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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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)
CombinationsAfirmelle, 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 |
|---|---|---|---|---|
| TWIRLA | Agile Therapeutics | N-204017 RX | 2020-02-14 | 1 products, RLD, RS |
| BALCOLTRA | Avion Pharmaceuticals | N-208612 RX | 2018-01-09 | 1 products, RLD, RS |
| TYBLUME | Exeltis | N-209405 RX | 2020-03-30 | 1 products, RLD, RS |
| LOSEASONIQUE | Teva | N-022262 RX | 2008-10-24 | 1 products |
| QUARTETTE | Teva | N-204061 RX | 2013-03-28 | 1 products, RLD, RS |
| SEASONALE | Teva | N-021544 RX | 2003-09-05 | 1 products, RLD, RS |
| SEASONIQUE | Teva | N-021840 RX | 2006-05-25 | 1 products, RLD, RS |
Show 8 discontinued
Levonorgestrel
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| KYLEENA | Bayer | N-208224 RX | 2016-09-16 | 1 products, RLD, RS |
| MIRENA | Bayer | N-021225 RX | 2000-12-06 | 1 products, RLD, RS |
| SKYLA | Bayer | N-203159 RX | 2013-01-09 | 1 products, RLD, RS |
| PLAN B ONE-STEP | Foundation Consumer Healthcare | N-021998 OTC | 2009-07-10 | 1 products, RLD, RS |
| LILETTA | Medicines360 | N-206229 RX | 2015-02-26 | 1 products, RLD, RS |
Show 5 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| afirmelle | ANDA | 2024-09-19 |
| after banger | ANDA | 2024-10-15 |
| aftera | NDA authorized generic | 2023-01-31 |
| afterpill | ANDA | 2023-05-01 |
| afterplan | ANDA | 2018-10-26 |
| altavera | ANDA | 2023-03-02 |
| amazon basic care levonorgestrel | ANDA | 2024-10-15 |
| amethia | ANDA | 2024-03-01 |
| amethyst | ANDA | 2022-01-31 |
| ashlyna | ANDA | 2023-12-10 |
Show 96 more
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
LEVONORGESTREL, LILETTA, MEDICINES360 | |||
| 2026-06-29 | I-917 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Levonorgestrel, Liletta, Medicines360 | |||
| 11571328 | 2040-09-07 | DP | |
| 10028858 | 2034-03-22 | DP | U-2348 |
| 11090186 | 2033-10-24 | U-2348 | |
| Levonorgestrel, Kyleena, Bayer Hlthcare | |||
| 10561524 | 2029-09-16 | U-2948 | |
| 11850182 | 2029-09-14 | DP | U-3819 |
| 11628088 | 2027-02-07 | DP | |
| Ethinyl Estradiol / Levonorgestrel, Quartette, Teva Branded Pharm | |||
| 8415332 | 2029-03-11 | DP | |
| 8450299 | 2025-10-07 | U-1 | |
| Ethinyl Estradiol / Levonorgestrel, Loseasonique, Teva Branded Pharm | |||
| 7855190 | 2028-12-05 | U-1 | |
| Ethinyl Estradiol / Levonorgestrel, Twirla, Agile | |||
| 8246978 | 2028-08-26 | DP | |
| 8747888 | 2028-07-10 | DP | |
| 9050348 | 2028-07-10 | DP | |
| Ethinyl Estradiol / Levonorgestrel, Balcoltra, Avion Pharms | |||
| 7838042 | 2027-06-01 | DP | U-3251 |
| Ethinyl Estradiol / Levonorgestrel, Seasonique, Teva Branded Pharm | |||
| 7320969 | 2024-01-30 | U-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
2599 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Contraception | D003267 | — | — | 29 | 30 | 62 | 46 | 73 | 236 |
| Healthy volunteers/patients | — | — | — | 145 | 11 | 7 | 6 | 10 | 172 |
| Infertility | D007246 | HP_0000789 | — | 14 | 18 | 17 | 33 | 73 | 148 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 11 | 30 | 9 | 2 | 39 | 86 |
| Syndrome | D013577 | — | — | 8 | 14 | 16 | 17 | 29 | 83 |
| Neoplasms | D009369 | — | C80 | 46 | 20 | 4 | 2 | 24 | 81 |
| Menopause | D008593 | EFO_0003922 | N95 | 12 | 11 | 15 | 23 | 19 | 76 |
| Lymphoma | D008223 | — | C85.9 | 29 | 23 | 8 | 1 | 9 | 61 |
| Hemorrhage | D006470 | MP_0001914 | R58 | 4 | 10 | 13 | 11 | 24 | 58 |
| Endometriosis | D004715 | EFO_0001065 | N80 | 3 | 14 | 18 | 15 | 10 | 56 |
Show 239 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell lymphoma | D016393 | — | — | 18 | 13 | 2 | — | 6 | 36 |
| Prostatic neoplasms | D011471 | — | C61 | 6 | 13 | 7 | — | 7 | 30 |
| Non-small-cell lung carcinoma | D002289 | — | — | 11 | 13 | 5 | — | 6 | 29 |
| Leukemia | D007938 | — | C95 | 15 | 14 | 3 | — | 3 | 28 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 4 | 10 | 5 | — | 11 | 28 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 7 | 12 | 3 | — | 5 | 24 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | — | 15 | 7 | — | 4 | 23 |
| Adenocarcinoma | D000230 | — | — | 3 | 9 | 2 | — | 3 | 15 |
| Dementia | D003704 | EFO_0003862 | F03 | 1 | — | 1 | — | 13 | 15 |
| Lymphoid leukemia | D007945 | — | C91 | 7 | 8 | 2 | — | 1 | 14 |
Show 123 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | — | — | 18 | 1 | — | — | 1 | 19 |
| Tissue adhesions | D000267 | — | — | 3 | 1 | — | — | 11 | 14 |
| Glioblastoma | D005909 | EFO_0000515 | — | 7 | 6 | — | — | 1 | 11 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 7 | 5 | — | — | 1 | 10 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 4 | 1 | — | — | 5 | 10 |
| Weight loss | D015431 | HP_0001824 | — | — | 1 | — | — | 8 | 9 |
| Myeloid leukemia | D007951 | — | C92 | 4 | 4 | — | — | 1 | 8 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 8 | 3 | — | — | — | 8 |
| Mantle-cell lymphoma | D020522 | — | — | 8 | 4 | — | — | — | 8 |
| Melanoma | D008545 | — | — | 5 | 4 | — | — | 1 | 7 |
Show 144 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 2 | — | — | — | 15 | 17 |
| Therapeutic equivalency | D013810 | — | — | 11 | — | — | — | 1 | 12 |
| Hepatitis c | D006526 | — | B19.2 | 7 | — | — | — | 3 | 10 |
| Asthma | D001249 | EFO_0000270 | J45 | 5 | — | — | — | 4 | 9 |
| Drug interactions | D004347 | — | — | 6 | — | — | — | 2 | 8 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | — | — | — | 6 | 7 |
| Ewing sarcoma | D012512 | EFO_0000173 | — | 3 | — | — | — | 1 | 4 |
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | 1 | — | — | — | 3 | 4 |
| Hemostatic disorders | D020141 | — | — | 1 | — | — | — | 3 | 4 |
| Astrocytoma | D001254 | EFO_0000271 | — | 3 | — | — | — | 1 | 4 |
Show 79 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | — | — | — | 10 | 10 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | — | — | — | 10 | 10 |
| Exercise | D015444 | EFO_0000483 | — | — | — | — | — | 9 | 9 |
| Attempted suicide | D013406 | EFO_0004321 | T14.91 | — | — | — | — | 7 | 7 |
| Autism spectrum disorder | D000067877 | HP_0000729 | F84.0 | — | — | — | — | 7 | 7 |
| Alcohol drinking | D000428 | EFO_0004329 | — | — | — | — | — | 6 | 6 |
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | — | — | — | — | 6 | 6 |
| Thromboembolism | D013923 | HP_0001907 | — | — | — | — | — | 6 | 6 |
| Health behavior | D015438 | — | — | — | — | — | — | 6 | 6 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | — | — | — | 6 | 6 |
Show 432 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Levonorgestrel |
| INN | levonorgestrel |
| 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 class | estrogens; 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-ID | 6533-00-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1389 |
| ChEBI ID | 6443 |
| PubChem CID | 16051930 |
| DrugBank | DB00367 |
| UNII ID | 5W7SIA7YZW (ChemIDplus, GSRS) |
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Liletta – Allergan
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Liletta – Warner Chilcott
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Estimated US medical usage
Levonorgestrel
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Estradiol
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Levonorgestrel
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Ethinyl estradiol
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Levonorgestrel
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Trends
PubMed Central
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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, Myzilra, Portia, Quartette, Rivelsa, Seasonique, Setlakin, Simpesse, Turqoz, Twirla, Tyblume
Adverse Events
Top Adverse Reactions
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210,556 adverse events reported
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