23——6716
MenorrhagiaD008595N92.0——93416
Show 74 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Endometrial neoplasmsD016889EFO_0004230—63—18
AdenomyosisD062788EFO_1001757N80.0——1—67
Prostatic neoplasmsD011471C61—52——6
Premenstrual syndromeD011293N94.3113—16
Anorexia nervosaD000856EFO_0004215F50.0221——5
SchizophreniaD012559EFO_0000692F20—32——5
Migraine disordersD008881EFO_0003821G43132——5
HypertensionD006973EFO_0000537I10—21——3
Metabolic bone diseasesD001851HP_0000938—12——3
AtrophyD001284—21——3
Show 18 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Covid-19D000086382U07.1—3———3
Ovulation inhibitionD03444512———3
HemostasisD006487—2———2
NeoplasmsD009369C8011———2
Endometrioid carcinomaD018269—2———2
Feeding and eating disordersD001068F50—2———2
Bulimia nervosaD052018EFO_0005204F50.2—2———2
Temporomandibular joint disordersD013705M26.6—1——12
FibromyalgiaD005356EFO_0005687M79.1—1——12
TuberculosisD014376EFO_0000774A15-A19—1———1
Show 26 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Therapeutic equivalencyD01381010———111
PharmacokineticsD0105996————6
Drug interactionsD0043473———25
Type 2 diabetes mellitusD003924EFO_0001360E113———14
Type 1 diabetes mellitusD003922EFO_0001359E101———12
Hepatitis cD006526B19.22————2
Systemic lupus erythematosusD008180EFO_0002690M321———12
InfectionsD007239EFO_00005441————1
TransgenesD0190761————1
Cerebral arterial diseasesD002539EFO_10008591————1
Show 12 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PregnancyD011247EFO_0002950Z33.1————44
Heart failureD006333EFO_0003144I50————33
Psychological sexual dysfunctionsD020018F52.0————22
Pregnancy rateD018873————22
Hormonal contraceptionD000080282————22
Heart disease risk factorsD000082742————11
Premature menopauseD008594HP_0008209E28.31————11
Blood coagulation disordersD001778EFO_0009314D68.9————11
Breast densityD000071060————11
Cognitive dysfunctionD060825G31.84————11
Show 26 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLEVONORGESTREL
INNlevonorgestrel
Description
Norgestrel, sold under the brand name Ovral among others, is a progestin medication which is used in birth control pills and in menopausal hormone therapy. It is available both in combination with an estrogen and alone. It is taken by mouth.
Classification
Small molecule
Drug classestrogens; progestins
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
C#C[C@]1(O)CC[C@H]2[C@@H]3CCC4=CC(=O)CC[C@@H]4[C@H]3CC[C@@]21CC
Identifiers
PDB—
CAS-ID6533-00-2
RxCUI—
ChEMBL IDCHEMBL1389
ChEBI ID6443
PubChem CID16051930
DrugBankDB00367
UNII ID5W7SIA7YZW (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
Clinical Variant
No data
Financial
Liletta - Allergan
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Liletta - Warner Chilcott
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 12,544 documents
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Safety
Black-box Warning
Black-box warning for: Altavera, Ashlyna, Ayuna, Balcoltra, Climara pro, Daysee , Fayosim , Iclevia, Introvale, Jaimiess, Kurvelo , Levora, Lo simpesse, Loseasonique, Marlissa, Myzilra, Portia, Quartette, Rivelsa, Seasonique, Setlakin , Twirla, Tyblume
Adverse Events
Top Adverse Reactions
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29,262 adverse events reported
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