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Drug ReportsLevonorgestrel
Levonorgestrel
Afirmelle, Altavera, Ashlyna, Athentia Next, Aviane, Ayuna, Balcoltra, Climara, Daysee, Dolishale, Enpresse, Fallback Solo, Falmina, Her Style, Iclevia, Introvale, Jaimiess, Kurvelo, Kyleena, Lessina, Levonest, Levonorgestrel, Levora, Liletta, Loseasonique, Marlissa, Minzoya, Mirena, Myzilra, One-step, Portia, Quartette, Quasense, Seasonale, Seasonique, Setlakin, Simpesse, Skyla, Trivora, Twirla, Tyblume, Vienva (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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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
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Completion date
Results first post date
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Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Athentia next, Fallback solo, Her style, Kyleena, Levonorgestrel, Liletta, Mirena, Opcicon one-step, Plan b one-step, Skyla (discontinued: Jadelle, Levonorgestrel, Norplant, Norplant system, Plan b)
Combinations
Afirmelle, Altavera, Ashlyna, Aviane, Ayuna, Balcoltra, Climara, Daysee, Dolishale, Enpresse, Falmina, Iclevia, Introvale, Jaimiess, Kurvelo, Lessina, Levonest, Levonorgestrel ethinyl estradiol, Levonorgestrel ethinyl estradiol ethinyl estradiol, Levonorgestrel ethinyl estradiol ferrous, Levora, Lo simpesse, Loseasonique, Marlissa, Minzoya, Myzilra, Portia, Quartette, Quasense, Seasonale, Seasonique, Setlakin, Simpesse, Trivora, Twirla, Tyblume, Vienva (discontinued: Alesse, Aviane, Cerinta, Elifemme, Enpresse, Fayosim, Lessina, Levlite, Levonorgestrel ethinyl estradiol, Levonorgestrel ethinyl estradiol ethinyl estradiol, 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)
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
LOSEASONIQUETevaN-022262 RX2008-10-24
1 products
QUARTETTETevaN-204061 RX2013-03-28
1 products, RLD, RS
SEASONALETevaN-021544 RX2003-09-05
1 products, RLD, RS
SEASONIQUETevaN-021840 RX2006-05-25
1 products, RLD, RS
Show 8 discontinued
Levonorgestrel
Tradename
Company
Number
Date
Products
KYLEENABayerN-208224 RX2016-09-16
1 products, RLD, RS
MIRENABayerN-021225 RX2000-12-06
1 products, RLD, RS
SKYLABayerN-203159 RX2013-01-09
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
Estradiol
+
Levonorgestrel
Tradename
Company
Number
Date
Products
CLIMARA PROBayerN-021258 RX2003-11-21
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
afirmelleANDA2024-09-19
after bangerANDA2024-10-15
afteraNDA authorized generic2023-01-31
afterpillANDA2023-05-01
afterplanANDA2018-10-26
altaveraANDA2023-03-02
amazon basic care levonorgestrelANDA2024-10-15
amethiaANDA2024-03-01
amethystANDA2022-01-31
ashlynaANDA2023-12-10
Show 95 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
Agency Specific
FDA
EMA
Expiration
Code
LEVONORGESTREL, LILETTA, MEDICINES360
2026-06-29I-917
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
105615242029-09-16U-2948
118501822029-09-14DPU-3819
116280882027-02-07DP
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
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
710 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———1911—52199
TuberculosisD014376EFO_0000774A15-A19728216962
InfectionsD007239EFO_0000544—62146634
Pulmonary tuberculosisD014397EFO_1000049A15119171233
PneumoniaD011014EFO_0003106J18—5145731
CataractD002386EFO_0001059H26.933320431
Communicable diseasesD003141———2136122
ContraceptionD003267——4562320
Multidrug-resistant tuberculosisD018088EFO_0007381——683416
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.95144—13
Show 74 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B208—1—211
KeratitisD007634—H16—17—29
Bacterial pneumoniaD018410EFO_1001272J15.9—26——8
Acquired immunodeficiency syndromeD000163EFO_0000765B205—1——6
Community-acquired infectionsD017714———24——6
NeoplasmsD009369—C80211—15
Breast neoplasmsD001943EFO_0003869C50113——5
KeratoconusD007640EFO_0004223H18.6111—35
Otitis mediaD010033EFO_0004992H66.9—12—14
Mycobacterium infectionsD009164—A31.9113——4
Show 67 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PharmacokineticsD010599——161———17
Pharmacological phenomenaD000069437——31———4
Parkinson diseaseD010300EFO_0002508G2031———4
OsteomyelitisD010019EFO_0003102M8611———2
AmenorrheaD000568—N91.212———2
HemorrhageD006470MP_0001914R5811———2
CholangitisD002761HP_0030151K83.0—1———1
HypoxiaD000860—R09.02—1———1
H1n1 subtype influenza a virusD053118———1———1
Tobacco use disorderD014029—F17—1———1
Show 10 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Long qt syndromeD008133HP_0001657I45.814———37
Type 2 diabetes mellitusD003924EFO_0001360E117————7
Hepatitis cD006526—B19.27————7
Diabetes mellitusD003920EFO_0000400E08-E136————6
Therapeutic equivalencyD013810——6————6
SchizophreniaD012559EFO_0000692F205————5
HypertensionD006973EFO_0000537I104————4
Drug interactionsD004347——4————4
AsthmaD001249EFO_0000270J454————4
Alzheimer diseaseD000544EFO_0000249F034————4
Show 85 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AppendicitisD001064EFO_0007149K37————44
Pathologic dilatationD004108——————33
RegenerationD012038——————33
Macular degenerationD008268EFO_0001365H35.30————22
Wounds and injuriesD014947—T14.8————22
PeritonitisD010538EFO_0008588K65————22
Pneumococcal pneumoniaD011018EFO_1001474J13————11
Pneumococcal infectionsD011008EFO_0000772J13————11
Urinary tract infectionsD014552EFO_0003103N39.0————11
Aortic dissectionD000784—I71.0————11
Show 26 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLevonorgestrel
INNlevonorgestrel
Description
Norgestrel is a progestin which is used in birth control pills sold under the brand name Ovral in combination with the estrogen ethinylestradiol and Opill by itself. It is also used in menopausal hormone therapy. It is taken by mouth.
Classification
Small molecule
Drug classestrogens; progestins
Image (chem structure or protein)Loading
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
No data
Financial
Revenue by drug
$
€
£
â‚£
Liletta – Allergan
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Liletta – Warner Chilcott
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Estimated US medical usage
Levonorgestrel
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Estradiol
Total medical expenditures per year (USD, in millions)
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Levonorgestrel
+
Ethinyl estradiol
Total medical expenditures per year (USD, in millions)
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Levonorgestrel
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,276 documents
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Safety
Black-box Warning
Black-box warning for: Altavera, Amethia, Ashlyna, Ayuna, Balcoltra, Camrese, Camrese lo, Camreselo, Chateal eq, Climara, Climara pro, Climarapro, Cryselle, Daysee, Elinest, Iclevia, Introvale, Jaimiess, Jolessa, Joyeaux, Kurvelo, Levonorgestrel and ethinyl estradiol, Levonorgestrel and ethinyl estradiol and ethinyl estradiol, Levonorgestrel/ethinyl estradiol and ethinyl estradiol, Levora, Lo simpesse, Lojaimiess, Loseasonique, Low-ogestrel, Marlissa, Minzoya, Myzilra, Portia, Rivelsa, Seasonique, Setlakin, Simpesse, Turqoz, Twirla, Tyblume
Adverse Events
Top Adverse Reactions
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175,684 adverse events reported
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